Health Policy Update 3-20-17


What’s Ahead: This Week in Health Care Policy

Hearings/Markups

  • Monday, March 20
    • House Rules Committee, “H.R. 372 – Competitive Health Insurance Reform Act of 2017 and H.R. 1101 – The Small Business Health Fairness Act of 2017.”
  • Tuesday, March 21
    • Senate HELP Committee, “FDA User Fee Agreements: Improving Medical Product Regulation and Innovation for Patients Part I.”
    • House Energy & Commerce Committee, Subcommittee on Oversight & Investigations, “Fentanyl: The Next Wave of the Opioid Crisis.”
  • Wednesday, March 22
    • House Energy & Commerce Committee, Subcommittee on Health, “Examining the FDA’s Prescription Drug User Fee Program.”
    • House Oversight & Government Reform Committee, Subcommittee on Health Care, Benefits and Administrative Rules, “Examining the Impact of Voluntary Restricted Distribution Systems in the Pharmaceutical Supply Chain.”

Notable Policy Events

  • Monday, March 20
    • HHS Office of the National Coordinator for Health IT (ONC), “2017 Interoperability in Action Day.” Additional information: http://bit.ly/2mXkKvw
    • National Academy of Social Insurance, “Medicaid’s Role in Prevention, Population Health, and Building a Culture of Health at the State Level.” Additional information: http://bit.ly/2mQEn6l
  • Tuesday, March 21
    • POLITICO, “Digital Health Pioneer: Lessons from the VA.” Additional information: http://politi.co/2mXbaJ3
    • National Academy of Medicine, “Vital Directions for Health and Health Care: Priorities from a National Academy of Medicine Initiative.” Additional information: http://bit.ly/2mXf7gI
  • Wednesday, March 22
    • CMS, “Meeting of the Advisory Panel on Outreach and Education.” Additional information: http://bit.ly/2mXbV4T
    • CMS and Centers for Disease Control and Prevention (CDC), “Roles of CMS and CDC in the Medicare Diabetes Prevention Program Expansion.” Additional information: http://bit.ly/2mX7XsS
  • Thursday, March 23
    • HHS Agency for Healthcare Research and Quality (AHRQ), “Effective Design and Use of Patient Portals and their Impact on Patient-Centered Care.” Additional information: http://bit.ly/2mXgtIh
    • Cato Institute, “What Voters Hate about Obamacare: Public Polling and the Affordable Care Act’s Impact on Healthcare Quality.” Additional information: http://bit.ly/2mXfUhL 

Weekly Wrap Up: Notable Health Care Developments From Last Week

Administration

  • On March 13, Senate approved by a vote of 55-43 the nomination of Seema Verma to be Administrator of CMS. HHS Press release: http://bit.ly/2mXgjAZ
  • Also on March 13, President Trump signed an Executive Order directing the Director of the Office of Management and Budget (OMB) to propose a plan to reorganize governmental functions and eliminate unnecessary agencies, components of agencies, and agency programs through the solicitation of public comments and proposals from executive agencies. Executive Order: http://bit.ly/2mXnlpc
  • On March 17, Senate Finance Committee Ranking Member Wyden (D-OR) sent a letter to HHS Acting General Counsel Davis requesting information about how the agency will ensure CMS Administrator Verma is in compliance with her ethics agreements not to work directly on matters relating to the seven states with which she has previously done consulting related to Medicaid. Press release: http://bit.ly/2n0kn1f Letter: http://bit.ly/2n0mOAU

Fiscal Year 2018 President’s Budget

  • On March 15, Senate HELP Committee Ranking Member Murray (D-WA) sent a letter to President Trump urging him to uphold women’s reproductive rights and access to reproductive healthcare in his first budget. Press release: http://bit.ly/2n5Zyne Letter: http://bit.ly/2n63gxd
  • On March 16, President Trump released a blueprint for the fiscal year 2018 budget, which proposes to cut funding to HHS by $15 billion, a 17.9% decrease from the 2017 annualized continuing resolution level. HHS Press release: http://bit.ly/2myj4pe Budget Blueprint: http://bit.ly/2n6PYQV

Legislative Activity

  • On March 15, Senate Finance Committee Ranking Member Wyden (D-OR) and Sens. Brown (D-OH) and Heitkamp (D-ND) introduced the Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act (S. 637), which would require pharmacy benefit managers (PBMs) in Medicare to disclose their aggregate rebates provided by drug manufacturers, as well as the amount of those rebates that are passed on to health plans. Press release: http://bit.ly/2n46e5b Summary: http://bit.ly/2n4dazo Bill text: http://bit.ly/2n4eTon
  • Also on March 15, Senate HELP Committee Ranking Member Murray (D-WA) and 30 cosponsors introduced the Healthy Families Act (S. 636), which would allow workers to earn paid sick leave so that they can address their own health needs and the health needs of their families. Rep. DeLauro (D-CT) and 107 cosponsors introduced a companion bill in the House (H.R. 1516). Press releases from Sen. Murray and Rep. DeLauro: http://bit.ly/2n62BvJ and http://bit.ly/2n62Gj1 Summary: http://bit.ly/2n5V5kj
  • Also on March 15, Sens. Durbin (D-IL), Brown (D-OH), Markey (D-MA), Cardin (D-MD), and Casey (D-PA) introduced the American Cures Act (S.640), which would prioritize funding for an expanded and sustained national investment in biomedical research. Press release: http://bit.ly/2mQnZCN
  • Also on March 15, Sen. Portman (R-OH) and Kaine (D-VA) introduced the Early Hearing Detection and Intervention Act (S. 652), which would reauthorize a program for early detection, diagnosis, and treatment regarding deaf and hard-of-hearing newborns, infants, and young children. Reps. Guthrie and Matsui (D-CA) introduced a companion bill in the House (H.R. 1539). Sen. Portman and Rep. Guthrie Press releases: http://bit.ly/2nAuQA7 and http://bit.ly/2nAB1Ev
  • Also on March 15, Sen. Thune (R-SD) intruded the Veterans Choice Program Resolution Act (S. 663), which would establish a Choice Program Ombudsman within the Office of Inspector General of the Department of Veterans Affairs to manage complaints regarding the provision of hospital care and medical services under 101 of the Veterans Access, Choice, and Accountability (CHOICE) Act of 2014. Press release: http://bit.ly/2n6UMFU
  • Also on March 15. Reps. Walberg (R-MI) and Dingell (D-MI) introduced Jessie’s Law (H.R. 1554), which would include information concerning a patient’s opioid addiction in certain medical records. Sens. Manchin (D-WV) and Capito (R-WV) previously introduced a companion bill in the Senate (S. 581). Press release: http://bit.ly/2n4rvvr
  • On March 16, Rep. Payne (D-NJ) and 14 cosponsors introduced the Donald Payne Sr. Colorectal Cancer Detection Act of 2017 (H.R. 1578), which would provide coverage under the Medicare program for FDA-approved qualifying colorectal cancer screening blood-based tests. Press release: http://bit.ly/2nAsgds
  • Also on March 16, Rep. Serrano (D-NY) introduced the Protecting Our Kids Act of 2017 (H.R. 1586), which would ensure that liquid and over-the-counter medications are packaged with appropriate dosage delivery devices and, in the case of such medications labeled for pediatric use, appropriate flow restrictors. Press release: http://bit.ly/2n6PfiI
  • Also on March 16, Reps. Thompson (D-CA) and Eshoo (D-CA) introduced the Fair Access to Health Care Act (H.R. 1589), which would adjust the phase-out of insurance tax credits for geographic variations in the cost-of-living. Press release: http://bit.ly/2nAsCAO
  • Also on March 16, Rep. Yoho (R-FL) introduced the Holding Health Insurers Harmless Act (H.R. 1592), which would remove penalties for health insurers under the ACA. Press release: http://bit.ly/2n6Y23V

ACA Repeal and Replace

  • On March 13, Congressional Budget Office (CBO) released its analysis of the American Health Care Act, projecting that the legislation would reduce insurance coverage by 24 million by 2026 and would reduce the federal deficit by $337 billion over that period. Press releases from Committees on Energy & Commerce and Ways & Means: http://bit.ly/2mXntoK http://bit.ly/2mXlpwW Press release from Ranking Members Pallone (D-NJ) and Neal (D-MA): http://bit.ly/2mXkEE8 Press release from HHS Secretary Price: http://bit.ly/2mXaLWX Report: http://bit.ly/2mXnjh8
  • On March 14, HHS released a statement describing how the American Health Care Act will restore, protect, and preserve the doctor-patient relationship. Press release: http://bit.ly/2mTED6l
  • On March 15, House Minority Leader Pelosi (D-CA) sent a letter to House Majority Leader Ryan (R-WI) warning that any changes Republicans may make to the AHCA before it advances to a House vote should be followed by an updated score from the Congressional Budget Office (CBO) before being voted on. Press release: http://bit.ly/2mNYzpC Letter: http://bit.ly/2mOmbdG
  • On March 16, House Budget Committee approved the American Health Care Act by a vote of 19-17. The bill now moves to the Rules Committee for consideration before advancing to the House Floor. Press release: http://bit.ly/2n4ciKN

Marketplaces

  • On March 13, HHS Secretary Price sent a letter to governors encouraging the use of Section 1332 State Innovation Waivers, which can be implemented starting in 2017 to change major elements of the ACA that apply to private insurance coverage and the marketplace. Press release and letter: http://bit.ly/2nG7Mzj and http://go.cms.gov/2ngMPyN
  • On March 15, CMS published a final enrollment report for the 2017 Open Enrollment period, finding that approximately 12.2 million consumers selected or were re-enrolled in a Marketplace plan across the federally-facilitated and state-based Marketplaces. Report: http://go.cms.gov/2mNY68n
  • On March 17, HHS Office of the Inspector General (OIG) released a report finding that the federal health insurance Marketplace is unable to calculate the total number of applicants with data inconsistencies during the first open enrollment period because the data cannot uniquely identify individuals. Summary with link to report: http://bit.ly/2n6RuT4

Medicare

  • On March 14, HHS Office of Inspector General (OIG) published a report finding that hospitals nationwide generally did not comply with Medicare requirements for billing outpatient right heart catheterizations with heart biopsies. Report: http://bit.ly/2mNn8CQ
  • On March 15, Medicare Payment Advisory Commission (MedPAC) published its March report to Congress on Medicare payment policy, including analyses of payment adequacy in FFS Medicare and a review of Medicare Advantage and Medicare Part D. In the report, MedPAC strongly recommended that Congress act to reform post-acute payment policies. Press release and report: http://bit.ly/2n3jKWR and http://bit.ly/2mNiR28
  • On March 15, CMS announced a new educational initiative called Connected Care, which aims to raise awareness of the benefits of chronic care management services for Medicare beneficiaries and to provide health care professionals with support to implement chronic care management programs. Press release: http://go.cms.gov/2m1j2Kq

Medicaid

  • On March 14, HHS Secretary Price and CMS Administrator Verma sent a letter to governors describing their intention to streamline and expedite the state plan amendment and section 1115 waiver process, and highlighting new opportunities for innovation. Press release and letter: http://bit.ly/2mujKM4 and http://bit.ly/2m18ZVm
  • Also on March 14, Senate Finance Committee Ranking Member Wyden and House Energy & Commerce Committee Ranking Member Pallone (D-NJ) wrote a letter to HHS Secretary Price arguing that HHS does not have the authority to approve Medicaid waivers that would condition eligibility on employment. Press release: http://bit.ly/2n433dA Letter: http://bit.ly/2n46HEi
  • On March 15, the Medicaid and CHIP Payment and Access Commission (MACPAC) published their March report to Congress, which includes recommendations for the future of CHIP, an analysis of disproportionate share hospital (DSH) allotments to states, and monitoring access to care in Medicaid. Summary with link to report: http://bit.ly/2nnuY9w

Health IT

On March 15, U.S. Government Accountability Office (GAO) released a report finding that although HHS has invested significantly in health information technology, relatively few patients electronically access their health information when offered the ability to do so. Summary with link to report: http://bit.ly/2n3iLFZ

Mental Health and Substance Abuse

  • On March 14, Substance Abuse and Mental Health Services Administration (SAMHSA) announced that it is accepting applications for a grant program that aims to increase engagement in care for racial and ethnic minority individuals with substance use disorders and/or mental disorders who are at risk for HIV or are HIV positive and receive treatment. Applications are due by May 3. Press release: http://bit.ly/2myBmXg
  • On March 17, CDC released a report on the characteristics of initial prescription episodes and likelihood of long-term opioid use, finding that the likelihood of chronic opioid use increased with each additional day of medication supplied. Report: http://bit.ly/2n6Ybok 

Misc.

  • On March 13, Senate HELP Committee Ranking Member Murray (D-WA), Sen. Warren (D-MA), House Committee on Energy & Commerce Ranking Member Pallone (D-NJ), and Reps Green (D-TX), and DeGette (D-CO) wrote a letter to HHS Secretary Price and Acting CDC Director Schuchat requesting information on how certain actions by the Trump administration would impact HHS and CDC preparedness for a flu pandemic. Press release: http://bit.ly/2mXiRyH Letter: http://bit.ly/2mXjgBf
  • Also on March 13, CDC announced a potential increased risk of Zika virus transmission for residents in Florida’s Broward and Palm Beach counties since June 15, 2016. Press release: http://bit.ly/2msL7oZ
  • On March 14, Food and Drug Administration (FDA) released a Request for Comments (RFC) on a plan to establish a new Office of Patient Affairs that would centralize its work on patient involvement in the review and approval of drugs and medical devices. Comments are due by June 12. RFC: http://bit.ly/2n6S8A8
  • Also on March 14, FDA released an RFC on a list of more than 1,000 medical devices it is proposing to exempt or partially exempt from the premarket review process in accordance with the 21st Century Cures Act. Comments are due by May 15. RFC: http://bit.ly/2n6Ww1U
  • Also on March 14, researchers at NIH found that a molecule naturally produced by the immune system protects mice and monkeys against the Zika virus. Press release: http://bit.ly/2ntBNmO
  • On March 15, House Committee on Energy & Commerce Chair Walden (R-OR), Vice Chair Barton (R-TX), Oversight & Investigations Subcommittee Chair Murphy (R-PA), and Health Subcommittee Chair Burgess (R-TX) sent a letter to Acting Commissioner of the Food and Drug Administration (FDA) requesting information about the FDA’s actions regarding the ongoing heparin contamination crisis. Press release: http://bit.ly/2n5Vrr0 Letter: http://bit.ly/2n5VTpn
  • Also on March 15, FDA released a notice extending the comment period on draft guidance on considerations in demonstrating biologic interchangeability with a reference product. Comments are now due by May 19. Notice: http://bit.ly/2n6Triw
  • On March 17, HHS released an interim final rule (IFR) delaying the implementation of the 340B drug pricing program ceiling price and manufacturer civil monetary penalties final rule until May 22. Commenters are invited to comment on whether a longer delay of the effective date, to October 1, would be appropriate. Comments are due by April 19. IFR: http://bit.ly/2n0s0EL

 

 

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