What’s Ahead: This Week

 Hearings/Markups –

  • Tuesday, May 15
    • Senate HELP Committee, “Examining Oversight Reports on the 340B Drug Pricing Program.”
  • Wednesday, May 16
    • House Committee on Veterans Affairs, “Member Day: Testimony and Proposals on the Department of Veterans Affairs.”
  • Thursday, May 17
    • House Energy & Commerce Committee, “Vote on Opioids Legislation.”
    • House Committee on Veterans Affairs, Subcommittees on Health and Oversight & Investigations, “VA Research: Focusing on Funding, Findings, and Partnerships.”
    • House Veterans Affairs Committee, Subcommittee on Economic Opportunity, “A Review of VA’s Vocational Rehabilitation and Employment Program.”
    • House Committee on Oversight and Government Reform, “A Sustainable Solution to the Evolving Opioid Crisis: Revitalizing the Office of National Drug Control Policy.”

 Notable Policy Events –

  • Monday, May 14 –
    • National Institute for Health Care Management (NIHCM), “Reimaging Health Care in America.” Additional information: http://bit.ly/2wu9HQS
    • Washington Post, “America’s Health Future.” Additional information: https://wapo.st/2KhSRGI
  • Wednesday, May 16
    • American Enterprise Institute, “Fixing Health Care: Driving Value through Smart Purchasing and Policy.” Additional information: http://bit.ly/2KiLr69
  • Thursday, May 17
    • Department of Defense, Department of Veterans Affairs, Interagency Program Office, “DoD/VA Industry Interoperability Roundtable.” Additional information: http://bit.ly/2q255KC


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

Appropriations –

  • On May 8, President Trump sent Congress a $15.4 billion rescissions request, which would cut almost $7 billion from the Children’s Health Insurance Program and $800 million from the Center for Medicare and Medicaid Innovation. The request notes that the package includes “unobligated balances from prior-year appropriations and reductions to budget authority for mandatory programs.” Rescissions package: http://bit.ly/2KkHUnM
  • Also on May 8, House Appropriations Committee unanimously advanced the fiscal year 2019 Military Construction-Veterans Affairs appropriations bill (H.R. 5786), which would increase VA discretionary funding by 4.8 percent over fiscal year 2018 levels. The bill now moves to the full House for consideration. Press release: http://bit.ly/2IICYMm

 Legislative Activity –

  • On May 7, the Senate approved by a voice vote the Improving Access to Behavioral Health Information Technology Act (S. 1732), which would promote testing of incentive payments for behavioral health providers for adoption and use of certified electronic health record technology. The bill now moves to the House for consideration. A similar bill, H.R. 3331 was advanced by the House Energy & Commerce Committee yesterday and will now move to the full House for consideration. Press release: http://bit.ly/2Iuy6dY
  • Also on May 7, Reps. Jenkins (R-KS) and Kind (D-WI) introduced the Rural Emergency Medical Center (REMC) Act (H.R. 5678), which would provide for coverage of rural emergency medical center services under the Medicare program. Press release: http://bit.ly/2wrIqOZ
  • Also on May 7, Reps. Norcross (D-NJ) and Brat (R-VA) introduced the Jobs Plus Recovery Act (H.R. 5679), which would require the Secretary of Labor, in consultation with the Secretary of HHS, to establish a pilot program for Jobs Plus Recovery programs. Press release: http://bit.ly/2wtN92u
  • Also on May 7, Reps. Banks (R-IN) and Moulton (D-MA) introduced the Department of Veterans Affairs Oversight Enhancement Act (H.R. 5683), which would Sens. Young (R-IN) and Klobuchar (D-MA) have previously introduced companion legislation in the Senate (S. 2656) Press release: http://bit.ly/2KbsqCA
  • Also on May 7, Reps. Curbelo (D-FL) and Kuster (D-NH) introduced the Hospital Opioid Solutions Toolkit (HOST) Act of 2018 (H.R. 5699), which would direct the Secretary of HHS to develop guidance on pain management and the prevention of opioid use disorder for hospitals receiving payment under Part A of Medicare. Press release: http://bit.ly/2KbulXO
  • Also on May 7, Rep. Bustos (R-IL) introduced the Preventing Neonatal Abstinence Syndrome and Protecting Babies Act (H.R. 5702), which would require the Secretary of HHS to develop a strategy implementing recommendations relating to the Protecting our Infants Act of 2015.  Press release: http://bit.ly/2wvtkbn
  • Also on May 7, Reps. Sanchez (D-CA) and Griffith (R-VA) introduced the Improving Access to Mental Health Services Act (H.R. 5711) which would allow National Health Services Corps members to provide obligated service as behavioral health and mental health professionals at schools, other community-based setting, or patient homes. Sens. Smith (D-MN) and Murkowski (R-AK) previously introduced companion legislation in the Senate (S. 2533). Press release: http://bit.ly/2rBKFu0
  • Also on May 7, Reps. Schrader (D-OR) and Welch (D-VT) introduced the Medicaid Drug Rebate Accountability Act (H.R. 5712), which would compel manufacturers to correct inaccurate classification data reported to the Medicaid rebate program. Press release: http://bit.ly/2wvaGAb
  • On May 8, House Committee on Veterans Affairs approved by a vote of 20-2 the MISSION Act (H.R. 5674), which would establish a permanent community care program for veterans, establish a commission for the purpose of making recommendations regarding the modernization or realignment of facilities of the Veterans Health Administration, improve construction of the Department of Veterans Affairs, and make certain improvements in the laws administered by the Secretary of Veterans Affairs related to the home loan program of the Department of Veterans Affairs. The bill now moves to the full House for consideration. Press releases: http://bit.ly/2IveV3p and http://bit.ly/2wwuXFv VA press release: http://bit.ly/2IB4dZc
  • Also on May 8, House Energy & Commerce Committee voted to advance 25 opioid-related bills. The committee plans to markup and additional set of bills on May 17. The approved bills now move to the full House for consideration. Press release: http://bit.ly/2Ixs4sO
  • On May 9, Sens. Portman (R-OH) and Casey (D-PA) introduced the Medicare Beneficiary Opioid Addiction Treatment Act (S. 2704), which would provide for coverage of methadone under Medicare Part B. Press release: http://bit.ly/2KbRGZH
  • Also on May 9, Reps. Renacci (R-OH), Sewell (D-AL), Guthrie (R-KY) and Peters (D-CA) introduced the Strengthening Partnerships to Prevent Opioid Abuse Act (H.R. 5715), which would provide for certain program integrity transparency measures under Medicare parts C and D. Press release: http://bit.ly/2rzyZIu
  • Also on May 9, Reps. Walorski (R-IN) and Chu (D-CA) introduced the Dr. Todd Graham Pain Management Improvement Act (H.R. 5722), which would direct the Secretary of Health and Human Services to conduct a study and submit to congress a report containing recommendations on how to improve the use of non-opioid treatments for acute and chronic pain management for individuals entitled to benefits under part A or enrolled under part B of the Medicare program. Press release: http://bit.ly/2rBGezm Bill text: http://bit.ly/2rz9WFk
  • Also on May 9, Rep. Barr (R-KY) introduced the Transitional Housing for Recovery in Viable Environments (THRIVE) Act (H.R. 5735), which would establish a demonstration program to set aside section 8 housing vouchers for supportive and transitional housing for individuals recovering from opioid use disorders or other substance use disorders. Press release: http://bit.ly/2rzzUbU
  • Also on May 9, Rep. Barr (R-KY) and 15 cosponsors introduced the Comprehensive Addiction recovery through Effective Employment and Reentry (CAREER) Act (H.R. 5736), which would establish a pilot program to help individuals in recovery from a substance use disorder transition from treatment to independent living and the workforce. Senate majority Leader McConnell (R-KY) previously introduced the CAREER Act in the Senate (S. 2730). Press release: http://bit.ly/2rzzUbU
  • On May 10, Reps Frankel (D-FL) and Keating (R-MA) introduced the Fighting Medicare Fraud Act of 2018 (H.R. 5757), which would expand the permissive exclusion from Federal health programs to include certain individuals with prior interest in sanctioned entities, and entities affiliated with sanctioned entities. Press release: http://bit.ly/2wuzp7C
  • Also on May 10, Reps. Krishnamoorthi (D-IL) and Herrera Beutler (R-WA) and 10 bipartisan cosponsors introduced the Ending Maternal Mortality Act (H.R. 5761), which would direct the Secretary of HHS to submit to Congress on a biennial basis a national plan to reduce the rate of maternal mortality. Press release: http://bit.ly/2IICANU
  • Also on May 10, Sen. McCaskill (D-MO) introduced the Air Ambulance Consumer Protection Act (S. 2812), which would improve consumer protections for customers of air ambulance operators. Press release: http://bit.ly/2wwD98G
  • Also on May 10, Sens. Durbin (D-IL) and Roberts (R-KS) introduced the Supporting and Improving Rural EMS Needs (SIREN) Act (S. 2830), which would reauthorize the rural emergency medical services training and equipment assistance program. Press release: http://bit.ly/2wufeXD
  • On May 11, House Ways & Means Committee Chair Brady (R-TX), Ranking Member Neal (D-MA), and Subcommittee on Health Chair Roskam (R-IL) and Ranking Member Levin (D-MI) released four bills to help combat the opioid crisis: the Preventing Addiction for Susceptible Seniors (PASS) Act (H.R. 5773), the Combatting Opioid Abuse for Care in Hospitals (COACH) Act (H.R. 5774), the Providing Reliable Options for Patients and Educational Resources (PROPER) Act (H.R. 5775), and the Medicare and Opioid Safe Treatment (MOST) Act (H.R. 5776). Press release: http://bit.ly/2IFRDYP
  • Also on May 11, Reps. Gabbard (D-HI), Khanna (D-CA), and Jayapal (D-WA) introduced the Opioid Crisis Accountability Act of 2018 (H.R. 5782), which would hold pharmaceutical companies accountable for illegal marketing and distribution of opioid products and for their role in creating and exacerbating the opioid epidemic in the U.S. Sen. Sanders (I-VT) has previously introduced companion legislation (S. 2691). Press release: http://bit.ly/2IEXk9k

ACA Implementation and Market Stabilization –

  • On May 7, CMS released a set of frequently asked questions (FAQ) related to federally-facilitated exchange user fee adjustment submission requirements. FAQ: https://go.cms.gov/2K8g9z2
  • On May 9, CMS deemed complete and released for public comment Wisconsin’s proposed section 1332 waiver, which would establish a state-based reinsurance program. Comments are due by June 8. Waiver: http://bit.ly/2IvLw9C
  • On May 11, Maine submitted a section 1332 waiver application to CMS, which would establish a reinsurance program in the state. Waiver: http://bit.ly/2IBxkMg

Medicare –

  • On May 9, CMS issued an interim final rule with comment (IFC) to increase the fee schedule rates from June 1, 2018 through December 31, 2018, for certain durable medical equipment items and services and enteral nutrition furnished in rural and non-contiguous areas not subject to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Budding Program. Comments are due by July 9. Press release: https://go.cms.gov/2IxoMps Fact sheet: https://go.cms.gov/2Iu2UeQ IFC: http://bit.ly/2IvsLmA

 Medicaid –

  • On May 7, CMS approved New Hampshire’s request to impose work requirements as a condition of eligibility. Waiver approval: http://bit.ly/2KdAmU7
  • Also on May 7, CMS sent a letter to Kansas informing the state that it will not allow lifetime limits on Medicaid eligibility, as the state had proposed as part of its pending 1115 waiver. Letter: http://bit.ly/2IovFtl
  • On May 10, Joint Economic Committee democratic staff released a report highlighting the benefits of the Medicaid program. Report: http://bit.ly/2rBSQ9K
  • Also on May 10, U.S. Government Accountability Office (GAO) announced two new members of the Medicaid and CHIP Payment and Access Commission (MACPAC), Melanie Bella and Katherine Weno. Current member Stacey Lampkin was named Vice Chair of the Commission. Press release: http://bit.ly/2Kod7a3

Payment and Delivery System Reform –

  • On May 10, CMS released several documents related to the new Medicare Diabetes Prevention Program, including a fact sheet focused on Medicare Advantage and an updated set of FAQs. Fact sheet: http://bit.ly/2KfeFD2 FAQ: http://bit.ly/2wxMZqX

Mental Health and Substance Abuse –

  • On May 7, Substance Abuse and Mental Health Services Administration (SAMHSA) announced the availability of up to $23.4 million over the next five years in grants for the Infant and Early Childhood Mental Health Grant Program. Applications are due by June 29. Press release: http://bit.ly/2wEv1mX
  • On May 9, SAMHSA released a report finding that 46 percent of children in the U.S. report having experienced at least one traumatic event in their lifetime. Press release: http://bit.ly/2K7ArZa Report: http://bit.ly/2K8trLW
  • On May 9, Food and Drug Commissioner Gottlieb penned a blog post about the FDA’s regulation of the use of loperamide, which is sold over the counter, and is sometimes used to create an opioid-like high. Blog post: http://bit.ly/2sjaaDj
  • On May 10, Senate Homeland Security and Government Affairs Committee Ranking Member McCaskill (D-MO) released a report showing that the amount of illicit fentanyl seized by the Department of Homeland Security has increased dramatically, and that the overwhelming majority of fentanyl seizures are occurring at ports of entry. Press release: http://bit.ly/2rzTR28  Report: http://bit.ly/2rw8SlF
  • Also on May 10, Centers for Disease Control and Prevention (CDC) and SAMHSA released a joint report finding that about half of mental health and a third of substance abuse treatment facilities reported having smoke-free campuses. Report: http://bit.ly/2rAuaOW
  • Also on May 10, National Institutes of Health announced a new discovery that opioids used to treat pain, such as morphine and oxycodone, produce their effects by binding to receptors inside neurons, contrary to convention wisdom that they acted only on the same surface receptors as endogenous opioids. Press release: http://bit.ly/2rwbaBh

Drugs and Medical Device Regulation

  • On May 7, Sens. Warren (D-MA) and Cassidy (R-LA) sent a letter to Food and Drug Administration (FDA) Commissioner Gottlieb expressing interest in the timely completion of the FDA’s forthcoming report on medical device servicing. Press release: http://bit.ly/2wrLmet Letter: http://bit.ly/2K82bNi
  • On May 9, Affordable Prescription Drug Task Force co-chairs Reps. Welch (D-VT) and Doggett (D-TX) released a list of key provisions they believe that the Administration’s drug pricing plan should include. Press release: http://bit.ly/2Ivgqi3
  • Also on May 9, FDA Commissioner Gottlieb released a statement about the FDA’s upcoming regulatory actions, as included in the Administration’s Spring 2018 Unified Agenda. The FDA plans to focus on addressing the nicotine addiction crisis, modernizing and harmonizing standards, and enhancing clinical trial processes. Blog post: http://bit.ly/2ItfXgl
  • On May 11, President Trump announced a plan to lower drug prices, the American Patients First Blueprint, which directs HHS to take several steps to boost competition and streamline approval processes, encourage value-based pricing, work to give Part D plan sponsors more negotiation power and examine which Part B drugs could be moved to Part D, and increase drug price transparency, among other proposals. The blueprint also seeks feedback about other potential administrative actions on drug pricing and budget proposals requiring legislative action. President Trump’s speech: http://bit.ly/2IyR1nM HHS press release: http://bit.ly/2ID9mjr CMS Press release: https://go.cms.gov/2IF2B0L FDA Press release: http://bit.ly/2IC2OBO Op-ed by HHS Secretary Azar and CMS Administrator Verma: http://bit.ly/2IBAsHT Fact sheet: http://bit.ly/2IESTLI Blueprint: http://bit.ly/2IF96Rg
  • Also on May 11, House Committee on Oversight & Government Affairs Ranking Member Cummings (D-MD) released a report documenting “huge price increases imposed by drug companies” during President’s Trump’s time in office. Press release: http://bit.ly/2IyXwHl  Report: http://bit.ly/2IDt8eN

 Military & Veterans’ Health –

  • On May 7, U.S. Government Accountability Office (GAO) released a report on the VA’s oversight of agency researchers, finding that the VA has taken steps to educate agency researchers about its requirements to disclose inventions to VA, but researchers have not consistently done so. Summary with link to report: http://bit.ly/2Iu9nq1
  • On May 10, VA issued a final rule to standardize the delivery of care by VA health care providers through telehealth. Press release: http://bit.ly/2wwE8FU Final rule: http://bit.ly/2rAGzT1
  • Also on May 10, VA issued a notice announcing that it projects it will exhaust appropriated funding for the Veterans Choice program sometime between May 31 and June 15, 2018. Notice: http://bit.ly/2rzO1h4
  • Also on May 10, VA adopted as final an interim final rule revising its medical regulations that implement section 101 of the Veterans Choice Act. Final rule: http://bit.ly/2rz0CBm

 Misc. –

  • On May 8, CMS announced a new Rural Health Strategy intended to “provide a proactive approach on healthcare issues.” The strategy seeks to (1) apply a rural lens to CMS programs and policies, (2) improve access to care through provider engagement and support, (3) advance telehealth and telemedicine, (4) empower patients in rural communities to make decisions about their health care, and (5) leverage partnerships to achieve the goals of the CMS Rural Health Strategy. Press release: https://go.cms.gov/2KbAjIf  Fact sheet: https://go.cms.gov/2wvaRf3 New website: https://go.cms.gov/2K8q8V2
  • On May 10, GAO released a report on the HHS Office of Inspector General’s use of agreements to protect the integrity of federal health care programs, including Corporate Integrity Agreements and Integrity Agreements. Summary with link to report: http://bit.ly/2IrE4fD Supplemental material: http://bit.ly/2IrE5QJ
  • On May 11, Centers for Disease Control and Prevention (CDC) released a report finding that deaths from unintentional injuries are the seventh leading cause of death among older adults, and falls accounts for the largest percentage of those deaths. Report: http://bit.ly/2rzJXgP