What’s Ahead: This Week

Hearings/Markups –

  • Tuesday, July 18
    • House Energy & Commerce Committee, Subcommittee on Oversight & Investigations, “Examining HRSA’s Oversight of the 340B Drug Pricing Program.”
  • Wednesday, July 19
    • House Committee on Appropriations, “Fully Committee Markup: FY 2018 State and Foreign Operations Appropriations Bill, and FY18 Labor, Health & Human Services, and Education Appropriations Bill.”
    • House Ways & Means Committee, Subcommittee on Oversight, “Efforts to Combat Waste, Fraud, and Abuse in the Medicare Program.”
    • House Committee on Veterans’ Affairs, “Markup of Pending Legislation.”
  • Thursday, July 20
    • House Energy & Commerce Committee, Subcommittee on Health, “Examining Bipartisan Legislation to Improve the Medicare Program.”

Notable Policy Events –

  • Monday, July 17
    • Center for American Progress (CAP), “The Healthcare Fight: Ensuring Access to Prescription Drugs.” Additional information: http://bit.ly/2vsgNzQ
  • Tuesday, July 18
    • Alliance for Health Policy, “Coordinated Care and Beyond: The Future of Chronic Care.” Additional information: http://conta.cc/2v0XIp5
    • Altarum Center for Sustainable Health Spending, “Beyond the ACA: Health Policy and Sustainable Health Spending.” Additional information: http://bit.ly/2uNSgGa
    • The Hill, “The State of Mental Health Care: Challenges and Solutions.” Additional information: http://bit.ly/2urbaW8
  • Wednesday, July 19
    • Network for Excellence in Health Innovation, “Innovations in Payment: Care Delivery Models with CMS & Leading Healthcare Innovators.” Additional information: http://bit.ly/2uNkosK
    • Manhattan Institute, “The Drug-Pricing Challenge: Expanding Access, Accelerating Innovation, Growing the Economy.” Additional information: http://bit.ly/2tZU3rC
    • National Press Foundation, “Preventive Health – What’s Next?” Additional information: http://bit.ly/2tZC5VU
    • Senate Competitiveness Caucus, “Faster and Safer Drug Production through Continuous Manufacturing.” Additional information: http://bit.ly/2tZtin5
  • Thursday, July 20
    • The Hill, “The Prescription Drug Delivery System: Tackling Costs, Ensuring Access.” Additional information: http://bit.ly/2urt4bA

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

 Appropriations –

  • On July 12, House Committee on Appropriations released the Fiscal Year 2018 Labor, Health & Human Services, and Education Funding bill, which proposes to provide HHS with $77.6 billion in discretionary funding, a decrease of $542 million below the FY 2017 enacted level. CMS would receive $3.5 billion, which is $219 million below the FY 2017 enacted level. Press release: http://bit.ly/2v1vTwV Bill text: http://bit.ly/2v1ksoX
  • Also on July 12, Senate Committee on Appropriations approved the FY 2018 Military Construction, Veterans Affairs and Related Agencies Appropriations Bill (S. 1557), which would include $88.9 billion in FY2018 funding, $6.1 billion above FY 2017 funding. The House Appropriations Committee previously approved their version of the funding bill on June 15. Press release: http://bit.ly/2thgQSy Bill text: http://bit.ly/2thgxac

 Legislative Activity –

  • On July 10, Reps. Poliquin (R-ME), Bergman (R-MI), and Kuster (D-NH) introduced the VA Acquisition Workforce Improvement and Streamlining Act (H.R. 3169), which would improve the hiring, training, and efficiency of acquisition personnel and organizations of the Department of Veterans Affairs. Press release: http://bit.ly/2tR0H4L
  • Also on July 10, Rep. Brady (R-TX) introduced H.R. 3172, which would extend the Medicare Patient IVIG Access Demonstration Project. Press release: http://bit.ly/2tROWez
  • On July 11, Rep. Issa (R-CA) introduced the Keeping Our Commitment to Disabled Veterans Act (H.R. 3177), which would extend the requirement to provide nursing home care to certain veterans with service-connected disabilities. Press release: http://bit.ly/2tRywCS
  • Also on July 11, Reps. Black (R-TN), Thompson (D-CA), Collins (R-NY), and Welch (D-VT) introduced the Medicare Choices Empowerment and Protection Act (H.R. 3181), which would encourage Medicare beneficiaries to voluntarily adopt advance directives guiding the medical care they receive. Sens. Coons (D-DE), Cassidy (R-LA), Barrasso (R-WY), and Bennet (D-CO) introduced a companion bill in the Senate (S. 1530). Press release: http://bit.ly/2vlqwrP
  • On July 12, the House passed by a voice vote the FDA Reauthorization Act of 2017 (H.R. 2430), which would revise and extend for five years the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar products. The bill now moves to the Senate for consideration. Press release: http://bit.ly/2uSX8d0 Senate HELP Committee Chair Alexander (R-TN) Press release: http://bit.ly/2uSEXUG
  • Also on July 12, Sens. Grassley (R-IA), Stabenow (D-MI), Cotton (R-AR), Udall (D-NM), Heinrich (D-NM), and Brown (D-OH) introduced the Helping Ensure Life- and Limb-Saving Access to Podiatric Physicians (HELLPP) Act (S. 1533), which would cover physician services delivered by podiatric physicians to ensure access by Medicaid beneficiaries to appropriate quality foot and ankle care and to modify the requirements for diabetic shoes to be included under Medicare. Press release: http://bit.ly/2sZ2XnX
  • Also on July 12, Rep. Kennedy (D-MA) introduced the CHIP Mental Health Parity Act (H.R. 3192), which would ensure access to mental health services for children under the Children’s Health Insurance Program. Press release: http://bit.ly/2urTIB6
  • On July 13, Sens. Strange (R-AL), Cotton (R-AR), Inhofe (R-OK), and Rubio (R-FL) introduced the VA Quality Employment Act of 2017 (S. 1550), which would improve the authority of the Secretary of Veterans Affairs to hire and retain physicians and other employees of the Department of Veterans Affairs. Press release: http://bit.ly/2tb3lnz
  • Also on July 13, Sen. Johnson (R-WI) introduced the Stopping Overdoses of Fentanyl Analogues (SOFA) Act (S. 1553), which would list fentanyl analogues as schedule I controlled substances. Press release: http://bit.ly/2tUqAzc
  • Also on July 13, Sen. Tester (D-MT) and 7 cosponsors introduced the Improving Veterans Access to Community Care Act (S. 1526), which would appropriate amounts to the Department of Veterans Affairs to improve the provision of health care for veterans. Press release: http://bit.ly/2u000F0
  • Also on July 13, Sens. Donnelly (D-IN) and Rounds (R-SD) introduced the VA Prescription Data Accountability Act (S. 1567), which would clarify the authority of the Secretary of Veterans Affairs to disclose certain patient information to state controlled substance monitoring programs. Press release: http://bit.ly/2tZYXoB
  • Also on July 13, Sens. Markey (D-MA), Blumenthal (D-CT), Warren (D-MA), Feinstein (D-CA), and Manchin (D-WV) introduced the Safe Prescribing of Controlled Substances Act (S. 1554), which would require certain practitioners authorized to prescribe controlled substances to complete continuing education. Press release: http://bit.ly/2tgOx6G

 ACA Repeal and Replacement Activity –

  • On July 10, Senate Minority Leader Schumer (D-NY), Minority Whip Durbin (D-IL), Senate HELP Committee Ranking Member Murray (D-WA) and Sen. Stabenow (D-MI) sent a letter to Senate Majority Leader McConnell (R-KY) urging him to “focus on immediately advancing policies to provide stability and certainty to the health insurance markets” and highlighting several bills introduced by Democrats to address these issues. Letter: http://bit.ly/2uT8hdB
  • On July 11, Sen. Heitkamp (D-ND) introduced the Addressing Affordability for More Americans Act (S. 1529) which would expand eligibility for the refundable credit for coverage under a qualified health plan. Press release: http://bit.ly/2tTTzD7
  • On July 12, White House Council of Economic Advisors (CEA) released its analysis of the Congressional Budget Office’s (CBO) estimate of the Better Care Reconciliation Act (BCRA), arguing that BCRA results in at least $265 billion more federal Medicaid spending between 2018 and 2016. Press release: http://bit.ly/2uSUPXf Analysis: http://bit.ly/2uSMraf
  • Also on July 12, Sen. Warner (D-VA) and 9 Democratic cosponsors introduced the States Achieve Medicaid Expansion (SAME) Act  (S. 1545), which would provide the same level of federal matching assistance for every state that chooses to expand Medicaid coverage to newly eligible individuals, regardless of when such expansion takes place. Sen. Warner also introduced, along with Sens. Manchin (D-WV), Heitkamp (D-ND) and King (I-ME), the Commonsense Competition and Access to Health Insurance Act (S. 1546), which would provide greater flexibility in offering health insurance across state lines. Press release: http://bit.ly/2unAkF8 Summaries: http://bit.ly/2uo6xMx and http://bit.ly/2unCoNv
  • Also on July 12, Sen. Brown (D-OH) released a report outlining the consequences of repealing the ACA for Ohio’s rural communities. Press release with link to report: http://bit.ly/2ummhjc
  • Also on July 12, Sen. Graham (R-SC) released a proposed amendment to the BCRA, which would block grant current ACA subsidy funding – an estimated $116 billion in 2016 – to the states to use for health care spending. Press release: http://bit.ly/2uWSmeG
  • Also on July 12, Reps. Schrader (D-OR), Bera (D-CA), Kuster (D-NH) and seven other Democratic representatives released a five-part plan to improve upon the ACA and stabilize the individual marketplace. The plan would protect plans for people with pre-existing conditions, keep costs down for lower income families, promote enrollment and ensure people pay their fair share, create more affordable insurance options, and would make other technical changes and improvements to the law. Press release: http://bit.ly/2uTbt9o Plan: http://bit.ly/2uSXUGV
  • On July 13, Senate Budget Committee released an updated version of the Better Care Reconciliation Act of 2017, which provides more substantial funding for market stabilization and to combat the opioid epidemic than the previous version. Press release: http://bit.ly/2tyHHpL CMS Press release: http://go.cms.gov/2tZpzWM Section-by-section: http://bit.ly/2unIKMFSummary of Cruz Amendment: http://bit.ly/2unRP8a Bill text: http://bit.ly/2unA7lr
  • On July 14, Rep. Loebsack (D-IA) introduced the Holding Congress Accountable on Healthcare Act (H.R. 3253), which would provide for the health coverage of Members of Congress to be affected if the rate of individuals without health insurance decreases. Press release: http://bit.ly/2thxrpb

ACA Implementation –

  • On July 10, CMS announced that 141 individual market Qualified Health Plan (QHP) issuers submitted initial applications to offer coverage using the federally-facilitated exchange in 2018, a reduction from the 227 issuers that submitted an initial application in 2016. On July 12, CMS released an updated map of projected issuer participation in the exchanges in 2018. Press release: http://go.cms.gov/2uTfVoG HHS Secretary Price statement: http://bit.ly/2uSvRaH Map: http://go.cms.gov/2uSPqzx
  • On July 11, CMS announced the approval of Alaska’s section 1332 Innovation Waiver, which would establish the Alaska Reinsurance Program for 2018 and future years in an effort to stabilize the individual healthcare market in the state. Alaska is the second state to receive approval for a 1332 waiver. CMS Press release: http://go.cms.gov/2uSRLuc HHS Secretary Price Press release: http://bit.ly/2uTcuhI Senate HELP Committee Chair Alexander (R-TN) Press release: http://bit.ly/2uSKvys Waiver summary: http://go.cms.gov/2uSSTOE
  • On July 12, CMS released filing instructions for the 2016 Medical Loss Ratio (MLR) reporting year. Instructions: http://go.cms.gov/2v1Qn8M
  • On July 13, CMS released guidance on annual eligibility redetermination and re-enrollment for exchange coverage in 2018. Guidance: http://go.cms.gov/2unRl2d
  • Also on July 13, Government Accountability Office (GAO) published a report on improper payments, finding that improvement are needed in CMS and IRS controls over the health insurance premium tax credit. Report: http://bit.ly/2tRLQY9

Medicare –

  • On July 13, CMS released a proposed rule updating payment and policies for the Calendar Year (CY) 2018 Physician Fee Schedule. In addition to updated payment policies, payment rates, and quality provisions, the rule also proposed policies for the expansion of the Diabetes Prevention Program (DPP) within Medicare. Comments are due by September 11. PFS Press release: http://go.cms.gov/2unRjWX DOO Press release: http://go.cms.gov/2v11cI1 PFS Fact sheet: http://go.cms.gov/2v1py4m DPP Fact sheet: http://go.cms.gov/2v1ieWD Proposed rule: http://bit.ly/2v1qm9A
  • Also on July 13, CMS released a proposed rule updating payment rates and policies for CY 2018 for the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System. CMS estimates that updates in the proposed rule would increase OPPS payments by 1.75 percent in 2018. Comments are due by September 11. Press release: http://go.cms.gov/2tSguQW HHS Secretary Price Press release: http://bit.ly/2vmvm81 Fact sheet: http://go.cms.gov/2v1qFBg Proposed rule: http://bit.ly/2v1us1w
  • Also on July 13, HHS published a report from the Medicare Trustees finding that the trust fund financing Medicare’s hospital insurance coverage will be depleted in 2029, one year later than was projected in last year’s report. The Chief Actuary of CMS also determined that the Independent Payment Advisory Board (IPAB) is not triggered, but is now projected to be triggered in 2021. Press release: http://bit.ly/2toaBaP Report: http://go.cms.gov/28PqliB IPAB Determination Letter: http://go.cms.gov/2tcbSX3

 Health IT –

  • On July 12, Senate Judiciary Chair Grassley (R-IA) sent a letter to CMS Administrator Verma urging her to recover as much as possible of more than $729.4 million in reported inappropriate electronic health records incentive program payments. Press release: http://bit.ly/2th2h1t Letter: http://bit.ly/2thqCUL

Veterans Healthcare –

  • On July 10, GAO released a report finding that VA is limited in its ability to understand, process, and communicate decisions on claims related to Gulf War Illness. GAO released a second report on July 13 outlining additional actions needed. Summaries with link to reports: http://bit.ly/2v1rxpC and http://bit.ly/2v1Anng
  • On July 12, GAO released a report finding that two of the planning processes that VA uses to align its facilities have limitations that undermine VA’s efforts to achieve its goals. Summary with link to report: http://bit.ly/2v16UJX
  • On July 13, the GAO published a report finding that further improvements that are needed in data and monitoring of clinical productivity and efficiency at the VA. Summary with link to report: http://bit.ly/2v1mfKy

 Mental Health and Substance Abuse –

  • On July 10, Food and Drug Administration (FDA) published a paper suggesting that claims data alone are not enough to determine the efficacy of abuse-deterrent opioids and that the agency can use prescription data to spot so-called “doctor shopping.” Full paper: http://bit.ly/2usM4pT
  • On July 11, Sens. Durbin (D-IL) led a group of 16 Senators in a letter to Drug Enforcement Administration Acting Administrator Rosenberg, urging the agency to better prevent painkillers from flooding the market by setting lower opioid production quotas for 2018. Press release: http://bit.ly/2tgLwU9 Letter: http://bit.ly/2thlrnE
  • On July 12, Substance Abuse and Mental Health Services Administration (SAMHSA) published two new data reports on the state of quality assurance practices related to the workforce in substance abuse and mental health treatment facilities. Press release: http://bit.ly/2tMo5k9
  • On July 13, SAMHSA published a report finding that 4.31 percent of people aged 12 or older in the U.S. used prescription pain relievers non-medically in the past year. Press release: http://bit.ly/2tbItfV
  • Also on July 13, National Academy of Medicine released a report on pain management and the opioid epidemic, which argues for a sustained, coordinated effort to stem the escalating prevalence of opioid-related harms. Summary with link to report: http://bit.ly/2sYmwfR FDA statement: http://bit.ly/2tkaOvr
  • Also on July 13, HHS Office of the Inspector General (HHS-OIG) published a report highlighting concerns about extreme use and questionable prescribing in Medicare Part D, finding that 1 in 3 beneficiaries received a prescription opioid in 2016 and about 400 prescribers had questionable opioid prescribing patterns for beneficiaries at serious risk. Summary with link to report: http://bit.ly/2ungLNm
  • Also on July 13, House Energy & Commerce Committee Chair Walden (R-OR), Ranking Member Pallone (D-NJ), Subcommittee on Oversight & Investigation Chair Murphy (R-PA) and Ranking Member DeGette (D-CO), and Subcommittee on Health Chair Burgess (R-TX) and Ranking Member Green (D-TX) sent a letter to HHS Secretary Price regarding reports of “patient brokers” who are serving as an intermediary and profiting from recruiting patients seeking treatment for opioid addiction, and requesting information about HHS’ efforts to ensure oversight and accountability of treatment centers. Press release: http://bit.ly/2urNlOb Letter: http://bit.ly/2urF904
  • On July 14, the Department of Health and Human Services (HHS) announced $80.8 million in grants over a period of three to five years for treatment drug court programs for people who are involved in the criminal justice system with substance use disorders and co-occurring mental and substance use disorders. Press release: http://bit.ly/2vlgEOI
  • Also on July 14, FDA released a timeline of selected FDA activities and significant events in addressing opioid misuse & abuse. Timeline: http://bit.ly/2uAqO1G

 Drug Prices –

  • On July 11, Sens. Warner (D-VA), Cassidy (R-LA), Bennet (D-CO), and Young (R-IN) wrote a letter urging the GAO to look into private sector innovations related to outcome-based arrangements with drug manufacturers to determine how to help lower prescription drug costs for patients, providers, and payers. Press release: http://bit.ly/2tUIzpj Letter: http://bit.ly/2v1t6E4
  • Also on July 11, GAO published a report highlighting efforts that the FDA has taken to improve the Expanded Access Program and recommending that FDA should further clarify how adverse events data is used. Summary with link to report: http://bit.ly/2v1j9GF

Misc. –

  • On July 11, U.S. Preventive Services Task Force (USPSTF) issued a final recommendation statement and evidence summary on behavioral counseling to promote a healthy lifestyle in adults without risk factors for cardiovascular disease. Press release: http://bit.ly/2uj5wVQ
  • On July 14, GAO published a report on the eligibility and benefits for federal low-income programs, finding complex and varied rules among states. Summary with link to report: http://bit.ly/2unola0
  • Also on July 14, HHS released a report finding that from 2015 to 2016, there was no statistically significant change in either the overall percentage of private-sector employees covered by employer-sponsored coverage or in the number of enrollees. Report: http://bit.ly/2uAcc2h