What’s Ahead: This Week

Notable Policy Events –

  • Wednesday, February 20
    • Health Affairs, “Media Briefing with CMS: National Health Spending Projections Through 2027.”
    • Brookings Institution, “Emerging Policy Solutions to Surprise Medical Bills.” Additional information: https://brook.gs/2Szxv07
    • National Academy of Medicine, “Webinar: Procuring Interoperability: Achieving High-Quality, Connected, and Person-Centered Care.” Additional information: https://bit.ly/2STCf04

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

 FY 2019 Appropriations –

  • On February 15, the President signed H.J. Res. 31 into law, which provides appropriations to several government agencies through the remainder of Fiscal Year 2019, including U.S. Food & Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). Bill text: https://bit.ly/2DN4FiW

Legislative Activity –

  • On February 11, Senate Aging Committee Chair Collins (R-ME) and six bipartisan cosponsors introduced S. 433, which would aim to improve home health payment reforms under the Medicare program. Press release: https://bit.ly/2SWpAcH
  • On February 12, Rep. Lee (D-CA) introduced H.R. 1151, which would allow veterans to use, possess, or transport medical marijuana and to discuss the use of medical marijuana with a physician of the VA. Companion legislation was introduced by Sens. Schatz (D-HI) and Kaine (D-VA) in the Senate (S. 445). Press release: https://bit.ly/2Gts0tp
  • Also on February 12, Sens. Gardner (R-CO) and Peters (D-MI) introduced the Veterans Improved Access and Care Act (S. 450) which would require the VA Secretary to carry out a pilot program to expedite the onboarding process for new VA medical providers and reduce the duration of the hiring process. Press release: https://bit.ly/2UYCCnm
  • Also on February 12, Senate Finance Committee Ranking Member Wyden (D-OR) and Sens. Cramer (R-ND), Klobuchar (D-MN), and Hoeven (R-ND) introduced S. 454, which would direct the FCC to establish the Office of Rural Broadband. Press release: https://bit.ly/2SRWT0r
  • Also on February 12, Sens. Shaheen (D-NH), Peters (D-MI), Kaine (D-VA), and Hassan (D-NH) introduced the Marketing and Outreach Restoration to Empower (MORE) Health Education Act of 2019 (S. 455), which would ensure that the Administration fully funds outreach, marketing, and education efforts to promote health insurance coverage offered on the federal health insurance Marketplaces established by the ACA. Press release: https://bit.ly/2SEolzy Bill text: https://bit.ly/2N6c1ly
  • Also on February 13, Rep. Hartzler (R-MO) and six cosponsors introduced H.R. 1163, which would authorize the Veterans Health Administration (VHA) to begin the recruitment and hiring process for health care providers up to two years prior to the completion of their required training. The bill would also release physicians from non-compete agreements for the purpose of serving in the VHA. Press release: https://bit.ly/2Gtdemq
  • Also on February 13, Rep. Chu (D-CA) introduced the Acupuncture for Heroes and Seniors Act (H.R. 1182), which would ensure access to acupuncturist services through the VA. Press release: https://bit.ly/2V1CT9i
  • Also on February 13, Rep. Golden (D-ME) and five cosponsors introduced the Forcing Limits and Abusive and Tumultuous (FLAT) Prices Act (H.R. 1188), which would shorten monopoly periods for prescription drugs that are the subjects of sudden price hikes. Sen. Durbin (D-IL) introduced companion legislation in the Senate (S. 366). Press release: https://bit.ly/2UZITiM
  • Also on February 13, Rep. Grijalva (D-AZ) and 22 bipartisan cosponsors introduced the Native American Suicide Prevention Act (H.R. 1191), which would require collaboration among states and tribal nations in the design and implementation of statewide suicide intervention and prevention strategies. Sen. Warren (D-MA) and 16 bipartisan cosponsors introduced companion legislation in the Senate (S. 467) Press release: https://bit.ly/2X4Lx8U
  • Also on February 13, Sens. Warner (D-VA), Cardin (D-MD), Shaheen (D-NH), and Baldwin (D-WI) introduced the Protecting Americans with Pre-Existing Conditions Act (S. 466), which would provide that certain guidance related to 1332 waivers that promote plans that are non-compliant with the ACA shall have no force or effect. Companion legislation was introduced in the House by Reps. Kuster (D-NH), Beyer (D-VA), and Courtney (D-CT) (H.R. 986). Press release: https://bit.ly/2DLbrp6 Bill text: https://bit.ly/2BCUNYC
  • Also on February 13, Sen. Stabenow (D-MI) and 16 cosponsors introduced the Medicare at 50 Act (S. 470), which would give individuals between the ages of 50 and 64 years old the option of buying into Medicare. Companion legislation was introduced in the House by Reps. Higgins (D-NY), Larson (D-CT), Courtney (D-CT), and Welch (D-VT). Press release: https://bit.ly/2X3lVsV
  • Also on February 13, Senate Finance Committee Ranking Member Wyden (D-OR) and eight Democratic cosponsors introduced S. 474, which would require drug manufacturers to publicly justify unnecessary price increases. Ranking Member Wyden (D-OR) also introduced S. 475 with five cosponsors, which would prevent catastrophic out-of-pocket spending on prescription drugs for seniors and individuals with disabilities, and S. 476 with three cosponsors, which would provide greater transparency of discounts provided by drug manufacturers.
  • On February 14, Rep. Cartwright (D-PA) and 20 cosponsors introduced The Climate Change Health Protection and Promotion Act (H.R. 1243), which would direct the HHS Secretary to develop a national strategic plan and program to assist health professionals and systems in preparing for and responding to the public health effects of climate change. Sens. Markey (D-MA), Schatz (D-HI), and Whitehouse (D-RI) introduced companion legislation in the Senate (S. 523). Press release: https://bit.ly/2S5wPdK
  • Also on February 14, Reps. Duffy (R-WI), Peterson (D-MN), and Gianforte (R-MT) introduced H.R. 1265, which would eliminate the mandatory Certified Nurse Assistant (CNA) training lockout for Skilled Nursing Facilities (SNF) and instead allow the HHS Secretary to impose a lockout based on a substandard quality of care. Press release: https://bit.ly/2TQM7oF
  • Also on February 14, Reps. Kaptur (D-OH), Ryan (D-OH), Rutherford (R-FL), and Kilmer (D-WA) introduced the Veterans’-Specific Education for Tomorrow’s Health Professionals Act of 2019 (H.R. 1271), which would create a three-year pilot program at a minimum of five VHA medical centers to give undergraduates enrolled in pre-health programs the opportunity to gain clinical observation experience. Press release: https://bit.ly/2SAujS2
  • Also on February 14, Rep. Lujan (D-NM) and 40 cosponsors introduced the State Public Option Act (H.R. 1277), which would allow states to create a Medicaid buy-in program for all residents regardless of income. Sen. Schatz (D-HI) and 22 cosponsors introduced companion legislation in the Senate (S. 489). Press release: https://bit.ly/2DFLIhT Bill text: https://bit.ly/2BF21vk
  • Also on February 14, Sen. Rounds (R-SD) introduced S. 498, which would provide for an independent outside audit of the Indian Health Service. Press release: https://bit.ly/2X2reJ2
  • Also on February 14, Senate Veterans’ Affairs Committee Ranking Member Tester (D-MT) and 26 bipartisan cosponsors introduced the Deborah Sampson Act (S. 514), which would expand group counseling for veterans, increase the number of days of maternity care VA facilities can provide, and authorize additional grants for organizations supporting low-income women veterans. Press release: https://bit.ly/2TQwzkL Bill text: https://bit.ly/2EemKb3
  • Also on February 14, Sen. Cantwell (D-WA) and 32 bipartisan cosponsors introduced the Lymphedema Treatment Act (S. 518), which would require Medicare Part B to cover physician-prescribed compression therapy garments for lymphedema. Press release: https://bit.ly/2TQJMdo    

Medicare –

  • On February 15, CMS proposed to cover CAR T-cell therapy, a new form of cancer therapy that uses a patient’s own immune system to fight the disease, under “Coverage with Evidence Development” (CED). Currently, there is no national Medicare policy for covering the therapy, so Medicare Administrative Contractors (MACs) have discretion over whether to pay for it. Comments are due by March 18. Press release: https://go.cms.gov/2SXbV52

 Medicaid –

  • On February 11, CMS released guidelines on the 2019 Federal Poverty Level Standards; the poverty guidelines for 2019 is $25,750 for a family of four, a 2.4 percent price increase between calendar years 2017 and 2018. Guidance: https://bit.ly/2tn5tWC
  • On February 12, HHS released a final evaluation of the Balancing Incentive Program (BIP), which offered states temporary enhanced federal financial participation for Medicaid home and community-based services (HCBS). Of the 18 states that participated in BIP, most met their HCBS spending and infrastructure implementation goals. Summary: https://bit.ly/2DF5eeq Report: https://bit.ly/2SZN5l4
  • On February 14, CMS released a notice of opportunity for an administrative hearing concerning the finding that the Texas Health and Human Services Commission (HHSC) is not properly calculating the post-eligibility treatment of income (PETI) for institutionalized individuals and certain participants in home and community-based services (HCBS) waivers. Requests to participate are due by March 18. Notice: https://bit.ly/2Xeo8Su

 Payment and Delivery System Reform –

  • On February 14, CMS launched the Emergency Triage, Treat, and Transport (ET3) model, which will make it possible for participating ambulance suppliers and providers to partners with qualified health care practitioners to deliver treatment in place (either in-person or through telehealth) and with alternative destination sites (such as primary care offices or urgent care clinics) to provide care for Medicare beneficiaries following a medical emergency fofr which they have accessed 911 services. CMS anticipates releasing a Request for Applications in Summer 2019 for Medicare-enrolled ambulance suppliers and providers. Press release: https://go.cms.gov/2SBk4Nw Fact sheet: https://go.cms.gov/2UYD1pZ Model website: https://bit.ly/2trlafq

 Drug and Medical Device Prices and Regulation –

  • On February 11, U.S. Food and Drug Administration (FDA) sent 12 warning letters and 5 advisory letters to companies whose products are being illegally marketed as unapproved new drugs because they claim to prevent, treat, or cure Alzheimer’s disease. Press release: https://bit.ly/2RUU9uW
  • On February 13, House Energy & Commerce Chair Pallone (D-NJ), Ranking Member Walden (R-OR), Health Subcommittee Chair Eshoo (D-CA), Health Subcommittee Ranking Member Burgess (R-TX), Oversight Subcommittee Chair DeGette (D-CO), and Oversight Subcommittee Ranking Member Guthrie (R-KY) penned a letter to FDA Commissioner Gottlieb requesting a briefing on contaminated drugs and the agency’s foreign drug inspections. Press release: https://bit.ly/2Iqed8K Letter: https://bit.ly/2UUBt0b
  • On February 14, FDA authorized the first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices. Press release: https://bit.ly/2DHoibT
  • On February 15, FDA announced a new pathway for Competitive Generic Drug Therapies (CGTs), which will allow companies to submit requests to designate a drug as a CGT at the time of submitting an abbreviated new drug application (ANDA) or at any time before the original ANDA submission. Press release: https://bit.ly/2IgpGrJ

 Veterans and Military Health –

  • On February 11, Department of Veterans Affairs (VA) announced plans to released new capabilities this summer providing veterans who receive care at the VA with the ability to access their personal medical data using the Health Records on iPhone feature from Apple. Press release: https://bit.ly/2IefNLa
  • On February 13, VA announced it is inviting training providers to participate in the Veteran Employment Through Technology Education Courses (VET TEC) pilot program to prepare veterans for careers in the high-tech workforce. Press release: https://bit.ly/2TTEFJm
  • On February 14, VA announced it will discontinue the Rapid Appeals Modernization Program (RAMP), which provided eligible veterans with early resolutions to their appealed claims. The program will be related by the implementation of the Veterans Appeals Improvement and Modernization Act of 2017 which takes effect on February 19. Press release: https://bit.ly/2IjsPH8

 Health Data and IT –

  • On February 11, CMS released a proposed rule on interoperability and patient access, which is intended to make patient data more useful and transferable through open, secure, standardized, and machine-readable burdens on healthcare providers. Comments will be due in mid-April. Fact sheet: https://go.cms.gov/2E3dp5v Proposed rule: https://go.cms.gov/2GvrgnI
  • Also on February 11, HHS Office of Civil Rights (OCR) proposed a new rule to support seamless and secure access and exchange of electronic health information through standardized application programming interfaces (APIs). Comments will be due in mid-April. Press release: https://bit.ly/2TJyRSG Blog: https://bit.ly/2Ec6kjc Proposed rule: https://bit.ly/2URNKTe
  • On February 12, CMS Administrator Verma delivered remarks at the 2019 HIMSS Conference, highlighting the agency’s MyHealthEData initiative and the recently released interoperability proposed rule. Transcript: https://go.cms.gov/2N4nP85

 Substance Use and Mental Health –

  • On February 11, FDA and Centers for Disease Control and Prevention (CDC) released additional data from the joint FDA/CDC 2018 National Youth Tobacco Survey, which showed that approximately 4.9 million middle and high school students were current users of some type of tobacco product in 2018, up from 3.6 million in 2017. Press release: https://bit.ly/2MZ2PiU
  • Also on February 11, House Republican Energy & Commerce Committee leaders penned a letter to Democratic Energy & Commerce leaders asking for hearings to review the implementation of the SUPPORT for Patients and Communities Act and discuss additional efforts to address the ongoing opioid crisis. Press release: https://bit.ly/2IczRx9 Letter: https://bit.ly/2X2IEVT
  • On February 12, HHS released a report on the use of medication-assisted treatment (MAT) for opioid use disorder in employer-sponsored health insurance at two timepoints, 2006-2007 and 2014-2015. The study found that MAT use was similar in the two periods, with buprenorphine being the most common. Summary: https://bit.ly/2N6ACqo Report: https://bit.ly/2V3daNQ Difference in Out-of-Pocket Costs: https://bit.ly/2DJWhjT
  • Also on February 12, FDA issued its first warning letter under the Drug Supply Chain Security Act to McKesson Corp. for potential violations. Press release: https://bit.ly/2DuNaDQ
  • Also on February 12, Substance Abuse and Mental Health Administration (SAMHSA) issued a Treatment Improvement Protocol (TIP) to improve access to treatment by American Indians and Alaska Natives for substance use disorders. Press release: https://bit.ly/2DzNFMY
  • Also on February 12, U.S. Preventive Services Task Force (USPSTF) issued a final recommendation statement on interventions to prevent perinatal depression. The Task Force recommends that clinicians provide or refer pregnant or postpartum persons who are at increased risk for perinatal depression to counseling interventions. Recommendation: https://bit.ly/2GNEKKK
  • Also on February 12, House Energy & Commerce Oversight Subcommittee Chair DeGette (D-CO) and Sen. Markey (D-MA) penned a letter to FDA Commissioner Gottlieb to provide documents related to its approval of Dsuvia, a new formulation of the opioid painkiller sufentanil. Press release: https://bit.ly/2DGFP45 Letter: https://bit.ly/2GsDWf6
  • On February 13, Sen. Markey (D-MA) sent a letter to U.S. Surgeon General Adams calling attention to recent guidance issued by the Massachusetts Division of Insurance, which addresses how life insurance companies should approach prescriptions for naloxone in underwriting analyses. Press release: https://bit.ly/2GvPb6y Letter: https://bit.ly/2X4y40F
  • Also on February 13, National Institutes of Health (NIH) released a report showing that the number of U.S. adults age 18 and older suffering from at least one painful health condition increased substantially from 120.2 million in 1997/98 to 178 million in 2013/14. The use of strong opioids also increased by over 6 million individuals. Press release: https://bit.ly/2tmEACw
  • On February 14, Sens. Durbin (D-IL), Reed (D-RI), Whitehouse (D-RI), Blumenthal (D-CT), and Brown (D-OH) penned letters to Walgreens, Walmart, and Rite Aid urging them to stop selling tobacco products. Press release with links to letters: https://bit.ly/2tmliNt
  • Also on February 14, Rep. Trone (D-MD) announced the formation of the Freshman Working Group on Addiction, a 36-member, bipartisan group focused on promoting policies to end the addiction crisis in the U.S. Press release: https://bit.ly/2UYM6iz
  • On February 15, HHS and U.S. Department of Agriculture (USDA) announced a partnership to create addiction recovery transitional housing in rural communities. Press release: https://bit.ly/2tswI21

 Misc. –

  • On February 13, HHS released a study finding that post-hospital MRSA infections reduced by 30 percent through use of antiseptic soap, mouthwash, and antibiotic nasal ointment. Press release: https://bit.ly/2DGzTYR
  • On February 14, HHS announced plans to release a funding opportunity for a new Rural Maternity and Obstetrics Management Strategies (RMOMS) Program. Press release: https://bit.ly/2tn6AFM
  • Also on February 14, HHS released a report on current collaborations between housing providers and health care providers. The issue brief highlights key issues from three current collaborations in Texas, Oregon, and New York. Summary: https://bit.ly/2BDGtPD  Report: https://bit.ly/2GHHk5c
  • Also on February 14, House Oversight Committee Chair Cummings (D-MD), Senate HELP Committee Ranking Member Murray (D-WA), and Sens. Hassan (D-NH) and Harris (D-CA) sent a letter to Office of Management and Budget (OMB) Director Mulvaney and Office of Information and Regulatory Affairs (OIRA) Administrator Rao noting their concerns about the regulatory review process of the Title X gag rule. Press release: https://bit.ly/2X7XvP9 Letter: https://bit.ly/2IjuBYO
  • Also on February 14, Treasury Department announced a Notice of Funding Availability for the Social Impact Partnership Demonstration Projects and feasibility studies to prepare for those projects. Press release: https://bit.ly/2Na1kOQ Notice: https://bit.ly/2N5an3T