What’s Ahead: This Week

Hearings/Markups –

  • Tuesday, April 24
    • Senate HELP Committee, “Markup to Consider the Opioid Crisis Response Act of 2018 (2. 2680), the Over-the-Counter Drug Safety, Innovation, and Reform Act (S. 2315), the Children’s Hospital GME Support Reauthorization Act of 2018 (S. 2597), and the Firefighter Cancer Registry Act (S. 382).”
    • Senate Appropriations Committee, Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies, “FY 19 FDA Budget.”
  • Wednesday, April 25
    • House Energy & Commerce Committee, Subcommittee on Health, Markup of Legislation Relating to the Opioid Crisis.
    • House Ways and Means Committee, Subcommittee on Trade, “The Opioid Crisis: Stopping the Flow of Synthetic Opioids in the International Mail System.”
    • Senate Veterans’ Affairs Committee, “Nomination of Rear Adm. Ronny Jackson to be VA Secretary.”
  • Thursday, April 26
    • House Ways and Means Committee, Subcommittee on Health, “Identifying Innovative Practices and Technology in Health Care.”
    • House Appropriations Committee, Subcommittee on Labor, HHS, Education, and Related Agencies, “FY 2019 Public Witnesses Hearing.”
    • House Veterans Affairs Committee, “Markup of Pending Legislation.”
    • Senate Appropriations Committee, Subcommittee on Defense, “Hearing to Review the Fiscal Year 2019 Funding Request and Budget Justification for the Defense Health Program.”

 Notable Policy Events –

  • Monday, April 23 – Wednesday, April 25
    • National Council for Behavioral Health, “Annual Conference.” Additional information: https://bit.ly/2FnZepD
  • Wednesday, April 25
    • CMS, “Forum on Opioids: Strategies and Solutions for Minority Communities.” Additional information: http://bit.ly/2HJKHt6
    • National Academy of Medicine, “Improving Care for High-Need Patients: A Webinar Series.” Additional information: https://bit.ly/2qEm4DI
    • Network for Excellence in Health Innovation (NEHI), “Health Care Without Walls: Forging a System of More Distributed Care.” Additional information: https://bit.ly/2qN5lOP
    • Roll Call Live, “Patient-Focused Health: A Conversation on Access and Affordability.” Additional information: https://bit.ly/2q6wRWQ
  • Thursday, April 26 – Friday, April 27


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

 Appointments –

  • On April 18, HHS Secretary Azar announced the appointment of James Parker to be Senior Advisor to the Secretary for Health Reform and Director of the Office of Health Reform at HHS. Mr. Parker will lead initiatives addressing the cost and availability of health insurance. Press release: https://bit.ly/2HgHlul

Legislative Activity –

  • On April 16, House Veterans Affairs Committee Chair Roe (R-TN), Ranking Member Walz (D-MN), and Rep. Correa (D-CA) introduced the VA Medicinal Cannabis Research Act of 2018 (H.R. 5520), which would authorize the VA to conduct and support research on the efficacy and safety of medical cannabis. Press release: https://bit.ly/2F3vFsM Text: https://bit.ly/2vvbnsS
  • Also on April 16, Reps. Hartzler (R-MO), Correa (D-CA), and Bost (R-IL) introduced the VA Hiring Enhancement Act (H.R. 5521), which would establish measures to make VA more competitive in hiring physicians and health care providers. Press release: https://bit.ly/2HObm5N Text: https://bit.ly/2HAW4nj
  • Also on April 16, Senate Finance Committee Chair Hatch (R-UT), and Sens. Bennet (D-CO), Donnelly (D-IN), and Young (R-IN) introduced the Advancing Innovation in Alternative Pain and Addiction Therapies Act (S. 2669), which would clarify the Advancing Breakthrough Therapies for Patients Act of 2012 to help bring novel, non-opioid alternative drugs to market more quickly. Press release: https://bit.ly/2HTbEZj Text: https://bit.ly/2HiXKSQ
  • Also on April 15, Sens. Blunt (R-MO) and King (I-VT) introduced the Simplifying Technical Aspects Regarding Seasonality (STARS) Act (S. 2670), which would simplify the treatment of seasonal positions for the purposes of the employer shared responsibility requirement. Press release: http://bit.ly/2qQXWP0
  • Also on April 16, Sens. Cassidy (R-LA) and Murphy (D-CT) introduced the Saving Lives Through Proper Notification of Overdoses Act (S. 2676), which would permit certain disclosures of health information during emergencies, including overdoses. Press release: https://bit.ly/2qLKR9F
  • Also on April 16, Senate Finance Committee Chair Hatch (R-UT), and Sens. Kaine (D-VA) and Warren (D-MA) introduced the Ensuring Access to Quality Recovery Living Act (S. 2678), which would give states the resources and guidelines necessary to ensure recovery homes provide a safe space for recovery. Press release: https://bit.ly/2K1azix Text: https://bit.ly/2HBudDj
  • Also on April 16, Senate HELP Committee Chair Alexander (R-TN) and Ranking Member Murray (D-WA) introduced the Opioid Crisis Response Act of 2018 (S. 2680), which is comprised of forty different proposals to help the Departments of Education, Labor, and HHS to address the opioid crisis. Press release: https://bit.ly/2JdXsJN Text: https://bit.ly/2HJTQPU
  • On April 17, Reps. Buchanan (R-FL) and Murphy (D-FL) introduced the Opioid Emergency Response Act (H.R. 5531), which would provide for a comprehensive, multifaceted approach to preventing and treating opioid addiction. Press release: http://bit.ly/2HESwjU
  • Also on April 17, Sens. Rubio (R-FL), Nelson (D-FL), Stabenow (D-MI), and Cornyn (R-TX) introduced S. 2690, which would end an ACA provision which prohibits hospitals from contesting Medicare Disproportionate Share Hospital (DSH) payments once CMS has rendered a decision. Press release: https://bit.ly/2JbxFSg Text: https://bit.ly/2F3MmnS
  • Also on April 17, Sen. Sanders (I-VT) introduced the Opioid Crisis Accountability Act of 2018 (S. 2691), which creates criminal liability for drug company executives for their role in creating and exacerbating the opioid epidemic. Press release: https://bit.ly/2qPfGtv Text: https://bit.ly/2vv5dJb
  • Also on April 17, Sens. Klobuchar (D-MN) and Young (R-IN) introduced the Department of Veterans Affairs Oversight Enhancement Act of 2018 (S. 2656), which would increase Congressional oversight of the VA in collaboration with GAO. Press release: https://bit.ly/2qI4pMj Text: https://bit.ly/2qL80ZY
  • On April 18, Rep. Knight (R-CA) introduced H.R. 5546, which would authorize the use of certain Department of Defense funds for combating opioid trafficking and abuse in the United States. Press release: https://bit.ly/2F3bQCd
  • Also on April 18, Rep. Jenkins (R-WV) introduced the Protecting Neonatal Abstinence Syndrome Babies Act (H.R. 5562), which would require HHS to develop a strategy to implement GAO recommendations to treat NAS. Press release: https://bit.ly/2HS6DA8 Text: https://bit.ly/2Hfg6o6
  • Also on April 18, House Energy & Commerce Ranking Member Pallone (D-NJ) and Subcommittee on Health Vice Chairman Guthrie (R-KY) introduced the National Centers of Excellence in Continuous Manufacturing Act of 2018 (H.R. 5568), which would allow FDA to partner with universities to further develop and implement continuous manufacturing technology. Press release: https://bit.ly/2HgJ0nw
  • Also on April 18, Sens. Warren (D-MA) and Capito (R-WV) introduced the Unused Medication Awareness Act (S. 2697), which would require the CDC to advance education and awareness of the risk of unused opioids and of the option to partially fill an opioid prescription. Press release: https://bit.ly/2qJQohe
  • Also on April 18, Sen. Warren (D-MA) introduced the Comprehensive Addiction Resources Emergency (CARE) Act (S. 2700), which would provide emergency assistance to states and local areas affected by the opioid epidemic and to make financial assistance available to states and localities and public or nonprofit entities to provide for the development, organization, coordination, and operation of more effective and cost efficient systems for the delivery of essential services to individuals with substance use disorder and their families. Rep. Cummings (D-MD) introduced companion legislation in the House (H.R. 5545). Press release: http://bit.ly/2HKndV2 One-pager: http://bit.ly/2qQWVGZ Summary: http://bit.ly/2HDbpDV Bill text: http://bit.ly/2qQ1wZO
  • Also on April 18, Sens. Casey (D-PA) and Portman (R-OH) introduced S. 2704, which would provide for the coverage of methadone under Medicare Part B.
  • Also on April 18, Sens. Nelson (D-FL), Brown (D-OH), and Heller (R-NV) introduced S. 2707, which would provide educational resources regarding opioid use and pain management as part of the Medicare & You handbook.
  • Also on April 18, Sens. Merkley (D-OR) and Murphy (D-CT) introduced the Choose Medicare Act (S. 2708), which would establish a Medicare Part E public health plan and reform other provisions of the ACA. Press release: https://bit.ly/2HPn28a Text: https://bit.ly/2qMDgb8
  • On April 19, Senate Majority Leader McConnell (R-KY) and Sen. Casey (D-PA) introduced the Supporting Infant Plans of Safe Care Implementation Act of 2018 (S. 2710), which would provide resources and technical assistance to states to improve treatment and early interventions for pregnant and postpartum women and infants affected by substance use disorder. Press release: https://bit.ly/2K3Za1l
  • Also on April 19, Sens. Hassan (D-NH) and Portman (R-OH) introduced the Enhancing Access to Addiction Treatment Act of 2018 (S. 2711), which would help train more doctors to prescribe medication-assisted treatment (MAT). Press relaese: http://bit.ly/2qP8iz0
  • Also on April 19, Sens. Baldwin (D-WI) and Ernst (R-IA) introduced the Facilitating Accessible Resources for Mental Health and Encouraging Rural Solutions for Immediate Response to Stressful Times (FARMERS FIRST) Act (S. 2712), which would establish a farm and ranch stress assistance network. Press release: http://bit.ly/2qQLoYa Bill text: http://bit.ly/2HGB8er

ACA Implementation and Market Stabilization –

  • On April 18, Sens. Grassley and Ernst (R-IA), and Reps. King, Young, and Blum (R-IA) sent a letter to CMS Administrator Verma urging the agency to repeal guidance that limits state insurance market waivers. Press release: https://bit.ly/2HPPDdI Letter: https://bit.ly/2F3w52o

 Medicaid –

  • On April 17, CMS issued guidance to State Medicaid Directors on the proper start date of an asset transfer penalty period for certain Medicaid applicants who are seeking eligibility for Home and Community-Based Services (HCBS) delivered through 1915(c) waivers. Guidance: https://bit.ly/2qO91Ao
  • On April 18, CMS issued guidance to State Medicaid Directors on the requirements for reuse in Mechanized Claims Processing and Information Retrieval Systems. Guidance: https://bit.ly/2vwErzZ
  • On April 19, House Energy & Commerce Committee Ranking Member Pallone (D-NJ) and all 24 of the committee’s democrats sent a letter to HHS Secretary Azar expressing their concerns with the Department’s recent decision to rescind existing guidance on the rights of Medicaid beneficiaries to receive family planning and preventive care services from their qualified providers of choice. Press release: https://bit.ly/2qMBOpa Letter: https://bit.ly/2F3AXEJ

Mental Health and Substance Abuse –

  • On April 16, CMS released an updated version of the Medicare Part D opioid prescribing mapping tool, which presents geographic comparisons of Medicare Part D opioid prescribing rates. Link: https://go.cms.gov/1l0xlcY
  • On April 17, U.S. Government Accountability Office (GAO) released a report on substance use disorder recover housing prevalence, oversight, and funding. Report: https://bit.ly/2JbmfOo
  • Also on April 17, Sens. Cassidy (R-LA), Alexander (R-TN), Murray (D-WA), Murphy (D-CT), Murkowski (R-AK), and Stabenow (D-MI) sent a letter to the Departments of HHS, Labor, and the Treasury urging them to enforce mental health parity laws. Press release: https://bit.ly/2JbVv0a Letter: https://bit.ly/2vudrBc
  • Also on April 17, Drug Enforcement Administration issued a notice of proposed rulemaking (NPRM) that will affect the limits on annual opioid production in instances where there is reason to believe that the company’s opioids are being diverted for misuse. Comments are due by May 4. Press release: http://bit.ly/2JfrXz4  Attorney General Session’s Remarks: https://bit.ly/2HDSbOs NPRM: http://bit.ly/2vxUbTp
  • On April 18, HHS announced the release of the second installment of the Opioid State Targeted Response (STR) grants, totaling $485 million to continue to combat the opioid crisis. Press release: https://bit.ly/2JbwJxb
  • Also on April 18, Sen. Markey (D-MA) sent a letter to HHS Secretary Azar and Attorney General Sessions seeking additional information on the Administration’s plans to distribute newly-appropriated funding to combat the opioid crisis to the states. Press release: https://bit.ly/2HBqiGB Letter: https://bit.ly/2qLCeff
  • Also on April 18, a group of 16 Senators led by Sens. Stabenow (D-MI) and Peters (D-MI) sent a letter to HHS, urging the agency to take immediate action to reduce the price of naloxone, the opioid overdose reversal drug. Press release with letter text: https://bit.ly/2vvxsHN
  • On April 19, Substance Abuse and Mental Health Services Administration (SAMHSA) announced the availability of up to $47.4 million for Mental Health Awareness Training (MHAT) grants over the next three years. Applications are due on June 8, 2018. Press release: https://bit.ly/2JdW0Hj
  • Also on April 19, HHS announced the launch of a new website to help individuals, public health departments, schools, or community organizations find sources of Naloxone. Press release: http://bit.ly/2vtucN3 Website: http://prevent-protect.org/
  • On April 20, Food and Drug Administration (FDA) released draft guidance intended to aid industry in developing new medications for use in medication-assisted treatment (MAT) for opioid dependence. Comments are due by June 20. FDA Commissioner Gottlieb Statement: http://bit.ly/2JenzAn Press release: http://bit.ly/2J9thn2 Guidance: http://bit.ly/2JaAfbk
  • Also on April 20, FDA released draft guidance outlining the agency’s thinking about drug development and clinical trial design issues relevant to the study of sustained-release “depot” buprenorphine products. Comments are due by June 20. Press release: https://bit.ly/2HCUktC Draft guidance: https://bit.ly/2F3Dmzo Commissioner’s statement: https://bit.ly/2HCevI3

Drugs and Medical Device Regulation

  • On April 16, Sen. Grassley (R-IA) released a letter to HHS Secretary Azar and FDA Commissioner Gottlieb requesting more information on unproven medical procedures that are touted as clinical trials. Press release: https://bit.ly/2vvnsOR Letter: https://bit.ly/2F6Ug08
  • On April 17, FDA Commissioner Gottlieb issued a statement on new efforts to enhance and modernize the agency’s approach to medical device safety and innovation. Statement: https://bit.ly/2qLDwa3
  • Also on April 17, FDA Commissioner Gottlieb testified before the House Appropriations Committee, Subcommittee on Agriculture and Rural Development on the agency’s fiscal year 2019 budget request. Statement: https://bit.ly/2qEwm7K
  • Also on April 17, CMS released an update to a February coverage decision memo for implantable cardioverter defibrillators (ICDs). Memo: https://go.cms.gov/2EFR8Mz
  • Also on April 20, Rep. Maloney (D-NY) sent a letter to Joint Economic Committee Chairman Paulsen (D-MN) requesting that the Committee hold a hearing on anti-competitive practices in the prescription drug market. Press release with full text: https://bit.ly/2F3XJwe

 Veterans’ Health –

  • April 16, Department of Veterans Affairs (VA) announced actions it will take to address challenges and issues identified by the Government Accountability Office (GAO) when it placed VA on its High-Risk List. Press release: https://bit.ly/2JakYqU
  • Also on April 16, VA announced updates and improvements to the Department’s briefing portion of the Transition Assistance Program, which is designed to help service members adjust to civilian life. Press release: https://bit.ly/2Jbih8s Benefits briefing: https://bit.ly/2vu70Oy
  • Also on April 16, House Committee on Veterans Affairs, Subcommittee on Oversight & Investigations Chair Bergman (R-MI) released a letter to the VA urging the Department to remedy ongoing flaws in its Choice Program contracts. Press release: https://bit.ly/2qOr09Z Letter: https://bit.ly/2F3sLEs
  • On April 17, Acting VA Secretary Wilkie visited the National Safety Council’s opioid memorial and delivered remarks on the opioid crisis’ impact on veterans. Press release and transcript: https://bit.ly/2vv1iMy
  • On April 18, VA announced $685 million in funding from Congress to fund several State Veterans Home construction projects through the VA State Veterans Home Construction Grant Program. Press release: https://bit.ly/2HeU0hg

Health IT –

  • On April 20, House Energy and Commerce Committee issued a request for information to gather information on legacy technology challenges and on opportunities, considerations, and suggestions for managing legacy technology. Comments are due by May 31. Press release: http://bit.ly/2JetzZR RFI: https://bit.ly/2K1vkdX

 Misc. –

  • On April 16, National Institutes of Health (NIH) released a report finding that Epstein-Barr virus protein can “switch on” risk genes for autoimmune diseases. Press release: https://bit.ly/2JPeLBV
  • On April 17, HHS Deputy Secretary Hargan held a meeting with attendees from patient advocacy groups to discuss information pertaining to the Department’s priorities. Press release: https://bit.ly/2F3Boij
  • Also on April 17, Agency for Healthcare Research and Quality (AHRQ) released a report on differences in health insurance coverage between part-time and full-time private-sector workers in 2005 and 2015. Report: https://bit.ly/2vyCF1u
  • Also on April 17, Senate Finance Committee Ranking Member Wyden (D-OR) released a report finding that health care companies are mostly using tax breaks for share buybacks rather than lowering prices or investing in better care. Press release: https://bit.ly/2K43CNB Report: https://bit.ly/2HN8aaq
  • On April 18, Sens. Cassidy (R-LA), Bennet (D-CO), Grassley (R-IA), Carper (D-DE), Young (R-IN), and McCaskill (D-MO) announced they received nearly 1,000 pages of feedback from more than 130 groups and individuals in response to their February letter seeking input on measures to improve transparency and lower costs in the health care market. Press release: https://bit.ly/2HfpIeo February letter: https://bit.ly/2oC4tvO
  • On April 19, Health Resources and Services Administration (HRSA) announced that HRSA-funded efforts to combat infant mortality in the U.S. South are improving multiple key indicators. Press release: https://bit.ly/2qLC8nR