What’s Ahead: This Week

Hearings –

  • Tuesday, November 14
    • House Oversight & Government Reform Committee, Subcommittees on Health Care, Benefits, and Administrative Rules and Intergovernmental Affairs, “Regulatory Reform Task Forces Check-In: Part Two.”
    • Senate HELP Committee, “Gene Editing Technology: Innovation and Impact.”
  • Wednesday, November 15
    • Senate HELP Committee, “Encouraging Healthy Communities: Perspective from the Surgeon General.”
    • Senate Appropriations Committee, Subcommittee on Military Construction, Veterans Affairs and Related Agencies, “VA Efforts to Prevent and Combat Opioid Overmedication.”
    • House Committee on Appropriations, Subcommittee on Military Construction, Veterans Affairs and Related Agencies, “Oversight Hearing – Veterans Affairs Electronic Health Record.”

 Notable Policy Events –

  • Monday, November 13
    • The Hill, “The Opioid Crisis: What Can Congress Do? A Conversation with House Committee on Energy & Commerce Chairman Greg Walden (R-OR).” Additional information: http://bit.ly/2iIzlat
    • Alliance for Health Policy, “Navigating Next Steps on Payment Reform.” Additional information: http://bit.ly/2hnxpUx
  • Tuesday, November 14
    • Alliance for Pain Management, “Summit on Balanced Pain Management.” Additional information: http://bit.ly/2iIHDij
    • Politico, “Emerging Health Care Leaders.” Additional information: http://politi.co/2iIWg5s
    • American Telemedicine Association, “Medicaid: Telehealth’s Role in Evolving Healthcare Delivery System Reform.” Additional information: http://bit.ly/2iIzevz
    • Real Clear Politics, “Examining the Pharmaceutical Supply Chain: From Production to Patient.” Additional information: http://bit.ly/2hod9SQ
  • Wednesday, November 15


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

 Legislative Activity –

  • On November 6, Rep. Guthrie (R-KY) and three cosponsors ­introduced the Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer’s Act (H.R. 4256), which would authorize the expansion of activities related to Alzheimer’s disease, cognitive decline, and brain health under the Alzheimer’s Disease and Healthy Aging Program. Sens. Collins (R-ME), Cortez Masto (D-NV), Capito (R-WV), and Kaine (D-VA) introduced a companion bill (S. 2076) in the Senate. Press release: http://bit.ly/2iFgHQO Summary: http://bit.ly/2ArOh45 Bill text: http://bit.ly/2AswBoX
  • On November 7, the House passed by a voice vote the Veteran Urgent Access to Mental Healthcare Act (H.R. 918), which would direct the Secretary of Veterans Affairs to furnish mental health care to certain former members of the Armed Forces who are not otherwise eligible to receive such care. The bill now moves to the Senate for consideration. Press release: http://bit.ly/2zuS8he
  • Also on November 7, the House passed by a voice vote the Veterans E-Health and Telemedicine Support Act of 2017 (H.R. 2123), which would improve the ability of healthcare professionals to treat veterans through the use of telemedicine. The bill now moves to the Senate for consideration. Press release: http://bit.ly/2Atr4ya
  • Also on November 7, the Senate passed by unanimous consent the National Suicide Hotline Improvement Act of 2017 (S. 1015), which would require the Federal Communications Commission to study the feasibility of designating a simple, easy-to-remember dialing code to be used for a national suicide prevention and mental health crisis hotline system. The bill now moves to the House for consideration.
  • Also on November 7, Reps. DeSaulnier (D-CA) and Carter (R-GA) introduced the Empowering Pharmacists in the Fight Against Opioid Abuse Act (H.R. 4275), which would provide for the development and dissemination of programs and materials for training pharmacists, health care providers, and patients on indicators that a prescription is fraudulent, forged, or otherwise indicative of abuse or diversion. Press release: http://bit.ly/2iEercg
  • Also on November 7, Rep. Latta (R-OH) and three cosponsors introduced the Indexing Narcotics, Fentanyl, and Opioids (INFO) Act (H.R. 4284), which would establish a federal coordinator within the Department of Health and Human Services and improve and make available important data on the opioid crisis and the effect of federal efforts to combat the opioid epidemic. Press release: http://bit.ly/2iHDI5p
  • Also on November 7, Sens. Bennet (D-CO), Baldwin (D-WI), Merkley (D-OR), Markey (D-MA), and Franken (D-MN) introduced the LGBT Elder Americans Act (S. 2089), which would provide for equal treatment of LGBT older individuals. Press release: http://bit.ly/2iG2y5T
  • On November 8, the House passed by a vote of 420-0 the Veterans Crisis Line Study Act of 2017 (H.R. 4173), which would direct the Secretary of Veterans Affairs to conduct a study on the Veterans Crisis Line. The bill now moves to the Senate for consideration. Press release: http://bit.ly/2zuS8he
  • Also on November 8, Rep. Bucshon (R-IN) introduced the Protecting Seniors Through Immunization Act of 2017 (H.R. 4297), which would provide information regarding vaccines for seniors as part of the Medicare & You handbook and to ensure that the treatment of cost sharing for vaccines under Medicare Part D is consistent with the treatment of vaccines under Medicare Part B. Sen. Hirono (D-HI) introduced a companion bill (S. 2103) in the Senate. Press release: http://bit.ly/2zwd8nK
  • On November 9, the Senate passed by unanimous consent the State Veterans Home Adult Day Health Care Improvement Act of 2017 (S. 324), which would improve the provision of adult day healthcare services for veterans. The bill now moves to the House for consideration. Press release: http://bit.ly/2ArDcA1
  • Also on November 9, the Senate passed by unanimous consent the Veterans Acquiring Community Care Expect Safe Services Act of 2017 (S. 1153), which would prohibit or suspend certain healthcare providers from providing non-Department of Veterans Affairs healthcare services to veterans. The bill now moves to the House for consideration. Press release: http://bit.ly/2i6WaoI
  • Also on November 9, the Senate passed by unanimous consent the Enhancing Veteran Care Act (S. 1266), which would authorize the Secretary of Veterans Affairs to enter into contracts with nonprofit organizations to investigate medical centers of the Department of Veterans Affairs. The bill now moves to the House for consideration. Press release: http://bit.ly/2AriaRY
  • Also on November 9, Sens. Nelson (D-FL) and Blumenthal (D-CT) introduced the FAIR Heroes Act (S. 2117), which would expand eligibility for the TRICARE program to include certain veterans entitled to benefits under the Medicare program due to conditions or injuries incurred during service in the Armed Forces and to waive the Medicare part B late enrollment penalty for such veterans. Press release: http://bit.ly/2Aq64Zl

 ACA Market Stabilization & Implementation –

  • On November 6, Senate HELP Committee Ranking Member Murray (D-WA) and Sen. Warren (D-MA) sent a letter to HHS Acting Secretary Hargan requesting information about HHS’ decision in January to cut ACA outreach and enrollment activity, which resulted in the loss of $1.1 million, according to an analysis by the HHS Office of Inspector General (OIG). Press release: http://bit.ly/2zvNuiY Letter: http://bit.ly/2zxrdBL
  • On November 7, voters in Maine approved a ballot initiative to expand Medicaid in the state, making Maine the 32nd expansion state. Governor LePage Statements: http://bit.ly/2iHxZNd and http://bit.ly/2zvIbQO
  • On November 8, Congressional Budget Office (CBO) released an estimate finding that repealing the individual mandate would reduce the federal deficit by $338 billion from 2018 to 2027 and would reduce coverage by 4 million in 2019 and 13 million in 2027. Blog post: http://bit.ly/2zvvBRB Analysis: http://bit.ly/2zvy6U2
  • On November 9, CMS released enrollment data for week one of Open Enrollment, finding that over 601,000 people selected plans using Healthcare.gov, including 137,000 new consumers. Press release: http://go.cms.gov/2zvRVuw

Medicare –

  • On November 6, U.S. Government Accountability Office (GAO) published a report finding that while Medicare Part D criteria identifies beneficiaries at the greatest risk of harm from opioid use, it does not capture data on an even larger population of beneficiaries potentially at risk of harm from high doses of opioids. Summary with link to report: http://bit.ly/2m8zE3o
  • On November 8, Senate Judiciary Committee Chair Grassley (R-IA) and Sen. Warren (D-MA) sent a letter to CMS Administrator Verma expressing “interest in the inclusion of device identifier information on Medicare claim forms.” Letter: http://bit.ly/2zvaPBt

Medicaid and CHIP

  • On November 7, CMS announced several new policies and initiatives that encourage states to propose innovative Medicaid reforms, including improved and streamlined 1115 demonstrations, state plan amendments, and 1915 waiver processes and the creation of the first-ever Medicaid and CHIP scorecards. Press release: http://go.cms.gov/2iHssGo Fact sheet: http://go.cms.gov/2zvWqVM Guidance: http://bit.ly/2zvLmYO and http://bit.ly/2hb2B9b
  • Also on November 7, CMS released the federal fiscal year 2016 Drug Utilization Review (DUR) annual state reports as well as a state comparison and summary report. Reports: http://bit.ly/2zvcwyM
  • On November 9, CMS released an informational bulletin providing operational information to support state efforts during the current federal funding shortfall situation for the Children’s Health Insurance Program. Bulletin: http://bit.ly/2Asl88K

Mental Health and Substance Abuse –

  • On November 9, Sens. Shaheen (D-NH), Cornyn (R-TX), and 30 bipartisan Senators sent a letter to Attorney General Sessions asking him to provide Congress with information detailing how the Department of Justice is supporting and prioritizing forensic science service providers across the nation as part of a broader approach to combat the opioid epidemic. Press release: http://bit.ly/2ArhY4Z Letter: http://bit.ly/2Asv0zn

FDA and Prescription Drugs –

  • On November 6, FDA announced the approval of a blood cell count test that can be run in more health care settings, including physicians’ offices, clinics, or other types of health care facilities, by a wider range of personnel like support staff. Press release: http://bit.ly/2iIalQm
  • Also on November 6, FDA Commissioner Gottlieb posted a statement highlighting FDA’s streamlined development and review pathway for consumer tests that evaluate genetic health risks, including steps to implement a novel regulatory approach for the regulation of genetic health risk tests and a final order exempting genetic carrier screening tests from premarket review. Statement: http://bit.ly/2iHMoZx
  • Also on November 6, Food and Drug Administration (FDA) announced the approval of the first treatment to treat certain adult patients with Erdheim-Chester Disease, a rare cancer of the blood. Press release: http://bit.ly/2iI9XkS
  • On November 7, FDA released guidance intended to promote the safe use of nonprescription aspirin drug products by encouraging drug manufacturers, packagers, and labelers marketing aspirin drug products with cardiovascular-related imagery to include a statement that reminds consumers to talk to their health care provider before using aspirin for their heart. Notice of Availability: http://bit.ly/2iHs9ez Guidance: http://bit.ly/2iGvx9D
  • Also on November 7, FDA released guidance for industry to assist sponsors in all phases of development of direct-acting antiviral drugs for the treatment of chronic hepatitis C. Notice of availability: http://bit.ly/2iGkIEo Guidance: http://bit.ly/2iEQySd
  • On November 9, FDA released guidance describing how the review of original abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements will be prioritized for review within FDA. Guidance: http://bit.ly/2Arl60P
  • Also on November 9, House Diabetes Caucus Co-Chairs DeGette (D-CO) and Reed (R-NY) issued a request for information (RFI) for information on whether value-based contracting could be applied to insulin. Comments are due by December 15. Press release: http://bit.ly/2At2jCb RFI: http://bit.ly/2AuEpq5

Health IT –

  • On November 6, National Institutes of Health (NIH) announced 12 awards totaling $9 million in FY 2017 to launch its Data Commons Pilot Phase, which will be implemented over 4 years to explore the feasibility and best practices for making digital objects available through collaborative platforms. Press release: http://bit.ly/2iFmYMj
  • On November 8, HHS Office of the National Coordinator for Health IT (ONC) announced the winners of the Patient Matching Algorithm Challenge. Press release: http://bit.ly/2iHEq2G

 Veterans Health –

  • On November 6, Department of Veterans Affairs (VA) announced changes to its Inbox Notifications system to help give primary care physicians more time to devote to patient care. Press release: http://bit.ly/2zvfyTG
  • On November 8, VA OIG released a report finding that the VA did not fully comply with the Digital Accountability and Transparency Act of 2014 (DATA Act) due to weaknesses in VA’s existing financial management systems and internal controls. Summary with link to report: http://bit.ly/2zwTfx7

 Misc. –

  • Also on November 6, GAO published a report finding that enrollment in the Federal Employees Health Benefits Program (FEHBP) remains concentrated despite more plan offerings. Summary with link to report: http://bit.ly/2iGmfKU
  • On November 7, U.S. Preventive Services Task Force posted a draft recommendation statement and draft evidence review on screening for osteoporosis to prevent fractures, recommending screening of osteoporosis in women age 65 years and older and in women younger than age 65 years who have been through menopause and are at increased risk for osteoporosis. Report: http://bit.ly/2m559LG
  • Also on November 7, Sen. Warren (D-MA) led a group of 11 Senators in a letter to CDC Director Fitzgerald, requesting information on the spread of water- and vector-borne diseases in Puerto Rico and the U.S. Virgin Islands. Press release: http://bit.ly/2ArLWpz Letter: http://bit.ly/2Argwjm
  • On November 9, CDC published a report finding that 1 in 5 US adults used some form of tobacco product in 2015. Press release: http://bit.ly/2iHU660
  • Also on November 9, House Energy & Commerce Committee Chair Walden (R-OR), Ranking Member Pallone (D-NJ), and Oversight & Investigations Subcommittee Ranking Member DeGette (D-CO) sent two letters to the GAO requesting a study examining the epidemiology of antibiotic resistant bacteria, commonly known as “superbugs,” and another on how federal agencies use predictive models to inform their decision-making. Press releases: http://bit.ly/2AuD1DT and http://bit.ly/2AsPDeR Letters: http://bit.ly/2AuDBS5 and http://bit.ly/2AtySzY
  • Also on November 9, HHS released a chart book highlighting trends in employer-sponsored coverage, premiums, and benefits from 2003 to 2016. Chart book: http://bit.ly/2ArgRm8
  • Also on November 9, HHS released a new online inventory to help researchers, state health officials, health system administrators, and other identify measurement tools that can be used with all-payer claims database data. Inventory: http://bit.ly/2Arfl3q