What’s Ahead: This Week

Hearings/Markups –

  • Tuesday, June 26
    • House Veterans Affairs Committee, “VA Electronic Health Record Modernization: The Beginning of the Beginning.”
    • House Appropriations Committee, “Markup of FY19 Labor-HHS-Education Appropriations Bill.”
    • Senate Appropriations Committee, Subcommittee on Labor-HHS-Education, “Markup of FY19 Labor-HHS-Education Appropriations Bill.”
    • Senate Finance Committee, “Prescription Drug Affordability and Innovation: Addressing Challenges in Today’s Market.”
    • Senate Judiciary Committee, “Survivor’s Bill of Rights: Implementation and Next Steps.”
    • Senate HELP Committee, “Markup of S. 3029, S. 1222, S. 808, S. 3039, S. ___, a bill the reauthorize the Carl D. Perkins Career and Technical Education Act, and Nominations.”
  • Wednesday, June 27
    • House Oversight and Government Reform Committee, “Examining the Administration’s Government-Wide Reorganization Plan.”
    • House Veterans Affairs Committee, Subcommittee on Health, “Markup of Pending Legislation.”
    • Senate Veterans Affairs Committee, “Pending Nomination: Secretary of Veterans Affairs.”
    • Senate HELP Committee, “How to Reduce Health Care Costs: Understanding the Cost of Health Care in America.”
    • Senate Homeland Security and Governmental Affairs Committee, “Medicaid Fraud and Overpayments: Problems and Solutions.”
  • Thursday, June 28
    • Senate Appropriations Committee, “Markup of FY19 Defense Appropriations Bill and FY19 Labor-HHS-Education Appropriations Bill.”

 Notable Policy Events –

  • Monday, June 25
    • National Comprehensive Cancer Network, “Oncology Policy Summit.” Additional information: https://bit.ly/2rxQSqd
    • American College of Rheumatology and National Psoriasis Foundation: “Medicare Access Challenges in the Chronic Disease Community: The Patient Perspective.”
  • Tuesday, June 26
    • Alliance for Health Policy, “Congressional Briefing: Understanding the VA Mission Act.” Additional information: https://conta.cc/2I8w4M1
    • National Pharmaceutical Council, “Webinar: Barriers to Paying for Value.” Additional information: https://bit.ly/2K8AOTH
    • The Heritage Foundation, “The Importance of Free-Market Principles in American Healthcare.” Additional information: https://herit.ag/2KhOCyU
  • Wednesday, June 27
    • Food and Drug Administration (FDA), “FDA Online Opioid Summit: Reducing Availability of Illicit Opioids Online.” Additional information: http://bit.ly/2Ko2BTT
  • Friday, June 29
    • Alliance for Health Policy, “Congressional Briefing: Health Care Costs in America.” Additional information: https://conta.cc/2K9TJRm


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

 Administration –

  • On June 21, the Trump Administration released a plan to reorganize various areas of the federal government, entitled “Delivering Government Solutions in the 21st Century: Reform Plan and Reorganization Recommendations.” Press release: https://bit.ly/2yvBAZL Plan: https://bit.ly/2MNCtQA

Budget and Appropriations –

  • On June 21, the House Budget Committee approved by a vote of 21-13 the Fiscal Year 2019 House Budget Resolution, which includes reconciliation language that instructs 11 committees of jurisdiction to pass legislation cutting $302 billion from mandatory programs and to repeal the ACA. The resolution now moves to the full House for consideration. Press release: http://bit.ly/2Kbj36o Fact sheet: http://bit.ly/2KbYnuU Budget Resolution: http://bit.ly/2IgTqiP Legislative Text: http://bit.ly/2KcnKgr

Legislative Activity –

  • On June 19, Rep. Donovan (R-NY) introduced H.R. 6151, which would require the Department of Veterans Affairs (VA) to alert veterans of and hold public forums related to planned service changes or closures at VA Medical Centers. Press release: https://bit.ly/2tjU75r
  • On June 20, Reps. O’Halleran (R-AZ), Knight (R-CA), and Moulton (D-MA) introduced the Combatting Opioid Misuse Before Addiction for our Troops (COMBAT) Act (H.R. 6165), which would implement a seven day first-fill limit for opioid prescriptions in the TRICARE program. Press release: https://bit.ly/2IdZnNC
  • On June 21, Rep. Cohen (D-TN) introduced the Nationally Enhancing the Wellbeing of Babies through Outreach and Research Now (NEWBORN) Act (H.R. 6174), which would create infant mortality-focused pilot programs in the highest-risk areas of the country. Press release: https://bit.ly/2JZqOAn
  • Also on June 21, Rep. Barragán introduced the Mental Health Care for Children Inhumanely Separated from Parents by the Federal Government Act (H.R. 6180), which would require every child separated from their parents to undergo an assessment by a mental health professional within 24 hours of separation. Press release: https://bit.ly/2MO4OWX
  • Also on June 21, Sen. McCaskill (D-MO) introduced the Pharmaceutical Origin Transparency Act (S. 3105), which would require pharmaceutical companies to display on their website the country of origin of all active pharmaceutical ingredients in the drugs they manufacture. Press release: https://bit.ly/2KchUeT
  • Also on June 21, Sens. Casey (D-PA), Kaine (D-VA), Nelson (D-FL), Hassan (D-NH), Smith (D-MN), Blumenthal (D-CT) and Klobuchar (D-MN) introduced the Higher Education Mental Health Commission Act (S. 3106), which would establish a national commission to study the mental health concerns facing students at colleges and universities in the United States. Press release: https://bit.ly/2ti8CaF
  • Also on June 21, Sen. Harris (D-CA) introduced the Combat Valley Fever Act (S. 3114), which would establish a national registry to track cases of coccidioidomycosis. Press release: https://bit.ly/2yB0qri
  • On June 22, the House passed by a vote of 396-14 the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (H.R. 6), which includes dozens of bills passed by the House over the last two weeks that seek to provide for opioid use disorder prevention, recovery, and treatment. The bill now moves to the Senate for consideration. Press releases: http://bit.ly/2Kl4Q6P and http://bit.ly/2KjH9vY and https://bit.ly/2M816Gj and http://bit.ly/2K7U0kF Summary: http://bit.ly/2InoGfS Bill text: http://bit.ly/2InFp2O

 ACA Implementation –

  • On June 18, a group of nine bipartisan governors released a statement urging the Administration to reverse their efforts to change ACA policy for those with pre-existing conditions. Statement: https://bit.ly/2MfD0K5
  • On June 19, Sen. Klobuchar (D-MN) penned a letter to Department of Health and Human Services (HHS) Secretary Azar, calling on him to release and all materials the agency has prepared to prevent health insurance coverage losses and premium increases. Press release with text of letter: https://bit.ly/2tjdQCi
  • Also on June 19, Department of Labor announced a final rule expanding association health plans (AHPs), by allowing greater flexibility for small employers and sole proprietors to band together for the purpose of offering health insurance coverage. Statements from HHS and CMS: https://bit.ly/2MbaUQb and https://go.cms.gov/2tl7LVO Congressional statements from: Senate HELP Committee Chair Alexander (R-TN) and Ranking Member Murray (D-WA): https://bit.ly/2K6N5IF and https://bit.ly/2lmqIUv  Senate Finance Committee Ranking Member Wyden (D-OR): https://bit.ly/2MKd5ej House Energy & Commerce Majority Leadership: https://bit.ly/2K64JMm House Energy & Commerce, Education, and Ways & Means Committees Ranking Members: https://bit.ly/2tmj7sG DOL Press release: https://bit.ly/2JSZxiM Final rule: https://bit.ly/2KcZqxU
  • On June 20, Attorneys General from New York and Massachusetts announced their intent to sue the Administration over the Department of Labor’s final rule on association health plans. Press release: https://on.ny.gov/2JR0LuZ

 Medicare & Medicaid –

  • On June 18, Senate Budget Committee Chair Enzi (R-WY) led a group of nine Republican committee members in a letter to HHS Secretary Azar, urging the Department to take steps to reduce improper payments in Medicare and Medicaid. Press release: https://bit.ly/2MJe0vN Letter: https://bit.ly/2MJdoGo
  • On June 20, Sens. Klobuchar (D-MN) and Smith (D-MN) penned a letter to CMS Administrator Verma requesting information and resources from CMS about Medicare changes taking effect this fall. Press release with letter text: https://bit.ly/2tewAUg
  • On June 20, CMS issued a request for information (RFI) soliciting input on how to change physician self-referral rules, known as the Stark Law, to help the agency better understand provider concerns and target its regulatory efforts to address those concerns. Comments are due by August 24. Blogpost: https://bit.ly/2K9oMK1 RFI: https://bit.ly/2Keh411
  • Also on June 20, CMS released a guidance to bring states’ attention to section 12005 of the 21st Century Cures Act, which pertains to Medicaid reimbursement for early and periodic screening, diagnostic, and treatment (EPSDT) services to children in institutions for mental diseases (IMD). Guidance: https://bit.ly/2I913rv
  • On June 22, Michigan Governor Snyder signed into law S.B. 897, which would instruct the state to submit a section 1115 demonstration waiver from CMS to impose work requirements for the expansion population. Press release: http://bit.ly/2KpffSe

 New Payment and Delivery System Reforms –

  • On June 19, CMS posted slides and a frequently asked questions document in relation to Maryland’s Total Cost of Care (TCOC) Model, which sets a per capita limit on Medicare total cost of care in the state. Slides: https://bit.ly/2M4Hd35 FAQ: http://bit.ly/2K7dBph
  • Also on June 20, CMS released the communications guidance document for year three participants of the Medicare Advantage Value-Based Insurance Design (VBID) Model. Guidance: https://bit.ly/2MJk87h
  • On June 22, CMS released the fourth evaluation report and accompanying appendices for Models 2-4 of the Bundled Payments for Care Improvement initiative. Report: http://bit.ly/2KewR3r Appendices: http://bit.ly/2K6oacc
  • Also on June 22, CMS posted the second annual report for the State Innovation Models initiative for Round Two of the test awards. Report: http://bit.ly/2KeoN2D
  • Also on June 22, CMS released the third annual report for Round Two of the Health Care Innovation Awards. Report: http://bit.ly/2K7e0bh

Mental Health and Substance Use –

  • On June 19, National Institutes of Health (NIH) published a study finding that methadone and buprenorphine reduce the risk of death after an opioid overdose. The research also confirmed that these effective treatments are underutilized. Press release: https://bit.ly/2JPOpUb Study: https://bit.ly/2lnQs3a
  • On June 21, Substance Abuse and Mental Health Services (SAMHSA) announced that it is accepting applications for up to $50 million in Tribal Opioid Response Grants. Press release: https://bit.ly/2lt3JqW

Drug Prices and Regulation

  • On June 18, Sens. Grassley (R-IA) and Warren (D-MA) penned a letter to Food and Drug Administration (FDA) Commissioner Gottlieb to reiterate the importance of including medical device identifiers on the updated Medicare claim form. Press release: https://bit.ly/2JRBhhb Letter: https://bit.ly/2td5DAt
  • On June 19, FDA released a statement on the agency’s response to ongoing drug shortages for critical products such as IV fluids, injectable opioid analgesics, and EpiPens, which was made in response to a June 15 letter signed by 29 bipartisan Senators asking the agency to convene its Drug Shortages Task Force and develop a policy recommendation by no later than the end of 2019. Letter: https://bit.ly/2Ka28EF Statement: https://bit.ly/2yw0gkG
  • On June 21, FDA announced the availability of a draft guidance for industry entitled “Prescription Drug User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.” Comments are due by August 20. Draft guidance: https://bit.ly/2tge6Ts
  • Also on June 21, FDA expanded the approval of automated insulin delivery and monitoring systems for use in younger pediatric patients. Press release: https://bit.ly/2Ma8sZS
  • Also on June 21, FDA approved the first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes. Press release: https://bit.ly/2MLGViB
  • On June 22, Senate Judiciary Committee Chair Grassley (R-IA) and Sen. Klobuchar (D-MN) sent a letter to the Federal Trade Commission, urging it to examine whether makers of biologic medicines are using strategies like “pay for delay” to hinder or delay biosimilars from entering the market. Press release with text of letter: http://bit.ly/2Kae7m8

Military & Veterans’ Health –

  • On June 18, Department of Veterans Affairs (VA) released its National Suicide Data Report, which showed that the average number of veterans who died by suicide each day has remained consistent during the period between 2005 and 2015. Press release: https://bit.ly/2K35Xv7 Report: https://bit.ly/2xtDWpp
  • Also on June 18, Sens. Tester (D-MT), Blumenthal (D-CT), Baldwin (D-WI), and Brown (D-OH) penned a letter to the VA Inspector General calling for an investigation into VA’s implementation of the VA Accountability and Whistleblower Protection Act. Press release: https://bit.ly/2lp9ciy Letter: https://bit.ly/2ttClwF
  • On June 20, House Veterans Affairs Committee Chair Roe (R-TN) and Ranking Member Walz (D-MN) announced the creation of a new subcommittee to focus on the EHR Modernization program and other major technology projects at the VA. The subcommittee will be discussed and considered by the full committee at a business meeting on July 12, 2018. Press release: https://bit.ly/2IhrUS8
  • On June 21, Sen. McCain (R-AZ) sent a letter to VA Acting Secretary O’Rourke expressing concern about the VA’s annual nursing home ratings. Press release: https://bit.ly/2tkmEJ5 Letter: https://bit.ly/2MPCFic
  • Also on June 21, VA announced specific recommendations in the Administration’s government reform and realignment plan. The proposed recommendations seek to modernize the VA by reducing bureaucracy, increasing accountability, and improving delivery of services. Press release: https://bit.ly/2K47CSd
  • Also on June 21, U.S. Government Accountability Office (GAO) released a report showing that steps have been taken to improve physician staffing, recruitment, and retention at the VA, but challenges remain. Summary: https://bit.ly/2yxROl2 Report: https://bit.ly/2yxGMMF

 Health IT –

  • On June 18, an HHS Administrative Law Judge ruled that the University of Texas MD Anderson Cancer Center violated the HIPAA Privacy and Security rules, requiring the medical center to pay $4,348,000 in civil penalties to the HHS Office of Civil Rights. Press release: https://bit.ly/2t6IAHA
  • On June 19, HHS Office of the National Coordinator for Health IT (ONC) posted a blog on the office’s efforts to advance interoperability. Blog: https://bit.ly/2K9IPLm
  • On June 20, CMS announced that it is hosting the first-ever Blue Button 2.0 Developer Conference on August 13, 2018 in Washington, D.C. Press release: https://go.cms.gov/2K2kcNu
  • On June 21, CMS announced the launch of the Data Element Library (DEL) to serve as a comprehensive, electronic, distributable, and centralized resource of CMS patient assessment instrument content for the public. Press release: https://go.cms.gov/2MLmWk6 Fact sheet: https://go.cms.gov/2K1VX6j Library: https://bit.ly/2IgJply

 Misc. –

  • On June 18, Centers for Disease Control and Prevention (CDC) released data on obesity, alcohol consumption, and general health status, finding that smoking rates among adults in the United States have dropped to record low levels, declining from 16 percent in 2016 to about 14 percent in 2017. Link: https://bit.ly/2t7i3Kc
  • On June 20, NIH released a study finding that psychotherapeutic intervention shows promise for treating depression in preschool-aged children. Press release: https://bit.ly/2MLoOtm Study: https://bit.ly/2loibAH
  • On June 21, House Energy & Commerce Leadership sent letters to ten state hospital associations regarding the accessibility of rape kits. Press release with links to letters: https://bit.ly/2lpZjRA
  • Also on June 21, CDC released a report showing that tobacco-free policies are on the rise across colleges and universities in the United States, many of which include e-cigarettes and hookahs. Press release: https://bit.ly/2luhndE Report: https://bit.ly/2MNtvTj
  • Also on June 21, NIH published a study of new evidence that viruses may play a role in Alzheimer’s disease. Press release: https://bit.ly/2tfOXs5 Study: https://bit.ly/2MQxQVF
  • On June 22, CDC released a report on self-reported concussions from playing a sport or being physically active among high school students in the United States in 2017. Findings suggest that students who played on a sports team had a much higher risk for one or more concussions than did students who did not play on a team. Report: https://bit.ly/2IfQiUq
  • Also on June 22, Senate HELP Committee Ranking Member Murray (D-WA) led a group of 11 Senate democrats in a letter to the GAO, requesting that the office study state-based efforts to combat maternal mortality. Press release: http://bit.ly/2KljHOA Letter: http://bit.ly/2Km4LQE