What’s Ahead: This Week

Hearings –

  • Thursday, June 29
    • House Committee on Veterans’ Affairs, Subcommittee on Oversight and Investigations, “Oversight and Investigations Legislative Hearing.”
    • House Committee on Veterans’ Affairs, Subcommittee on Economic Opportunity, “Economic Opportunity Legislative Hearing.”

Notable Policy Events –

  • Monday, June 26
  • Tuesday, June 27
  • Wednesday, June 28
    • Urban Institute, “Stabilizing the Individual Market: What is the Role for Risk Adjustment and Risk Mitigation?” Additional information: http://urbn.is/2sQI7Yn
    • Bipartisan Policy Center (BPC), “Cybersecurity and Medical Devices: Risk Assessment and Response.” Additional information: http://bit.ly/2tuuApi
    • Coalition to Transform Advanced Care (C-TAC), “Transforming Care: A New Campaign to Accelerate the Movement.” Additional information: http://bit.ly/2sQzNrz
    • Personal Connected Health Alliance and the HIMSS Foundation Institute for e-Health, “Making it Personal: The Connected Health Technology Revolution.” Additional information: http://bit.ly/2tuesEz
    • Cato Institute, “A ‘Modern Plague’? How the Federal Government Should Address the Opioid Crisis.” Additional information: http://bit.ly/2sQGl9I
  • Wednesday, June 28 – Thursday, June 29
  • Thursday, June 29
    • BPC, “Future of Health Care: Balancing Coverage and Cost in Medicaid.” Additional information: http://bit.ly/2sQUVhq
    • American Enterprise Institute (AEI), “The Role of Government in Medical Innovation.” Additional information: http://bit.ly/2sQWhsw


Weekly Wrap Up: Notable Health Care Developments From Last Week

 Legislative Activity –

  • On June 19, Sens. Wicker (R-MS) and Schatz (D-HI) introduced the Reaching Underserved Rural Areas to Lead on Telehealth (RURAL) Act (S. 1377), which would remove the limitation on certain amounts for which large non-rural hospitals may be reimbursed under the Healthcare Connect Fund or the Federal Communications Commission. Press release: http://bit.ly/2rZKw5Z
  • On June 20, the House passed by a voice vote the Partnership Grants to Strengthen Families Affected by Parental Substance Abuse Act (H.R. 2834), which would improve the well-being of, and improve permanency outcomes for, children and families affected by heroin, opioids, and other substance abuse. Press release: http://bit.ly/2sZiBCy
  • Also on June 20, the House passed by a voice vote the Supporting Families in Substance Abuse Treatment Act (H.R. 2857), which would support foster care maintenance payments for children with parents in a licensed residential family-based treatment facility for substance abuse. Press release: http://bit.ly/2sZiBCy
  • Also on June 20, Reps. Fitzpatrick (R-PA), Murphy (D-FL), MacArthur (R-NJ), Kuster (D-NH), and Norcross (D-NJ) introduced the Road to Recovery Act (H.R. 2938), which would remove barriers to access to residential substance use disorders treatment services under Medicaid and the Children’s Health Insurance Program (CHIP). Press release: http://bit.ly/2tCDWiY
  • Also on June 20, Rep. Gohmert (R-TX) introduced the Parental Notification and Intervention Act (H.R. 2956), which would provide for parental notification and intervention in the case of an emancipated minor seeking an abortion. Press release: http://bit.ly/2sRPqkM
  • On June 21, Reps. Waters (D-CA) and Smith (R-NJ) introduced the Alzheimer’s Caregiver Support Act (H.R. 2972), which would authorize grants for training and support services for Alzheimer’s patients and their families. Press release: http://bit.ly/2tX5G12
  • Also on June 21, Reps. Pocan (D-WI) and Kaptur (D-OH) introduced the Stop Price Gouging Act (H.R. 2974), which would establish an excise tax on certain prescription drugs that have been subject to a price spike. Press release: http://bit.ly/2sZjwTw
  • On June 22, House Energy & Commerce Committee, Subcommittee on Health Chair Burgess (R-TX) and Rep. DeGette (D-CO) introduced the Preventive Health Savings Act of 2017 (H.R. 2952), which would amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings. Press release: http://bit.ly/2t4ttA0
  • On June 22, Rep. McKinley (R-WV) and nine bipartisan cosponsors introduced the Patients’ Access to Treatment Act (H.R. 2999), which would limit co-payment, coinsurance, or other cost-sharing requirements applicable to prescription drugs in a specialty drug tier to the dollar amount of such requirements applicable to prescription drugs in a non-preferred brand drug tier. Press release: http://bit.ly/2rKxtBo
  • On June 23, President Trump signed into law the Department of Veterans Affairs Accountability and Whistleblower Protection Act of 2017 (S. 1094), which would make a number of changes to the Department of Veterans Affairs authorities related to personnel, accountability, and whistleblower protections. Press releases: http://bit.ly/2t3Q0g9 and http://bit.ly/2sQML8R and http://bit.ly/2sQSpbb
  • Also on June 23, Reps. Katko (R-NY) and Thompson (D-CA) introduced the Mental Health Improvement Act (H.R. 3032), which would provide for the coverage of marriage and family therapist services and mental health counselor services under Part B of the Medicare program. Press release: http://bit.ly/2tdiPXE

 ACA Repeal and Replacement Activity –

  • On June 20, Sen. Manchin (D-WV) released a report detailing how the American Health Care Act (AHCA) as passed by the House would worsen the opioid crisis in West Virginia. Press release: http://bit.ly/2tuidtt Report: http://bit.ly/2tuNTis
  • Also on June 20, National Governors Association released a set of bipartisan ideas from 13 states to improve health care through reforms to private health insurance, Medicaid and public health. Press release: http://bit.ly/2tuONvm Report: http://bit.ly/2tusBBs
  • On June 21, the White House unveiled a new webpage arguing for a repeal of the ACA, describing how the ACA has resulted in higher premiums, more costly deductibles, and fewer insurance options for Americans. Website: http://bit.ly/2tyxOYU
  • Also on June 21, Sens. Casey (D-PA and Heinrich (D-NM) released a report outlining the impact that AHCA would have on rural hospitals. Press release: http://bit.ly/2sQUBPX Report: http://bit.ly/2sR1yR0
  • Also on June 21, Sen. Paul (R-KY) introduced a resolution (S. Res. 197) which would eliminate the Senate’s ability to consider any bill or other matter until one session day has passed since introduction for every 20 pages included. Press release: http://bit.ly/2tySYX2 Resolution: http://bit.ly/2tyxVUm
  • Also on June 21, Rep. Maloney (D-NY) introduced three bills that would restrict coverage for certain Members of Congress: the No Carve Out for Congress Act (H.R. 2985) would restrict members of Congress who represent a state with an essential health benefits (EHB) waiver to the lowest actuarial value health insurance coverage that is available under that waiver; the Good for the Gander Act (H.R. 2986), would restrict members of Congress who represent a state with an age band waivers to the highest age band premium for coverage available under the waiver; and the High Risk Pool, No Reward Act (H.R. 2984) would restrict members of Congress who represent a state with a waiver to the same coverage available under such waiver. Press release: http://bit.ly/2tyRhZM
  • On June 22, Senate Republicans released a discussion draft of the Better Care Reconciliation Act (BCRA) of 2017, their version of the House-passed AHCA (H.R. 1628). The bill would repeal the ACA’s individual and small business mandate, revise the premium tax credits, and overhaul the Medicaid program. Press releases – Senate Budget Committee Chair Enzi (R-WY): http://bit.ly/2tyT01c Senate Finance Chair Hatch (R-UT): http://bit.ly/2tyFx9x Senate HELP Committee Chair Alexander: http://bit.ly/2tySy30 HHS Secretary Price: http://bit.ly/2tz9aYq CMS Administrator Verma: http://go.cms.gov/2tyTxzY Overview: http://bit.ly/2tyHHpL Section-by-section: http://bit.ly/2t2Cycm Bill text: http://bit.ly/2tzacUm
  • Also on June 22, Congressional Budget Office (CBO) released a statement announcing their intention to publish a score of the BCRA “early next week.” Announcement: http://bit.ly/2tz2o50
  • On June 23, Sen. Murphy (D-CT) sent a letter to CBO Director Hall requesting that the CBO provide an analysis of the BRCA Discussion draft as written as well as an estimate of the impact of the legislation beyond the first 10-year budget window. Press release with link to letter: http://bit.ly/2tMwfXG

 ACA Implementation –

  • On June 23, CMS released a series of example notices that will be sent to consumers applying for coverage through a special enrollment period (SEP). CMS is now requiring 100% of applicants for SEPs to provide documentation verifying their eligibility for a SEP. Press release from House Committee on Energy & Commerce: http://bit.ly/2t4lQJz Link to notices: http://bit.ly/2t4JJ3L

Medicare –

  • On June 20, CMS issued a proposed rule that would make changes in the second year of the Quality Payment Program, as established by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The rule would make it easier for small, rural, and independent practices to meet the program’s requirements, and makes revisions to both the Merit-based Incentive Payment System and the requirements for Advanced Alternative Payment Models. Comments are due by August 21. Press release: http://go.cms.gov/2snl3lp Fact Sheet: http://go.cms.gov/2sniRL0 Proposed Rule: http://bit.ly/2snowAq

 New Payment and Delivery System Reform Models –

  • On June 21, CMS published the final evaluation report for the three-year Federally Qualified Health Center Advanced Primary Care Practice Demonstration, which concluded on October 31, 2014. Report: http://bit.ly/2rKTUWR

Health IT –

  • On June 21, Food and Drug Administration (FDA) published a proposed rule providing guidance to sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on the use of electronic records and electronic signatures under FDA regulations in clinical investigations of medical products. Comments are due by August 21. Proposed Rule: http://bit.ly/2rZzUUS

 Veterans Healthcare –

  • On June 20, Department of Veterans Affairs (VA) announced a plan to dispose of all vacant VA buildings in 24 months. Press release: http://bit.ly/2t3Jwxe
  • On June 21, U.S. Government Accountability Office (GAO) published a report on the Veterans’ Health Administration’s (VHA) IT management processes, finding that VHA’s IT strategic plans do not include performance measures and targets for their defined objectives. Summary with link to report: http://bit.ly/2s3Qy0L
  • On June 23, GAO published a report finding that improvements are needed in the VA’s data and monitoring of clinical productivity and efficiency of its health care providers and medical centers. Summary with link to report: http://bit.ly/2tCbfTb
  • On June 23,the VA Office of Inspector General (VA-OIG) published a review of information posted on the Veterans Health Administration’s (VHA) “Our Doctors” website, finding that VHA had not clearly defined the processes involved in uploads of information, had not required adequate validation prior to posting information, and had not defined a frequency of updates that would identify normal changes occurring in providers’ credentials over time. Report: http://bit.ly/2t3vege

 Mental Health and Substance Abuse –

  • On June 20, Substance Abuse and Mental Health Services Administration (SAMHSA) announced the award of $4.9 million in grants to 17 colleges and universities for suicide prevention and mental health promotion activities. Press release: http://bit.ly/2sZEGkd
  • Also on June 20, HHS published a report finding that between 2005 and 2014 opioid-related inpatient stays and emergency department visits increased for both sexes and all age groups. Report: http://bit.ly/2tL4Ggi
  • On June 21, SAMHSA announced funding of up to $44.6 million for the Addiction Technology Transfer Centers Cooperative Agreements, which are intended to expand the behavioral healthcare workforce. Press release: http://bit.ly/2t3uxUP
  • On June 22, SAMHSA published a report finding that underage binge drinking rates have declined over the past 6 years but it is a continuing public health issue with 14 percent of teens and young adults aged 12-20 engaging in binge drinking in the past month. Press release: http://bit.ly/2t3sGyQ Report: http://bit.ly/2s48wjs

 Drug Prices –

  • On June 19, Senate Judiciary Chair Grassley (R-IA) sent a letter to the Food and Drug Administrator Gottlieb urging him to examine legislative proposals and to collaborate with other government agencies to increase consumer access to affordable prescription medicines. Press release: http://bit.ly/2t2POh4 Letter: http://bit.ly/2t2CsBE
  • On June 21, Reps. Welch (D-VT) and Cummings (D-MD) sent a letter to President Trump in reaction to press reports that he will soon sign an executive order that, they argue, is favorable to the pharmaceutical industry and will provide no relief on high drug price increases. Press release: http://bit.ly/2t2D2iy Letter: http://bit.ly/2t2rzzF
  • Also on June 21, FDA Commissioner Gottlieb published a blog post announcing FDA’s plans to work on a Drug Competition Action Plan and to hold a public meeting on July 18, 2017 to solicit input on places where FDA’s rules – including the standards and procedures related to generic drug approvals – are being used in ways that may create obstacles to generic access. Blog post: http://bit.ly/2sqamP7
  • On June 22, Diabetes Caucus Co-Chairs DeGette (D-CO) and Reed (R-NY) sent letters to the President & Chief Executive Officer of Pharmaceutical Research and Manufacturers of America (PhRMA) and the President & Chief Executive Officer of America’s Health Insurance Plans (AHIP) inviting them to meet for a discussion about insulin prices and policy options to provide relief for patients and their families. Press release: http://bit.ly/2t2FzcQ Letters: http://bit.ly/2t2Ggmw
  • On June 23, Sens. Warren (D-MA), Franken (D-MN) led a letter cosigned by 9 Democratic Senators and 16 Democratic Representatives urging President Trump to push for “real solutions to bring down the skyrocketing price of prescription drugs.” Press release: http://bit.ly/2tMuoCa Letter: http://bit.ly/2tMllRD
  • Also on June 23, Senate Judiciary Committee Chair Grassley (R-IA) and Sen. Klobuchar (D-MN) sent a letter to FDA Commissioner Gottlieb urging him to address abuses in the regulatory process that delay competition and increase prescription drug costs. Press release: http://bit.ly/2tMAgv8 Letter: http://bit.ly/2tMv5eK

 Misc. –

  • On June 20, FDA published draft guidance for industry on pre-submission facility correspondence associated with priority submissions, as part of the performance goals and program enhancements for the Generic Drug User Fee Amendments reauthorization. Comments are due by September 18. Guidance: http://bit.ly/2rKGOZV
  • On June 21, the Federal Communications Commission (FCC) published a final rule amending the Rural Health Care Program’s definition of “health care provider” to include skilled nursing facilities amongst the list of health care providers eligible to receive support. Final Rule: http://bit.ly/2szoBRT
  • On June 23, House Energy & Commerce Committee Chair Walden (R-OR), Subcommittee on Oversight and Investigations Murphy (R-PA), and Subcommittee on Health Chair Burgess (R-TX) sent a letter to CMS Administrator Verma regarding a backlog of recommendations issued by HHS OIG that date back almost 30 years, and requesting that CMS prioritize the top 25 unimplemented recommendations. Press release: http://bit.ly/2t4ltik Letter: http://bit.ly/2t4uEzo