What’s Ahead: This Week

Notable Policy Events –

  • Tuesday, September 19
    • Roll Call, “Tackling Mental Health Through Innovation.” Additional information: http://bit.ly/2xcUh1x
    • Patient-Centered Outcomes Research Institute (PCORI), “Addressing America’s Opioid Problem: The Need for Evidence-Based Strategies.” Additional information: http://bit.ly/2xdEO1h
    • Center for Strategic & International Studies, “Decades of the Global War on Drugs, Lessons Learned, and America’s Opioid Epidemic.” Additional information: http://bit.ly/2xcWV7t
    • Bloomberg, “The Future of Health Care: Unlocking & Supporting Value.” Additional information: http://bit.ly/2xdm025
  • Wednesday, September 20
    • National Coalition on Health Care, “Avoiding the Cliff: Strengthening the Primary Care Workforce.” Additional information: http://bit.ly/2xdiSU0
    • Washington Post, “Transformers Health.” Additional information: http://wapo.st/2xdjokZ
    • Bloomberg Government, “The Future of Innovation Waives: What States Can Do.” Additional information: http://bit.ly/2wBfMWj

Weekly Wrap-Up: Notable Health Care Developments From Last Week

Appropriations –

  • On September 14, the House passed by a vote of 211-198 an omnibus spending bill for fiscal year (FY) 2018 (H.R. 3354), which includes $77.6 billion in funding for the HHS, a decrease of $542 million from FY17 enacted levels. The bill now moves to the Senate for consideration. Congress has until December 8 to finalize spending for FY18. Press release: http://bit.ly/2xcUXnC

 Legislative Activity –

  • On September 11, Rep. Marchant (R-TX) introduced the Stark Administrative Simplification Act of 2017 (H.R. 3726), which would create alternative sanctions for technical noncompliance with the Stark rule under Medicare. Press release: http://bit.ly/2vZlFNt
  • Also on September 11, Rep. Black (R-TN) introduced the Increasing Access to Medicare Act (H.R. 3727) which would include additional telehealth services for purposes of MA organization bids. Press release: http://bit.ly/2vYQq5i
  • On September 13, House Energy & Commerce Committee, Subcommittee on Health advanced by a voice vote seven healthcare bills: the Furthering Access to Stroke Telemedicine Act of 2017 (H.R. 1148), the Steve Gleason Enduring Voices Act of 2017 (H.R. 2465), the Prostate Cancer Misdiagnosis Elimination Act of 2017 (H.R. 2557), H.R. 3120, The Medicare Civil and Criminal Penalties Act (H.R. 3245), H.R. 3263, and the Protecting Access to Diabetes Supplies Act of 2017 (H.R. 3271). The bills now move to the full Committee for consideration. Press release: http://bit.ly/2x43SHS
  • On September 13, Senate Finance Committee Chair Hatch (R-UT) and Sens. Schatz (D-HI), Coons, (D-DE), Gardner (R-CO) and Tillis (R-NC) introduced the Marijuana Effective Drug Study (MEDS) Act of 2017 (S. 1803), which would improve medical research on marijuana. Press release: http://bit.ly/2xdrXMG
  • Also on September 13, Reps. Stefanik (R-NY), Young (R-IA), Courtney (D-CT), and O’Halleran (D-AZ) introduced the Community Health Investment, Modernization and Excellence (CHIME) Act of 2017 (H.R. 3770) which would reauthorize and extend funding for community health centers. Press release: http://bit.ly/2vYv0Fi
  • On September 14, Sens. Markey (D-MA), Schatz (D-HI) and Whitehouse (D-RI) introduced the Climate Change Health Protection and Promotion Act (S. 1807), which would direct the Secretary of HHS to develop and strategic action plan and program to assist health professionals in preparing for and reporting to the public on the health effects of climate change. Rep. Cartright (D-PA) and 28 cosponsors introduced companion legislation in the House (H.R. 3782). Press release: http://bit.ly/2xdL0Xk
  • Also on September 14, Reps. Walorski (R-IN) and Lipinski (D-IL) introduced the Save American Workers Act (H.R. 3798) which would repeal the 30-hour threshold for classification as a full-time employee for purposes of the employer mandate in the ACA and replace it with 40 hours. Press release: http://bit.ly/2vZ83Sp

 ACA Market Stabilization & Reform –

  • On September 12, House Committee on Energy & Commerce, Subcommittee on Health Chair Burgess (R-TX) and House Ways & Means Committee Chair Brady (R-TX) introduced H.R. 3725, which would repeal the ACA’s individual mandate. Press release: http://bit.ly/2wqnEKf Bill text: http://bit.ly/2wq0qUB
  • Also on September 12, Higgins (D-NY) and 34 Democratic cosponsors introduced the Medicare Buy-In and Health Care Stabilization Act (H.R. 3748), which would provide for an option for individuals who are ages 50-64 to buy into Medicare and would provide for health insurance market stabilization. Press release: http://bit.ly/2wqbqkT
  • On September 13, Sens. Graham (R-SC), Cassidy (R-LA), Heller (R-NV), and Johnson (R-WI) released legislative text for their ACA repeal and replace proposal, which would amend the Better Care Reconciliation Act to block grant ACA funding to states to develop their own solutions to their healthcare markets. Press release: http://bit.ly/2x2wL7F FAQ: http://bit.ly/2x5zi0H Section-by-section: http://bit.ly/2x1NY0IBill text: http://bit.ly/2x263ff
  • Also on September 13, Sen. Sanders (I-VT) and 16 Democratic cosponsors introduced the Medicare for All Act (S. 1804), which would establish a Medicare-for-all national health insurance program, called the Universal Medicare Program (UMP). Press release: http://bit.ly/2x2JyHc Summary: http://bit.ly/2x2fDP3 Section-by-section: http://bit.ly/2x2Cs5cFinancing options: http://bit.ly/2x2xZQb Bill text: http://bit.ly/2x1O3l1
  • Also on September 13, House Ways & Means Committee Ranking Member Neal (D-MA) and Health Subcommittee Ranking Member Levin (D-MI) sent a letter to Chair Brady (R-TX) requesting that the Committee on bipartisan ACA hearings. Press release: http://bit.ly/2xdwzlZ Letter: http://bit.ly/2xdaaFb
  • On September 14, Sen. Barrasso (R-WY) sent a letter to the Congressional Budget Office (CBO) asking for a full cost estimate of Sen. Sander’s proposal, noting that he was “deeply concerned that Senator Sanders’ Medicare-for-All legislation is not only a government takeover of health care, but would also put financial burdens on the American people that they cannot sustain.” Barrasso Press release: http://bit.ly/2x5yQzB Letter: http://bit.ly/2x5cPRr
  • Also on September 14, Sen. Enzi (R-WY) introduced the Small Business Health Plans Act (S. 1818(, which would provide healthcare options for small businesses. Press release: http://bit.ly/2xdJyUS
  • On September 15, the New Democrat Coalition, a group of 35 Democratic House members, sent a letter to Senate HELP Committee Alexander (R-TN) and Ranking Member Murray (D-WA) calling for a path forward on legislative solutions to reduce healthcare costs, and highlighting a set of proposals to stabilize the individual insurance markets. Press release with text of letter: http://bit.ly/2xe5TBD

ACA Implementation –

  • On September 11, House Energy & Commerce Ranking Member Pallone (D-NJ), Subcommittee on Health Ranking Member Green (D-TX), Subcommittee on Oversight and Investigations DeGette (D-CO), and Vice Ranking Member of the Committee Castor (D-FL) sent a letter to HHS Secretary Price and CMS Administrator Verma raising concerns over the Administration’s plans to roll back funding for the ACA’s Navigator program and to cut funding for open enrollment marketing and advertisement. Press release: http://bit.ly/2x1jcFgLetter: http://bit.ly/2x1OoV2
  • Also on September 11, CMS marked Oregon’s section 1332 waiver as complete, beginning the 30-day public comment period. Oregon is requesting to implement a state-based reinsurance program to stabilize its individual insurance marketplace. Comments are due by October 11. CMS Letter: http://go.cms.gov/2wqo8zU Waiver: http://bit.ly/2wqRYEE
  • On September 12, Rep. Shea-Porter led a group of 31 House Democrats in a letter to HHS Secretary Price urging him to release promised funding for the ACA’s Navigator enrollment assistance grant program. Press release with text of letter: http://bit.ly/2xcM1i3
  • Also on September 12, S. Government Accountability Office (GAO) published a report recommending that CMS take six actions with respect to state marketplace oversight: ensure that states provide complete sustainability plans, complete financial audit reports, fully define risk assessment process, complete update performance measurement plans, align metrics with goals, and conduct operational analysis reviews. Summary with link to report: http://bit.ly/2wr7kZO
  • Also on September 12, HHS Office of the Inspector General (HHS OIG) released a report recommending that CMS continue to work with operational CO-OPs to improve their financial condition and continue the use of corrective action and enhanced oversight plans. Summary with link to report: http://bit.ly/2xdECiN
  • On September 14, CBO released a report on federal subsidies for health insurance coverage for people under the age of 65, finding that premiums for the ACA’s benchmark plans will increase by an average of 15 percent in plan year 2018 primarily because of “short-term market uncertainty.” It also projects lower enrollment into exchange plans “because of announced reductions in federal advertising, outreach, the enrollment period, and other enrollment efforts…” Report: http://bit.ly/2x5q8kO


  • On September 11, HHS OIG published a report finding that Medicare Part B paid for some immunosuppressive drugs that were not eligible for Part B payment. Report: http://bit.ly/2wqnCSA
  • On September 14, CMS announced a new redesign of Medicare Cards, which contains a unique, randomly-assigned number that replaces the current Social Security-based number. Press release: http://go.cms.gov/2xdwhva Blog post: http://bit.ly/2xdkflO

Medicaid and CHIP

  • On September 11, Senate Finance Committee Chair Hatch (R-UT) and Ranking Member Wyden (D-OR) announced an agreement to extend the Children’s Health Insurance Program for five years, which would decrease federal funding for CHIP over time. Current funding authorization is set to expire on September 30.Press release: http://bit.ly/2xdppxS
  • On September 13, the GAO published a report on CMS oversight of access and quality in states’ managed long term services and supports programs (MLTSS), recommending that CMS take steps to identify and obtain information to oversee key aspects of MLTSS access and quality, including network adequacy, critical incidents, and appeals and grievances. Summary with link to report: http://bit.ly/2vYMqSt

 Mental Health and Substance Abuse –

  • On September 11, Sen. Markey (D-MA) and 10 Democratic Senators wrote a letter to President Trump, urging him to take immediate action on the opioid crisis and answer specific questions about the promise to declare the epidemic a national emergency. Press release: http://bit.ly/2xdtfY3 Letter: http://bit.ly/2xdtn9Z
  • On September 12, House Energy & Commerce Chair Walden (R-OR) published an op-ed in Morning Consult highlighting steps the Committee intends to take to address the crisis, including by holding a hearing the week of October 23. Op-ed: http://bit.ly/2xdgZH0
  • Also on September 12, Substance Abuse and Mental Health Services Administration (SAMHSA) announced the availability of up to $14.5 million in grants over several years for suicide prevention programs. Press release: http://bit.ly/2vYOiux
  • On September 13, Gov. Christie (R-NJ), Chair of the President’s Commission on Combating Drug Addiction and the Opioid Crisis sent a letter to President Trump informing him that the Committee’s final recommendations will be submitted on November 1, rather than October 1, as originally scheduled. Letter: http://bit.ly/2xfOhFo
  • On September 14, Health Resources and Services Administration (HRSA) announced the award of more than $200 million to 1,178 health centers and 13 rural health organization in every U.S. state, DC, Puerto Rico, the Virgin Islands, and the Pacific Basin to increase access to substance abuse and mental health services. Press release: http://bit.ly/2vZxSBM
  • Also on September 14, the Food and Drug Administration (FDA) approved marketing for the first mobile medical application to help treat substance use disorders and is used with outpatient therapy to treat alcohol, cocaine, marijuana, and stimulant substance use disorders. Press release: http://bit.ly/2vYQSkc
  • On September 15, HHS announced an award of $144.1 million in grants to prevent and treat opioid addiction. Press release: http://bit.ly/2vZuWFs
  • Also on September 15, National Institutes of Health announced that several emergency department-based interventions are effective in preventing post-emergency suicide saves lives and are cost-effective relative to usual care. Press release: http://bit.ly/2xfZrtY
  • Also on September 15, Sen. Toomey (R-PA wrote a letter to HHS OIG requesting that it investigate suspected under-the-table kickbacks by Medicaid-reimbursed outpatient facilities to ‘recovery homes’  in Philadelphia. Press release: http://bit.ly/2xfz6ff Letter: http://bit.ly/2xfV1Dr

 Prescription Drugs –

  • On September 12, FDA Commissioner Gottlieb penned a blog post highlighting the FDA’s progress in advancing the goals of the Orphan Drug Act through its Orphan Drug Modernization Plan. Blog post: http://bit.ly/2xcLWeg
  • On September 13, House Energy & Commerce Committee, Subcommittee on Health released draft legislation to create a user fee program for over-the-counter drugs. Press release: http://bit.ly/2xdfc4K Draft bill: http://bit.ly/2xdvLxB
  • Also on September 13, Reps Doggett (D-TX) led a group of 8 Democrats in a letter to CMS Administrator Verma requesting information on CMS’ new outcome-based payment approach for a new chimeric antigen receptor treatment. Press release with text of letter: http://bit.ly/2xdyS8N
  • On September 14, the FDA announced rates for biosimilar and prescription drug user fees for FY 2018. Notices: http://bit.ly/2vYImS3 and http://bit.ly/2vZ3Yhb
  • Also on September 14, the FDA announced the approval of the first biosimilar for the treatment of cancer. Press release: http://bit.ly/2vZ5tM9

Health IT –

  • On September 12, HHS Office of the National Coordinator for Health IT released a white paper on connecting public health information systems and health information exchange organizations. Report: http://bit.ly/2xd5cZf
  • On September 13, the GAO published a report on the capabilities and challenges of technologies to enable rapid diagnoses of infectious diseases, finding potential benefits, like improved patient health care and management, as well as potential challenges, like lack of patient sample access or reliable genetic databases for developing assays. Report: http://bit.ly/2vZvL19

Veterans Health –

  • On September 12, GAO released a report finding that the Department of Veterans Affairs (VA) is not managing its outgoing mail effectiveness as it lacks key elements of an effective mail management program. Summary with link to report: http://bit.ly/2xcVPZp
  • Also on September 12, VA Office of the Inspector General released a report highlighting concerns regarding the accuracy and timeliness of payments made under the Choice Program, as authorized by the Veterans Access, Choice, and Accountability Act. Report: http://bit.ly/2xcUnpY
  • On September 13, VA announced it has awarded $343 million in grants to 288 nonprofit organizations to help homeless and at-risk veterans and families. Press release: http://bit.ly/2vZ4bRr
  • Also on September 13, VA announced the opening of a Veterans Crisis Line call center in Topeka, Kansas, the third call center it has opened nationwide. Press release: http://bit.ly/2xcWo5t
  • On September 15, VA released findings from an analysis of Veteran suicide data for 50 states, Puerto Rico and the District of Columbia. Press release: http://bit.ly/2xdFRyx Report: http://bit.ly/2xdv5YY

 Misc. –

  • On September 12, Congressional Diabetes Caucus Co-Chairs Degette (D-CO) and Reed (R-NY) sent a letter to House Speaker Ryan (R-WI) and Minority Leader Pelosi (D-CA) urging the immediate reauthorization of the Special Diabetes Program, which provides federal funding for diabetes research and prevention and management programs for high-risk populations. Press release: http://bit.ly/2xdDvzD Letter: http://bit.ly/2xcKxV4
  • Also on September 12, the U.S. Census Bureau published a report on income, poverty, and health insurance coverage in the United States in 2016, finding that the percentage of people without health insurance coverage for the entire 2016 calendar year was 8.8 percent, down from 9.1 percent in 2015. Report: http://bit.ly/2wq7OPH
  • Also on September 12 GAO released a report describing CMS contracting data, noting that CMS increased its contracting obligations by about 40 percent between fiscal years 2012 and 2016, largely due to the implementation of the ACA. Summary with link to report: http://bit.ly/2xdZczu
  • On September 15, the Centers for Disease Control and Prevention (CDC) published a report assessing hospital emergency department response to potentially infectious diseases, finding that the majority of drills were completed successfully but approximately 40 percent of hospitals failed at least one drill. Report: http://bit.ly/2eZFzB2
  • Also on September 15, the CDC published a report finding that the prevalence of certain chronic diseases and conditions, health risk behaviors, and use of preventive health services varies among states and territories, highlighting the need for continued monitoring of health status, health care access, health behaviors, and chronic diseases and conditions at state and local levels. Report: http://bit.ly/2f0iCxI
  • Also on September 15, Senate Finance Committee Chair Hatch (R-UT) sent a letter to HHS Secretary Price requesting further details about the HHS OIG’s report concerning potential abuse or neglect of Medicare beneficiaries in federally-funded skilled nursing facilities. Press release: http://bit.ly/2xd99NF Letter: http://bit.ly/2xcK4lJ
  • On September 17, HHS announced the activation of the National Disaster Medical System Definitive Care Reimbursement Program, which reimburses medical facilities and hospitals for the definitive medical care costs of patients medically evacuated following disasters. Press release: http://bit.ly/2xdQu4j