What’s Ahead: This Week


Hearings and Markups –

  • Tuesday, December 17
    • Senate Judiciary Committee, “Tackling the Opioid Crisis: A Whole-of-Government Approach.”

Notable Policy Events – 

  • Monday, December 16
    • Alliance for Health Policy, “Perspectives on Health Policy.” Additional information: http://bit.ly/35futRg

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

Legislative Activity –

Committee Actions and Votes –

  • On December 10, the Senate passed by a 91-2 vote the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 (S. 2740), which would clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application. The bill now moves to the House for consideration. Press release: http://bit.ly/35cs89B Bill text: http://bit.ly/2JBoQ79
  • On December 11, the Senate unanimously passed the Support for Suicide Prevention Coordinators Act (H.R. 2333), which would direct the Comptroller General of the United States to conduct an assessment of the responsibilities, workload, and vacancy rates of Department of Veterans Affairs suicide prevention coordinators. Having previously passed the House, the bill now moves to the President for signature. Press release: http://bit.ly/2Pil4ml Bill text: http://bit.ly/35hFukN
  • Also on December 11, the Senate Commerce, Science, and Transportation Committee approved by voice vote the National Suicide Hotline Designation Act of 2019 (S. 2661), which would designate ‘9–8–8’ as the universal telephone number for the purpose of the national suicide prevention and mental health crisis hotline system operating through the National Suicide Prevention Lifeline and through the Veterans Crisis Line. The bill now moves to the full Senate for consideration. Press release: http://bit.ly/2taQ4Mh Bill text: http://bit.ly/35l0Y0a
  • On December 12, the House passed by a 230-192 vote the Elijah E. Cummings Lower Drug Costs Now Act (H.R. 3), which would establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees. The bill now moves to the Senate for consideration Press release: http://bit.ly/36xRhvM Senate Finance Committee Chair Grassley (R-IA) Statement: http://bit.ly/2YVfc5P Bill text: http://bit.ly/2RKgEX3
  • Also on December 12, the Senate passed by a 72-18 vote nomination of Dr. Stephen Hahn to serve as U.S. Food and Drug Administration (FDA) Commissioner. Press releases: http://bit.ly/2ssoPMN and http://bit.ly/2LRpmip
  • Also on December 12, the Senate HELP Committee passed by a voice vote the Title VII Reauthorization (S. 2997), which would revise and extend health workforce programs under title VII of the Public Health Service Act, and the Geriatrics Workforce Improvement Act (S. 299), which would reauthorize programs that support interprofessional geriatric education and training to develop a geriatric-capable workforce and improve health outcomes for a growing and diverse aging American population and their families. The bills now move to the full Senate for consideration. Press release: http://bit.ly/2Ee5txF

Introduced Legislation –

  • On December 9, Rep. Walden (R-OR) and 128 cosponsors introduced the Lowest Costs, More Cures Act of 2019 (H.R. 19), which would provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of such Act, the Food and Drug Administration. Press release: http://bit.ly/2t8dguN Bill text: http://bit.ly/2YF6qZx Section-by-section: http://bit.ly/36oDFmh
  • Also on December 9, Rep. Beatty (D-OH) and eight cosponsors introduced the End Price Gouging for Insulin Act (H.R. 5364), which would require the Secretary of Health and Human Services to establish an annual reference price for insulin products for purposes of Federal health programs. Press release: http://bit.ly/2RNTTl7
  • Also on December 9, Sens. Cassidy (R-LA), Jones (D-AL), Moran (R-KS) and Shaheen (D-NH) introduced the Primary Care Enhancement Act (S. 2999), which allow individuals with direct primary care service arrangements to remain eligible individuals for purposes of health savings accounts. Press release: http://bit.ly/2rF8pkn
  • Also on December 9, Sens. Cassidy (R-LA) and Hassan (D-NH) introduced S. 3000, which would allow PDP sponsors of prescription drug plans and Medicare Advantage organizations offering MA-PD plans to share with enrollees a portion of savings from switching to lower cost therapeutic alternative medications. Press release: http://bit.ly/2RGL8ck
  • Also on December 9, Sens. Toomey (R-PA) and Crapo (R-ID) introduced the Permanent Relief for Seniors and Medicare, Medicaid, Human Services Extension Act of 2019 (S. 3001), which would provide for certain extensions with respect to the Medicare and Medicaid programs under titles XVIII and XIX of the Social Security Act. Press release: http://bit.ly/38uKLaX Summary: http://bit.ly/2PdKPUA Bill text: http://bit.ly/2rsLSHw
  • On December 10, Sens. Murkowski (R-AK), Jones (D-AL), King (I-ME) and Gardner (R-CO) introduced the Effective Suicide Screening and Assessment in the Emergency Department Act of 2019 (S. 3006), which would establish a program to improve the identification, assessment, and treatment of patients in the emergency department who are at risk or suicide. Press release: http://bit.ly/2YLSe0T
  • Also on December 10, Sens. Toomey (R-PA) and Crapo (R-ID) introduced the Encouraging Innovative Benefit Design to Lower Costs for Seniors Act (S. 3013), which would allow for the offering of additional prescription drug plans under Medicare part D. Press release: http://bit.ly/2LRsfjf One-pager: http://bit.ly/2RPhpy8
  • On December 11, Sens. Baldwin (D-WI), Sullivan (R-AK), Tester (D-MT) and Daines (R-MT) introduced the Commitment to Veteran Support and Outreach (CVSO) Act (S. 3020), which would authorize the Secretary of Veterans Affairs to enter into contracts with States or to award grants to States to promote health and wellness, prevent suicide, and improve outreach to veterans. Press release: http://bit.ly/2ROiGW1 Summary: http://bit.ly/35tWFjv
  • On December 12, Rep. Harder (D-CA) introduced the Increasing Access to Mental Health Act (H.R. 5411), which would direct the Secretary of Health and Human Services to establish a Task Force on Local Mental Health Needs. Press release: http://bit.ly/2Phm9uE

Individual Market and ACA Implementation –

  • On December 10, CMS updated the direct enrollment web-broker program participation requirements to require prospective and existing web-brokers to submit privacy and security-related documentation demonstrating compliance with current requirements and responding to an annual data request. Prospective brokers will also be required to undergo a pre-approval website review. Update: https://go.cms.gov/2rzRW0Y
  • On December 11, CMS announced that 1,005,673 individuals selected plans on the federal health insurance exchange during the sixth week of this year’s open enrollment period, for a cumulative total of 3,882,671. December 15 is the final day of this year’s Healthcare.gov open enrollment period. Fact sheet: https://go.cms.gov/34lYCNb
  • Also on December 11, CMS released a fact sheet on average monthly effectuated enrollment and premium data for the individual market Federal and State-Based Exchanges for the first six months of the 2019 plan year, finding that effectuated enrollments as a percent of plan selections were 89% for 2019, up from 87% for the prior 2019 benefit year. Fact sheet: https://go.cms.gov/2LNNrqg
  • On December 12, Sens. Hirono (D-HI), Sullivan (R-AK) and Murkowski (R-AK) sent a letter to CMS Administrator Verma requesting CMS to extend deadline for 2020 Open Enrollment in the Federal Health Care Marketplace to 5:00 am EST on December 16 to accommodate residents of Hawaii and Alaska. Press release: http://bit.ly/2t7Ncjh Letter: http://bit.ly/2t8hNgC

Medicare –

  • On December 9, Rep. Blunt Rochester (D-DE) and seven House colleagues sent a letter to CMS Administrator Verma requesting information regarding the Medicare plan finder tool. Press release: http://bit.ly/2se9oYO Letter: http://bit.ly/2PyJ9nW
  • On December 10, House Energy & Commerce Chair Pallone (D-NJ), Ranking Member Walden (R-OR), House Ways & Means Committee Chair Neal (D-MA) and Ranking Member Brady (R-TX) sent a letter to CMS Administrator Verma regarding the Medicare Plan Finder tool, and urged CMS to open a special enrollment period for beneficiaries who used the plan finder to make enrollment decisions. Press release: http://bit.ly/2RHQl3v Press release: http://bit.ly/34bjdnp Letter: http://bit.ly/2RGYmpx
  • On December 11, Sen. Casey (D-PA) sent a letter to CMS Administrator Verma regarding recent steps taken by CMS to prevent older adults transitioning from the Marketplace to Medicare coverage from experiencing enrollment penalties or gaps in coverage. Press release: http://bit.ly/2EcK1ZR Letter: http://bit.ly/2LTydQB
  • On December 12, HHS OIG released a report finding that Medicare Advantage Organizations (MAO) commonly use chart reviews as a tool to add diagnoses for the purposes of MA risk adjustment; OIG found that diagnoses reported on chart reviews and not on any service records resulted in an estimated $6.7 billion in risk-adjusted payments to MAOs for 2017. Summary with link to report: http://bit.ly/34huORW

Medicaid –

  • On December 12, CMS approved South Carolina’s Healthy Connections Works Waiver which requires certain beneficiaries to maintain work and community engagement as a condition of Medicaid eligibility; non-exempt beneficiaries must complete a minimum of 80 hours monthly of community engagement activities. Waiver: http://bit.ly/2slINce

New Payment and Delivery System Models –

  • On December 9, CMS posted the Payer Solicitation Addendum for the Primary Care First Model Options. More information: http://bit.ly/2Pu5tkf

Prescription Drug and Medical Device Policy –

  • On December 9, Sens. Warren (D-MA), Cotton (R-AR), Romney (R-UT) and Kaine (D-VA) sent a letter to Secretary of Defense Esper about the national security and public health risks posed by China’s influence over the drug supply chain. Press release: http://bit.ly/2RB2S99 Letter: http://bit.ly/2P3O1lU
  • On December 10, U.S. Government Accountability Office (GAO) released a report finding persistent challenges with FDA foreign inspections and concerns about FDA’s ability to oversee the global drug supply chain. Summary with link to report: http://bit.ly/38voNo0
  • On December 11, FDA posted a warning letter to Alkermes, Inc. for misbranding Vivitrol by omitting warnings about the most serious risks in advertisement for the medication-assisted treatment drug. Press release: http://bit.ly/2Pymubj Letter: http://bit.ly/2qHz7Z3
  • On December 12, Sen. Stabenow (D-MI) led ten senators and House Oversight & Reform Committee Chair Maloney (D-NY) in a letter to U.S. Patent and Trademark Office Director Iancu calling for a review of allegations against Gilead related to their patent on HIV prevention medication. Press release: http://bit.ly/2PhbDDu Letter: http://bit.ly/2tfww9L

Health Data and IT –

  • On December 12, HHS Office for Civil Rights (OCR) announced a second enforcement action and settlement under its HIPAA Right of Access Initiative, which promises to vigorously enforce the rights of patients to get access to their medical records promptly, without being overcharged, and in the readily producible format of their choice. Press release: http://bit.ly/34fmqTa Resolution agreement: http://bit.ly/35kFJvs
  • Also on December 12, HHS Office of the National Coordinator for Health IT (ONC) posted a blog on ONC’s efforts to advance interoperable social determinants of health data, highlighting that since the release of ONC’s 2015 Certification Edition, 72 health IT developers have voluntarily certified 93 unique products to an SDOH-oriented certification criterion. Blog post: http://bit.ly/2LOA7ll
  • On December 13, House Oversight & Reform Committee, National Security Subcommittee Chair Lynch (D-MA) sent letters to Google and Apple seeking information related to foreign entities accessing U.S. mobile application data. Press release: http://bit.ly/38zEfzB Letter: http://bit.ly/38ECe5o Letter: http://bit.ly/34jUH3J

Mental Health and Substance Use Policy –

  • On December 12, GAO released a report finding that state and federal oversight of compliance for coverage of mental health and substance use disorder varies and recommended the Departments of Labor and HHS evaluate the effectiveness of their oversight approaches and whether relying on targeted oversight is effective for ensuring compliance with mental health and substance use parity requirements. Summary with link to report: http://bit.ly/2sn1EUg
  • Also on December 12, the Agency for Healthcare Research and Quality (AHRQ) released a report finding that certain features of prescription drug monitoring programs decreased the growth of emergency department visits and inpatient hospitalizations for opioid-related diagnosis between 2005-2013. Report: http://bit.ly/35kC014
  • Also on December 12, the White House office of National Drug Control Policy (ONDCP) announced the grand prize winner and runner-up for the Opioid Detection Challenge, a $1.55 million global prize competition for rapid, nonintrusive detection tools that will help find illicit opioids in international mail. Press release: http://bit.ly/2RQE0dE

Veterans and Military Health –

  • On December 9, VA announced that the agency registered more than 5 million users on their web-based patient tool My HealtheVet, which enables Veterans to proactively engage with their health care team and make informed decisions about their health and well-being. Press release: http://bit.ly/2E3gq54
  • Also on December 9, VA announced that disability claims backlog reached its lowest point ever on November 23, evidence that VA’s modernization efforts are yielding positive results. Press release: http://bit.ly/36huUKJ
  • Also on December 9, VA announced plans to move toward nationwide availability of virtual hearings for Veterans in 2020. The virtual hearings are based on the Veterans Health Administration’s telehealth platform and lets Veterans participate in their appeals hearings from their homes. Press release: http://bit.ly/2LDxmUe
  • On December 10, VA Office of Inspector General (OIG) released a report finding that 17 percent of routine exams and 25 percent of urgent exams were not complete within the required time frames due to staff and equipment shortages, issues with staff allocation and insufficient monitoring of the scheduling process. Summary with link to report: http://bit.ly/2YBpHuP
  • Also on December 10, VA was recognized for health IT innovations that directly impact Veterans, through developments in digital and cloud-based solutions and health-IT modernization initiatives. Press release: http://bit.ly/2Pw1jqg
  • Also on December 10, VA and Walmart opened a telehealth location to serve Veterans in rural areas. Press release: http://bit.ly/2YEzcsZ
  • On December 11, VA OIG released a report evaluating a Veterans’ Integrated Service Network medical facility, finding that the facility’s patient safety manager did not monitor progress toward root cause analysis action item completion and made four additional recommendations for standards for screening, operations, and tracking. Summary with link to report: http://bit.ly/2EbdC6d
  • Also on December 11, VA announced key changes to increase transparency and ensure Veterans have the best information regarding the performance of VA health care facilities, including discontinuing its star-rating system, which will make it easier for Veterans to compare VA facilities and non-VA facilities. Press release: http://bit.ly/34k7XVO
  • Also on December 11, GAO released a report highlighting opportunities for VA to identify and address racial and ethnic disparities and recommended that VA include measures of progress and clear lines of accountability. Racial and ethnic minority veterans made up roughly 22 percent of the total veteran population in 2016. Summary with link to report: http://bit.ly/2tdp6Ul

Public Health –

  • On December 9, HHS announced a six-year, $226 million contract to increase capacity to produce recombinant influenza vaccine in the United States. Press release: http://bit.ly/2P4gSGt
  • On December 10, AHRQ issued a request for information and data submissions to inform review on the maternal and fetal effects of mental health treatments in pregnant and breastfeeding women. Submissions are due by January 15. RFI: http://bit.ly/2POJZx0
  • On December 13, HHS issued a notice for the opportunity to co-sponsor Office of Disease Prevention and Health Promotion Healthy Aging Summit and Regional Workshops. Submissions are due by January 17. Notice: http://bit.ly/34n1mtH

Misc.  –

  • On December 9, Sens. McSally (R-AZ), Sinema (D-AZ), Collins (R-ME) and Cantwell (D-WA) sent a letter to Senate Majority Leader McConnell (R-KY), Minority Leader Schumer (D-NY), Senate Finance Committee Chair Grassley (R-IA) and Ranking Member Wyden (D-OR) urging them to extend the medical expense deduction in an end-of-year funding package. Press release: http://bit.ly/2E6yMSR Letter: http://bit.ly/2YFHgJW
  • On December 11, House Ways & Means Committee Chair Neal (D-MA) and Ranking Member Brady (R-TX) announced an agreement on a strategy for the Committee to pursue on surprise medical billing. Press release: http://bit.ly/2PMwe1w Agreement: http://bit.ly/2EdqKaG
  • Also on December 11, Reps. Kennedy (D-MA), Cardenas (D-CA), Jayapal (D-WA), Schakowsky (D-IL) and Rush (D-IL) sent a letter to President Trump urging him to remove CMS Administrator Verma. Press release: http://bit.ly/36xkw1B Letter: http://bit.ly/2rxOVhD
  • On December 13, HHS announced a funding opportunity for health services research projects that improve the quality of care and patient outcomes during transitions of care. Applications are due by February 5. Announcement: http://bit.ly/36AZdfF
  • Also on December 13, HHS issued a request for supplemental evidence and data submissions to inform a review on “Management of High-Need, High-Cost Patients: A Realist and Systematic Review.” Submissions are due by January 16. Request: http://bit.ly/2EnKclf