Health Care Policy Update – Weekly Wrap-up and What’s Ahead


 What’s Ahead: This Week

 Hearings/Markups –

  • Tuesday, July 17
    • Senate HELP Committee, “Reducing Health Care Costs: Eliminating Excess Health Care Spending and Improving Quality and Value for Patients.”
    • House Energy & Commerce Committee, Subcommittee on Oversight and Investigations, “Examining State Efforts to Improve Transparency of Health Care Costs for Consumers.”
    • House Ways & Means Committee, Subcommittee on Oversight, “Combating Fraud in Medicare: A Strategy for Success.”
    • House Ways & Means Committee, Subcommittee on Health, “Modernizing Stark Law to Ensure the Successful Transition from Volume to Value in the Medicare Program.”
    • House Veterans Affairs Committee, Subcommittee on Oversight, “The VA Accountability and Whistleblower Protection Act: One Year Later.”
  • Wednesday, July 18
    • Senate Aging Committee, “Supporting Economic Stability and Self-Sufficiency as Americans with Disabilities and their Families Age.”
  • Thursday, July 19
    • House Energy & Commerce Committee, Subcommittee on Health, “21st Century Cures Implementation: Examining Mental Health Initiatives.”

 Notable Policy Events –

  • Monday, July 16
    • Pew Charitable Trusts, “Addressing Rising Drug Prices.” Additional information: https://bit.ly/2LdyG0K
    • National Academies of Sciences, Engineering, and Medicine (NASEM), “Integrating Social Needs Care into the Delivery of Health Care to Improve the Nation’s Health.” Additional information: http://bit.ly/2JpRhlt
  • Tuesday, July 17
    • The Atlantic, “The State of Care: Innovation and Access.” Additional information: https://bit.ly/2N5T15s
    • Politico, “Pro Summit.” Additional information: https://politi.co/2MnddzA
    • Healthcare Leadership Council, “Ensuring Patient Safety through Evidence-Based Medicine.”
    • The Atlantic, “The State of Care: Innovation and Access.” Additional information: http://bit.ly/2LqflGQ
  • Wednesday, July 18
    • Brookings Institution, “Cultivating a Vibrant U.S. Market for Biosimilars.” Additional information: https://brook.gs/2KWhEAW
  • Thursday, July 19
    • National Coalition on Health Care, “Tackling Prescription Drug Costs: An Examination of Proposed Medicare Part D Reforms and Alternatives.”
    • NASEM, “Integrating Health Care and Social Services for People with Serious Illness: A Workshop.” Additional information: http://bit.ly/2Jn30B7
  • Friday, July 20
    • USC-Brookings Schaeffer Initiative for Health Policy, “Can the Merit-Based Incentive Payment System (MIPS) Be Salvaged?” Additional information: https://brook.gs/2uh6qAC
    • Alliance for Health Policy and The Commonwealth Fund, “State Responses to the Evolving Individual Health Insurance Market.” Additional information: https://conta.cc/2NKHppE

                                 

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

 Administration –

  • On July 10, Senate Veterans Affairs Committee approved by voice vote Robert Wilkie’s nomination to be Secretary of the Department of Veterans Affairs. The pending nomination now moves to the full Senate for consideration. Press release: http://bit.ly/2LeObWA

 Appropriations –

  • On July 11, House Appropriations Committee approved by a vote of 30-22 the draft fiscal year (FY) 2019 Labor, Health and Human Services, and Education appropriations bill, which would provide $89.2 billion in discretionary funding for HHS, an increase of $1 billion from the FY2018 enacted level. The bill now moves to the full House for consideration. Press release: http://bit.ly/2LbXmXB Summary: http://bit.ly/2HXMLK0 Report: http://bit.ly/2LbXyWP Bill text: http://bit.ly/2LbXKFx

 Legislative Activity –

  • On July 11 and 12, House Ways & Means Committee voted to approve and favorably report 11 bills related to health savings accounts and ACA taxes to the full House for consideration. Bills: https://bit.ly/2zDnG8w
  • Also on July 11, Reps. Rosen (D-NV) and Welch (D-VT) introduced the Capping Prescription Costs Act of 2018 (H.R. 6340), which would place a monthly cap on out-of-pocket drug costs for individuals and families covered by ACA exchange plans or any group health plan. Sens. Warren (D-MA), Nelson (D-FL), Wyden (D-OR), and Murray (D-WA) introduced companion legislation in the Senate (S. 3194). Press release: https://bit.ly/2NLnNlz Text: https://bit.ly/2upTVlI
  • Also on July 11, Reps. Walz (D-MN) and Peterson (D-MN) introduced the Protect Medicare for Seniors Act of 2018 (H.R. 6341), which would delay the transition Medicare Cost plan beneficiaries to Medicare Advantage plans from 2019 to 2021. Press release: https://bit.ly/2L58xBk Text: https://bit.ly/2NepJ4V
  • Also on July 11, Sens. Collins (R-ME) and Cardin (D-MD) introduced the Increasing Access to Osteoporosis Testing for Medicare Beneficiaries Act of 2018 (S. 3160), which would restore reimbursement under Medicare Part B for bone mass measurement using dual-energy X-ray absorptiometry (DXA) services to 70 percent of 2006 levels. Press release: https://bit.ly/2KYcU24
  • On July 12, Rep. Huizenga (R-MI) introduced the Increasing National Patient Access to Improved Effective Necessary Mental Health Treatment (INPATIENT) Act of 2018 (H.R. 6343), which would establish a demonstration program for qualified mental health providers to optimize federal resources for hard-to-reach and costly patient populations. Press release: https://bit.ly/2LfOk8T
  • Also on July 12, Senate HELP Committee Ranking Member Murray (D-WA) and Sen. Murkowski (R-AK) introduced the Survivors’ Access to Supportive Care Act (SASCA) (S. 3203), which would direct HHS to establish a national training and continuing education pilot program to expand access to health care for survivors of sexual assault by developing federal standards around examinations and treatment. Press release: https://bit.ly/2LctsPS Text: https://bit.ly/2NLeBNM

 ACA Implementation –                                      

  • On July 9, CMS issued a summary report on permanent risk adjustment transfers for the 2017 benefit year. However, CMS previously announced that it is suspending risk adjustment payments pending the outcome of an ongoing court case, and on July 12, CMS released guidance on the implications of the case on current risk adjustment programs. Report: https://bit.ly/2N3cvrl Guidance: https://go.cms.gov/2Lal8TJ
  • Also on July 9, House Oversight & Government Reform Committee Ranking Member Cummings (D-MD) sent a letter to Chair Gowdy (R-SC) asking him to issue a subpoena to compel the Department of Justice to produce documents relating to the Administration’s decision to argue in federal court that key provisions of the Affordable Care Act are unconstitutional. Press release: https://bit.ly/2LcQqpL Letter: https://bit.ly/2zCrVB3
  • On July 10, CMS announced that it is providing $10 million in funding for the Federally-Facilitated Exchange Navigator Program for the 2019 Open Enrollment period, a decrease from the $36 million granted for the 2018 Open Enrollment period. Press release: https://go.cms.gov/2ul57zX Statements from Senate Finance Committee Ranking Member Wyden (D-OR), Senate HELP Committee Ranking Member Murray (D-WA), and House Energy & Commerce Committee Ranking Member Pallone: http://bit.ly/2L7ju5v and http://bit.ly/2Lc738k and http://bit.ly/2LeeX0W
  • On July 12, leaders of 10 state-based health insurance exchanges sent a letter to HHS Secretary Azar and CMS Administrator Verma, urging them to defend the ACA’s risk adjustment program in federal court and to clarify publicly that the New Mexico litigation does not relate to CMS’ implementation of the risk adjustment program for the 2019 benefit year. Letter: https://bit.ly/2JlsKhb
  • On July 13, CMS deemed complete and released for public comment New Jersey’s section 1332 State Innovation Waiver application, which would establish a reinsurance program in the state. Comments are due by August 12. Letter: https://go.cms.gov/2L6j0fN Waiver: http://bit.ly/2KYgh8l

 Medicare –

  • On July 10, HHS Office of Inspector General (OIG) released a report showing that Medicare improperly paid $6.7 million to providers for items and services ordered by chiropractors between CY13 and CY16 that did not comply with federal requirements. Summary: https://bit.ly/2NL3tjY Report: https://bit.ly/2LdSzl4
  • On July 11, CMS issued a proposed rule modifying the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to beneficiaries on or after January 1, 2019, which would increase the base rate by $3.45 to $235.82. The proposed rule also updates the acute kidney injury (AKI) dialysis payment rate, the ESRD Quality Incentive Program (QIP), and payment rules for Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS). Comments are due by September 10. Press release: https://go.cms.gov/2zIgJTs Fact sheet: https://go.cms.gov/2KWL3zj Proposed rule: https://bit.ly/2JfuEQA
  • On July 12, CMS released proposed updates to the Medicare Physician Fee Schedule (PFS) and Quality Payment Program (QPP) for calendar year 2019, which would address the agency’s “Patients Over Paperwork” initiative, expand telehealth reimbursement, and make changes the Medicare Part B drug reimbursement formula, among other proposals. Comments are due by September 10. Press release: https://go.cms.gov/2KPovjC PFS fact sheet: https://go.cms.gov/2zyCplb  QPP fact sheet: https://go.cms.gov/2KTGKo3 Proposed rule: https://bit.ly/2LfoBNX
  • Also on July 12, CMS announced the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration, which is designed to test whether exempting MIPS-eligible clinicians who participate in payment arrangements with Medicare Advantage Organizations (MAOs) from MIPS reporting requirements and payment adjustment will increase or maintain participation in similar Advanced APMs with MAOs. Fact sheet: https://go.cms.gov/2zxDHww Demonstration website: http://bit.ly/2L8gnKl
  • On July 13, HHS OIG released a report finding that while the Medicare Drug Integrity Contractor MEDIC) has helped to cover $3 for every $1 invested in 2017, CMS has no measures that specifically assess the MEDIC’s effectiveness. Summary with link to report: http://bit.ly/2LlcQoU

 Medicaid –

  • On July 10, CMS issued a proposed rule amending current Medicaid regulations that allow a state to make payments to third parties on behalf of an individual for benefits such as health insurance, skills training, and other benefits customary for employees. Comments are due by August 13. Fact sheet: https://go.cms.gov/2N7qNrj Proposed rule: https://bit.ly/2mgoxlO
  • Also on July 10, Rep. Yarmuth (D-KY) sent a letter to HHS Secretary Azar requesting information about whether Kentucky Governor Bevin had sufficient authority to make changes to the state’s Medicaid program without public notification or HHS approval. Press release: http://bit.ly/2L8xnjO Letter: http://bit.ly/2Lc27Ar
  • On July 12, White House Council of Economic Advisers (CEA) released a report describing the current authority for work requirements in non-cash welfare programs, and providing justification for their expansion. Report: https://bit.ly/2L3DYfn
  • Also on July 12, HHS OIG released a report finding that weaknesses exist in Medicaid managed care organizations’ efforts to identify fraud and abuse. Summary with link to report: http://bit.ly/2Lh9Utz

 Mental Health and Substance Use –

  • On July 9, Food and Drug Administration (FDA) Commissioner Gottlieb issued a statement on balancing access to appropriate treatment for patients with chronic and end-of-life pain with the need to take steps to stem the misuse and abuse of opioids. Statement: https://bit.ly/2zo7Q1n
  • On July 10, Substance Abuse and Mental Health Services Administration (SAMHSA) announced that it will host the second Federal Commission on School Safety meeting which will focus on behavioral health integration in schools. Press release: http://bit.ly/2Lbxuev
  • Also on July 10, HHS OIG released a report finding extreme use and overprescribing of opioids in the Ohio Medicaid program. Summary with link to report: http://bit.ly/2L51Tex
  • Also on July 10, Sens. Collins (R-ME), Casey (D-PA), and Donnelly (D-IN) penned a letter to Comptroller General Dodaro requesting that GAO evaluate the relationships between labor force participation rates of prime-age and older workers and substance use disorders, as well as linkages with state and federal policies. Press release: https://bit.ly/2Lf0dMg Letter: https://bit.ly/2NPGHaS
  • On July 11, Department of Justice (DoJ) announced the a final rule allowing the Drug Enforcement Administration’s (DEA) to reduce the amount of opioids that can be produced in a given year if they believe that a particular company’s opioids are being diverted for misuse. Press release: https://bit.ly/2LeZDOA Final rule: https://bit.ly/2NfmrOR
  • On July 12, Sen. McCaskill (D-MO) released a report showing that 1.6 billion doses of opioids entered the state of Missouri between 2012 and 2017. Press release: https://bit.ly/2N9L8w3 Report: https://bit.ly/2L4m7VG
  • On July 13, Attorney General Sessions announced a new program, Operation Synthetic Opioid Surge, which seeks to reduce the supply of deadly synthetic opioids in high impact areas and to identify wholesale distribution networks and international and domestic suppliers. Press release: http://bit.ly/2L7pfjD
  • Also on July 13, Centers for Disease Control and Prevention (CDC) released a report with data on overdose deaths due to carfentanil and other fentanyl analogs detected in 10 states between July 2016 and June 2017. Among 11,045 opioid deaths within that timeframe, 20.6% of decedents tested positive for any fentanyl analog. Report: https://bit.ly/2Las7Mx

Drug Prices and Regulation –

  • On July 9, House Energy & Commerce Committee Ranking Member Pallone (D-NJ) sent a letter to Committee Chair Walden (R-OR) and Health Subcommittee Chair Burgess (R-TX) requesting a hearing to examine the potential misuse of the Risk Evaluation and Mitigation Strategies (REMS) program by pharmaceutical manufacturers. Press release: https://bit.ly/2LfCKum Letter: https://bit.ly/2zCLsBt
  • On July 10, Pfizer announced that it is deferring certain planned drug price increases until a later date following a conversation with President Trump and HHS Secretary Azar. The same day, Senate Finance Committee Ranking Member Wyden (D-OR) sent a letter to HHS Secretary Azar and Pfizer, requesting additional information about what was agreed to and when the price delays will go into effect. CMS Administrator Verma statement: https://go.cms.gov/2Ndhztv HHS Secretary Azar statement: https://bit.ly/2ussbgr Senate Finance Committee Ranking Member Wyden (D-OR) statement and letter https://bit.ly/2L4z1D9 and https://bit.ly/2LgcwrN
  • Also on July 10, FDA Commissioner Gottlieb released a blog post highlighting the FDA’s commitment to developing new tools to access and use data from all sources, including real world data. Blog post: http://bit.ly/2L6nHpV
  • On July 11, FDA Commissioner Gottlieb issued a statement on the agency’s efforts to advance the development of gene therapies. The statement was coupled with a suite of six scientific guidance documents for safe and effective gene therapies. Statement: https://bit.ly/2NK6pgH
  • Also on July 11, U.S. Government Accountability Office (GAO) released a report on the 340B drug discount program, finding weaknesses in HHS’ oversight impeding its ability to ensure compliance with 340B program requirements. Summary: https://bit.ly/2uj18oj Report: https://bit.ly/2KTjRRO
  • On July 12, FDA Commissioner Gottlieb issued a statement on the formation of a new drug shortages taskforce and the agency’s efforts to advance long-term solutions to prevent drug shortages. Statement: https://bit.ly/2uwn52O

Military & Veterans’ Health –

  • On July 10, VA announced that it has formed a partnership with the National Cancer Institute (NCI) to provide more access to the latest treatment options for VA patients with cancer. Press release: https://bit.ly/2umVpNp
  • Also on July 10, FDA announced that an emergency use authorization has been granted to U.S. Department of Defense (DoD) to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma for military service members. Press release: https://bit.ly/2uq51YX
  • On July 11, VA announced that it recently issued a record number of decisions for veterans appealing their disability benefits claims after implementing a new interactive decision template and a specialty case team. Press release: https://bit.ly/2LisVM3
  • On July 12, VA announced the recent establishment of the Office of Electronic Health Record Modernization (OEHRM). The office will manage the preparation, deployment, and maintenance of VA’s new electronic health record system and the health IT tools dependent upon it. Press release: https://bit.ly/2NegGkj
  • Also on July 12, House Veterans Affairs Committee announced the creation of a new Subcommittee on Technology Modernization, which is charged with overseeing the VA’s technology projects, including the EHR modernization effort. Press release: http://bit.ly/2L7kab3

 Health IT –

  • On July 10, Office of the National Coordinator for Health IT (ONC) announced the office’s Certified Health IT Product List (CHPL) Data Challenge, which seeks to encourage software developers to make use of data on certified health IT in ways that can enrich providers, consumers, and the IT community’s understanding of certified health IT. Submissions are due October 31, 2018. Link: https://bit.ly/2uz4iDK
  • On July 11, FCC Commissioner Carr and Sen. Wicker (R-MS) announced that the FCC will seek to establish a new $100 million Connected Care Pilot Program to support telehealth for low-income Americans, especially veterans and those living in rural areas. Press release: https://bit.ly/2N65R3R

Misc. –

  • On July 9, House Oversight & Government Reform Committee Ranking Member Cummings (D-MD) sent a letter to Chair Gowdy (R-SC) asking him to issue a subpoena to compel HHS to produce documents relating to the so-called ‘gag rule’ it has proposed for the Title X National Family Planning Program. Press release: https://bit.ly/2KRIbDu Letter: https://bit.ly/2L85w3m
  • On July 11, HHS announced that two potential diagnostic tests for influenza designed to be purchased over-the-counter for home use will move into advanced development. Press release: https://bit.ly/2KRClSz
  • On July 12, Sens. Durbin (D-IL) and Duckworth (D-IL) and Rep. Kelly (D-IL) led a group of 23 senators and 11 representatives in a letter to health insurers requesting information about the pregnancy and postpartum services covered by their plans, in order to reduce racial disparities in maternal and infant health outcomes. Press release: http://bit.ly/2L8bLnv
  • On July 13, HHS released a report on the number of families that might be newly reached by child support cooperation requirements in SNAP and subsidized child care. Report: https://bit.ly/2uuuCil