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


What’s Ahead: This Week

 

Hearings and Markups –

  • Wednesday, December 19
    • House and Senate Veterans’ Affairs Committees, “Tracking Transformation: VA MISSION Act Implementation.”
  • Thursday, December 20
    • House Veterans Affairs Committee, Subcommittee on Oversight and Investigations, “The Veterans First Program after Kingdomware.”

 Notable Policy Events –

  • Tuesday, December 18
    • HHS, “News Conference: Surgeon General’s Advisory on E-Cigarette Use Among Youth.” Additional information: https://bit.ly/2kipx7Y
    • HHS, “Innovation and Investment Summit.”

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

 

Committee Memberships –

  • On December 11, the House Democratic Steering and Policy Committee announced chairmanships for the 116th Appropriations: Rep. Lowey (D-NY); Energy and Commerce: Rep. Pallone (D-NJ); Financial Services: Rep. Waters (D-CA); Ways and Means: Rep. Neal (D-MA). Press release: https://bit.ly/2Blxe5I
  • On December 13, Senate Minority Leader Schumer announced Senate Democratic committee memberships for the 116th Full list: https://bit.ly/2zZqCdq

 Legislative Activity –

  • On December 10, the House passed by a voice vote the Veterans Benefits and Transition Act of 2018 (S. 2248), which would authorize the Secretary of Veterans Affairs to provide certain burial benefits for spouses and children of veterans, and would aid student veterans that use the Forever GI bill. Having previously passed the Senate, the bill now moves to the President for signature. Press release: http://bit.ly/2QS9Vu5 Bill text: http://bit.ly/2QWDhaA
  • Also on December 10, Rep. Castor (D-FL) introduced the Creating Access to Residency Education Act of 2018 (H.R. 7233), which would authorize grants for graduate medical education partnerships in states with a low ratio of medical residents relative to the general population. Text: https://bit.ly/2LhqBWB
  • Also on December 10, House Ways & Means Committee Chair Brady (R-TX) introduced the Retirement, Savings, and Other Tax Relief Act of 2018 (H.R. 88), which includes a number of tax privisions, but which would also delay the medical device tax, the health insurance tax, and the Cadillac Tax. Press release: http://bit.ly/2Erwjnz Bill text: http://bit.ly/2Epa7dt
  • On December 11, the House passed by a vote of 400-11 the IMPROVE Act (H.R. 7217), which would impose civil penalties on drug manufacturers that knowingly misclassify drugs, among other things. The measure now moves to the Senate for consideration. Press release: https://bit.ly/2SRMEWi Text: https://bit.ly/2Exe1BZ
  • Also on December 11, the House passed by voice vote the Traumatic Brain Injury Program Reauthorization Act of 2018 (H.R. 6615), which would reauthorize the Traumatic Brain Injury Program. The measure now moves to the Senate for consideration. Press release: https://bit.ly/2Ba5aSH Text: https://bit.ly/2LgEXXk
  • Also on December 11, the House passed by a voice vote the Sickle Cell Disease and Other Heritable Blood Disorders Research, Surveillance, Prevention, and Treatment Act of 2018 (S. 2465), which would reauthorize a sickle cell disease prevention and treatment demonstration program and to provide for sickle cell disease research, surveillance, prevention, and treatment. Having previously passed the House, the measure now moves to the President for approval. Press release: https://bit.ly/2BiZ2Yv Text: https://bit.ly/2SQ2m4s
  • Also on December 11, the House passed by a vote of 406-3 the PREEMIE Reauthorization Act (S. 3029), which would revise and extend the Prematurity Research Expansion and Education for Mothers who deliver Infants Early Act. Having previously passed the Senate, the measure now moves to the President for approval. Press release: https://bit.ly/2Bm9KNX Text: https://bit.ly/2EtX8YZ
  • Also on December 11, the Senate passed by unanimous consent the Emergency Medical Services for Children Program Reauthorization Act of 2018 (S. 3482), which would reauthorize the Emergency Medical Services for Children program. The measure now moves to the House for consideration. Text: https://bit.ly/2rB1iph
  • Also on December 11, House Ways and Means Committee Chair Brady (R-TX) and Shimkus (R-IL) introduced the Incentivizing Shared Risk in Medicare Advantage Act (H.R. 7247), which would clarify the authority of Medicare Advantage (MA) organizations to provide waivers from MA plans’ prior authorization requirements. Press release: https://bit.ly/2SLpW24 Text: https://bit.ly/2Enf6LF
  • Also on December 11, Rep. Marchant (R-TX) and Rep. Sewell (D-AL) introduced the Reducing Administrative Burden and Becoming Increasingly Transparent Act (H.R. 7248), which would direct the Secretary of HHS to solicit information from providers and suppliers of services on ways to reduce administrative and regulatory burdens under the Medicare program. Press release: https://bit.ly/2SLpW24 Text: https://bit.ly/2PDefsz
  • Also on December 11, Rep. Reed (R-NY) introduced the Better Prior Authorization Notification Act (H.R. 7249), which would require MA plans to provide physicians and other providers with information on items and services that are subject to a prior authorization, beginning in contact year 2021. Press release: https://bit.ly/2SLpW24 Text: https://bit.ly/2zXI1D8
  • Also on December 11, Rep. Kelly (R-PA) and House Energy and Commerce Health Subcommittee Vice Chair Guthrie (R-KY) introduced the Prior Authorization Improvement Act (H.R. 7250), which would direct the Secretary of HHS to conduct a study and submit to Congress a report on the feasibility of using certain technologies to facilitate the administration of prior authorization requirements in MA. Press release: https://bit.ly/2SLpW24
  • Also on December 11, Rep. Smith (R-MO) introduced the Remove Extraneous Measures that Obstruct Value and Efficiency (REMOVE) Act (H.R. 7253), which would provide for consideration of the removal of certain measures applicable to inpatient hospitals and post-acute care inpatient providers in an effort to minimize costs and burdens. Press release: https://bit.ly/2SLpW24
  • Also on December 11, Sen. Cassidy (R-LA) introduced the Veterans Affairs Medical-Surgical Purchasing Stabilization Act (S. 3737), which would direct the Secretary of Veterans Affairs (VA) to carry out the Medical Surgical Prime Vendor program using multiple prime vendors. Press release: https://bit.ly/2Cei0RG Text: https://bit.ly/2rKp02N
  • Also on December 11, Senate Finance Committee Chair Hatch (R-UT) and Sen. Tillis (R-NC) introduced the Hatch-Waxman Integrity Act of 2018 (S. 3738), which would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between the Hatch-Waxman framework and inter parties review (IPR). Rep. Flores (R-TX) introduced companion legislation in the House. Press release: https://bit.ly/2QWEBu0 Text: https://bit.ly/2QVNHHm
  • On December 12, the Senate passed by unanimous consent the Congenital Heart Futures Reauthorization Act of 2017 (H.R. 1222), which would enhance and expand research and data collection efforts related to congenital heart disease, including to study and track the epidemiology of congenital heart disease to understand health outcomes for individuals with congenital heart disease across all ages. The measure now moves to the president for approval. Text:  https://bit.ly/2GiiPwH
  • Also on December 12, the Senate passed by voice vote the BOLD Infrastructure for Alzheimer’s Act (S. 2076), 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. The measure now moves the House for consideration. Press release: https://bit.ly/2zZ0LC9 Text: https://bit.ly/2QtyDl3
  • Also on December 12, Sens. Smith (D-MN), Moran (R-KS), Murphy (D-CT), and Wicker (R-MS) introduced the Cancer Drug Parity Act (S. 3742), which would require group and individual health insurance coverage and group health plans to provide for cost sharing for oral anticancer drugs on terms no less favorable than the cost sharing provided for anticancer medications administered by a health care provider. Press release: https://bit.ly/2GbyVsc Text: https://bit.ly/2S2b5Ak
  • On December 13, the Senate passed by unanimous consent the Preventing Maternal Deaths Act of 2018 (H.R. 1318), which would establish a grant program for states to review maternal mortality findings and develop recommendations. Having previously passed the House, the bill now moves to the president for approval. Press release: https://bit.ly/2CbCMBe Text: https://bit.ly/2QRRoxL
  • Also on December 13, Rep. Foster (D-IL) led a group of six bipartisan congressmen in introducing the Medical Records Access Fairness Act (H.R. 7295), which would amend the HITECH Act to allow an individual to obtain a copy of such individual’s protected health information at no cost in certain circumstances. Press release: https://bit.ly/2zV9rJS Text: https://bit.ly/2SRNz9v
  • Also on December 13, Sens. Blumenthal (D-CT), Harris (D-CA), Merkley (D-OR), and Klobuchar (D-MN) introduced the CURE High Drug Prices Act (S. 3754), which would require pharmaceutical companies to submit justification to HHS for any price increases of 10 percent or more over the preceding year; 20 percent or more over the preceding three years; and 30 percent or more over the preceding five years. Press release: https://bit.ly/2Em3vws Text: https://bit.ly/2QwkeEB
  • On December 14, Rep. Foster (D-IL) introduced the Medical Records Access Fairness Act (H.R. 7295), which would amend the HITECH Act to allow an individual to obtain a copy of such individual’s protected health information at no cost in certain circumstances. Press release: http://bit.ly/2QYSW9f Bill text: http://bit.ly/2QYwxZX

 

ACA and Individual Insurance Markets –

  • On December 10, Sen. Cortez Masto (D-NV) penned a letter to CMS Administrator Verma requesting information about the agency’s removal of document containing best practices for Latino community outreach from its health insurance marketplace website. Press release: https://bit.ly/2Cg0s7B Letter: https://bit.ly/2QYSsA4
  • On December 11, CMS issued a statement on 2019 Health Insurance Exchange Open Enrollment, noting that the agency will individuals to enroll after the December 15 deadline if enrollment assisters are busy at the time of their call. Press release: https://go.cms.gov/2SRpX4N
  • Also on December 11, Department of Treasury released the methodology for calculation of section 1332 waiver premium tax credit pass-through amounts. Methodology: https://go.cms.gov/2UEpq80
  • On December 12, twelve Republican governors wrote to Senate Majority Leader McConnell (R-KY) and House Speaker Ryan (R-WI) in opposition to the Health Insurance Premium Tax (HIT) and the Medical Device Tax (MDT), urging Congress to permanently repeal both taxes before the holidays. Letter: https://bit.ly/2rBliIx
  • On December 13, CMS released a Weekly Enrollment Snapshot for the sixth week of the 2019 Open Enrollment period, showing that 934,269 individuals selected plans using the HealthCare.gov platform, for a total of 4.13 million. Fact sheet: https://go.cms.gov/2QOEYqH
  • On December 14, the U.S. District Court Judge O’Conner released a decision in the Texas vs. Azar case, finding that the ACA is unconstitutional, and striking down the law in its entirety. The ruling is expected to be appealed and does not have any immediate impact. Decision: http://bit.ly/2EpQBNW

 Medicare –

  • On December 13, U.S. Government Accountability Office (GAO) released a report investigating Medicare payments for certain long-term care hospitals that specialize in spinal cord treatment. Summary with link to report: https://bit.ly/2EnLCxA

 Medicaid –

  • On December 11, HHS Office of Inspector General (OIG) released a report finding that CMS had not recovered more than $1 billion in Medicaid overpayments identified by OIG audits, and recommending that CMS recover the remaining $1.6 billion due the federal government from the current period and $188.6 million due the federal government from the prior period. Summary with link to report: https://bit.ly/2CcVpoC

 Payment and Delivery System Reform –

  • On December 11, CMS posted a fact sheet comparing the key model elements for the Integrated Care for Kids (InCK) and Maternal Opioid Misuse (MOM) models. Fact sheet: https://bit.ly/2QwowvH

 Substance Use and Mental Health –

  • On December 10, U.S. Food and Drug Administration (FDA) cleared a mobile medical app to help those with opioid use disorder (OUD) stay in recovery programs. Press release: https://bit.ly/2EmpnbT
  • On December 12, Centers for Disease Control and Prevention (CDC) published a study finding that that the drugs most frequently involved in drug overdose deaths in the U.S. between 2011 and 2016 were opioids, benzodiazepines, and stimulants. Study: https://bit.ly/2EoYDrv
  • On December 13, U.S. Preventive Service Task Force (USPSTF) released a request for comment on a draft research plan to study patient- and clinical-level interventions to prevent opioid use disorder. Comments are due by January 16. Link to draft research plan: http://bit.ly/2EnEbWZ

 Drug and Medical Device Prices and Regulation –

  • On December 11, FDA released a series of new guidance documents as a part of its Biosimilars Action Plan, an effort to bring biosimilar drugs to market more quickly and efficiently. FDA Commissioner Gottlieb statement: https://bit.ly/2Ggr38N Link to list of guidance documents: https://bit.ly/2Epxd3J
  • On December 12, FDA Commissioner Gottlieb released a statement on the agency’s efforts to improve drug quality through vigilant oversight of data integrity and good manufacturing practice. Statement: https://bit.ly/2SPPATA
  • On December 13, Sen. Baldwin (D-WI) penned a letter to Pfizer CEO Ian Read, calling on the company to provide an explanation after the announcement of intended price increases of 41 prescription drugs beginning in January 2019. Press release: https://bit.ly/2PDE3Vf Letter: https://bit.ly/2Cg6Snl
  • Also on December 13, FDA released a report on non-device software functions’ impact to health and best practices, finding that the health software products that Congress ordered FDA not to regulate have benefits that outweigh their risks. Report: https://bit.ly/2PAEhwh

 Military & Veterans’ Health –

  • On December 10, Department of Veterans Affairs (VA) updated portions of the VA Schedule for Rating Disabilities (VASRD) that evaluations the hematologic and lymphatic systems. Press release: https://bit.ly/2E59iqd
  • Also on December 10, House Veterans’ Affairs Committee Ranking Member Walz (D-MN) penned a letter to VA Secretary Wilkie regarding the need for transparency in decision making at VA. Press release: https://bit.ly/2rFcAJc Letter: https://bit.ly/2SNXsVy
  • On December 11, VA OIG released a report on major management challenges at VA in 2018, including:(1) leadership and workforce investment, (2) healthcare delivery, (3) benefits delivery, (4) financial management, (5) procurement practices, and (6) information management. Report: https://bit.ly/2rEasld
  • On December 12, VA announced that it is funding 10 VA Patient Safety Centers of Inquiry (PSCI) over the next three years to develop innovations to improve patient safety throughout VA. Press release: https://bit.ly/2zSHHWn
  • Also on December 12, GAO released a report finding that planning gaps could impede readiness for successful appeals implementation at VA. Summary with link to report: https://bit.ly/2EvlCAS
  • On December 13, VA announced that a Dartmouth study published in Annals of Internal Medicine found that VA hospitals outperform private hospitals in most health care markets throughout the country. Press release: https://bit.ly/2rBdSoB

 Health Data and IT –

  • On December 12, HHS released a request for information (RFI) seeking public input on improving care coordination and reducing the regulatory burdens through potential revisions to the Health Insurance Portability and Accountability Act (HIPAA). Comments are due by February 11. Press release: https://bit.ly/2QSd0Kp RFI: https://bit.ly/2QMMKRF
  • Also on December 12, HHS released a report entitled “Using Telehealth to Identify and Manage Health and Substance Use Disorder Conditions in Rural Areas.” The report found that telehealth can support behavioral health, specifically SUD treatment, in a variety of ways, including direct patient care, patient engagement, and provider education Summary with link to report: https://bit.ly/2CftR1X

 Misc. –

  • On December 11, HHS announced that clients receiving Ryan White HIV/AIDS Program medical care were virally suppressed at a record level – 85.9 percent – in 2017. Press release: https://bit.ly/2Qz2fxm
  • Also on December 11, Senate HELP Committee Chair Alexander (R-TN) penned letters to the American Enterprise Institute (AEI), the Brookings Institution, and other healthcare stakeholders asking for ideas about how to reduce health care costs. Press release: https://bit.ly/2GkJXLB Letter: https://bit.ly/2Em5noT