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


 What’s Ahead: This Week

 Hearings and Markups –

  • Tuesday, April 2
    • House Education & Labor Committee, Subcommittee on Health, Employment, Labor and Pensions, “Examining Surprise Billing: Protecting Patients from Financial Pain.”
    • House Energy & Commerce Committee, Subcommittee on Oversight & Investigations, “Priced Out of a Lifesaving Drug: The Human Impact of Rising Insulin Costs.”
    • House Rules Committee, “Business Meeting: Condemning the Trump Administration’s Legal Campaign to Take Away Americans’ Health Care.”
    • House Appropriations Committee, Subcommittee on Labor-HHS-Education, “NIH Budget Request for FY 2020.”
    • House Veterans’ Affairs Committee, “MISSION Critical: Assessing the Technology to Support Community Care.”
  • Wednesday, April 3
    • House Appropriations Committee, Subcommittee on Agriculture-Rural Development-FDA, “FDA Budget Request for FY 2020.”
    • House Appropriations Committee, Subcommittee on Defense, “Defense Health Programs.”
    • Senate Appropriations Committee, Subcommittee on Defense, “Proposed Budget Estimates and Justification for FY 2020 for the Defense Health Program.”
  • Thursday, April 4
    • Senate Appropriations Committee, Subcommittee on Labor-HHS-Education, “Proposed Budget Estimates and Justification for FY 2020 for the Health and Human Services Department.”

 Notable Policy Events –

  • Monday, April 1
    • Cato Institute, “How Much Should Medicare Pay for Drugs?” Additional information: https://bit.ly/2TU3VDc
  • Tuesday, April 2
  • Thursday, April 4 – Friday, April 5
    • Medicare Payment Advisory Committee (MedPAC), “April Public Meeting.” Additional information: http://bit.ly/2U9b17c

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

 Legislative Activity –

  • On March 25, the House passed by voice vote the Medicaid Services Investment and Accountability Act of 2019 (H.R. 1839), which would extend protection for Medicaid recipients of home and community-based services against spousal impoverishment, establish a state Medicaid option to provide coordinated care to children with complex medical conditions through health homes, and prevent the misclassification of drugs for purposes of the Medicaid drug rebate program. Bill text: https://bit.ly/2U76Skh
  • Also on March 25, Reps. Kuster (D-NH) and Mullin (R-OK) introduced the Analyzing and Leveraging Existing Rx Transactions (ALERT) Act (H.R. 1845), which would direct the HHS Secretary to require that products they deem to be at risk for misuse, abuse, addiction, overdose, or drug interactions be dispensed using a prescription safety alert system. Press release: https://bit.ly/2WwwmnI
  • On March 26, Rep. Tonko (D-NY) and 5 bipartisan cosponsors introduced the Improving HOPE for Alzheimer’s Act (H.R. 1873), which would require the Department of Health and Human Services (HHS) to inform health care providers about Alzheimer’s care planning benefits through Medicare. Sen. Stabenow (D-MI) and 4 bipartisan cosponsors introduced companion legislation in the Senate (S. 880). Press release: https://bit.ly/2U0AiR1
  • Also on March 26, Reps. Kennedy (D-MA) and Katko (R-NY) introduced the Stabilize Medicaid and CHIP Coverage Act (H.R. 1879), which would provide for 12-month continuous enrollment of individuals under the Medicaid and CHIP programs. Sens. Brown (D-OH), Baldwin (D-WI), Warren (D-MA), and Whitehouse (D-RI) introduced companion legislation in the Senate (S. 873). Press release: https://bit.ly/2JMAlLw Bill text: https://bit.ly/2I23Qqd
  • Also on March 26, House Energy & Commerce Committee Chair Pallone (D-NJ) and 102 cosponsors introduced the Protecting Pre-Existing Conditions & Making Health Care More Affordable Act (H.R. 1884), which would strengthen pre-existing condition protections, undo the Trump Administration’s efforts to undermine the ACA, and limit the proliferation of non-ACA-compliant health plans. Press release: https://bit.ly/2OuFCGc Section-by-section summary: https://bit.ly/2FHlxJR Bill text: https://bit.ly/2UbxIXn
  • Also on March 26, the House Energy & Commerce Health Subcommittee favorably reported a package of 12 bills aimed at lowering health care and prescription drug costs. The legislation now moves to the full Committee for consideration. List of bills: https://bit.ly/2CHLIye
  • On March 27, Rep. Kelly (D-IL) and 23 Democratic cosponsors introduced the Mothers and Offspring Mortality and Morbidity Awareness (MOMMAs) Act (H.R. 1897), which would expand Medicaid coverage to new mothers’ entire 1-year postpartum period, establish a national obstetric emergency protocol through a federal expert committee, and standardize data collection and reporting pertaining to maternal and infant mortality. Companion legislation was introduced by Sens. Durbin (D-IL) and Duckworth (D-IL) in the Senate (S. 916). Press release: https://bit.ly/2U3MNv2
  • Also on March 27, Reps. Olson (R-TX), Schakowsky (D-IL), Kelly (D-IL), Doyle (D-PA), and Foster (D-IL) introduced the Preserving Rehabilitation Innovation Centers Act (H.R. 1901), which would preserve access to rehabilitation innovation centers under the Medicare program. Sens. Cassidy (R-LA) and Durbin (D-IL) introduced companion legislation in the Senate (S. 923). Press release: https://bit.ly/2TGSGZQ
  • Also on March 27, Reps. Kind (D-WI), Meng (D-NY), Walorski (R-IN), and LaHood (R-IL) introduced the Restoring Access to Medication Act (H.R. 1922), which would allow individuals to use health savings accounts (HSAs) and flexible spending accounts (FSAs) to pay for over-the-counter drugs. Press release: https://bit.ly/2uwnPoP Bill text: https://bit.ly/2HWnTpS
  • Also on March 27, Rep. Turner (R-OH) introduced the Health Coverage Tax Credit Reauthorization Act (H.R. 1939), which would allow eligible individuals to remain within the Health Coverage Tax Credit (HCTC) program past the program’s December 31, 2019 termination data, or upon leaving the program. Press release: https://bit.ly/2V04acA Bill text: https://bit.ly/2CKy79i
  • Also on March 27, Sens. Thune (R-SD) and Stabenow (D-MI) introduced the Rural Hospital Regulatory Relief Act (S. 895), which would permanently prohibit CMS from enforcing its direct supervision policy for certain outpatient therapeutic services. Press release: https://bit.ly/2FIHit0 Bill text: https://bit.ly/2TFFzYT
  • Also on March 27, Senate Aging Committee Chair Collins (R-ME) and Ranking Member Casey (D-PA) along with Sens. Capito (R-WV) and Jones (D-AL) introduced the Younger-Onset Alzheimer’s Disease Act, which would ensure the availability of programs and services for those with Alzheimer’s by allowing patients younger than age 60 to access them. Companion legislation was introduced in the House by by Reps. Rice (D-NY) and King (R-NY) (H.R. 1903). Press release: https://bit.ly/2HTmv7v
  • On March 28, Rep. Clyburn (D-SC) and 64 Democratic cosponsors introduced the Community Health Center and Primary Care Workforce Expansion Act of 2019 (H.R. 1943), which would expand and extend funding for federally qualified health centers and the National Health Service Corps. Sen. Sanders (I-VT) plans to introduce companion legislation in the Senate. Press release: https://bit.ly/2JOH7QE Summary: http://bit.ly/2V3WINJ Bill text: http://bit.ly/2V7kfgK
  • Also on March 28, Rep. Lieu (D-CA) and six bipartisan cosponsors introduced the Fighting Homelessness through Services and Housing Act (H.R. 1978), which would authorize a $750 million annual grant program for 5 years within the Health Resources and Services Administration for housing programs that offer comprehensive services and intensive case management for homeless individuals and families. Sens. Feinstein (D-CA) and Murkowski (R-AK) introduced companion legislation in the Senate (S. 923). Press release: https://bit.ly/2HYNa2Q
  • Also on March 28, Rep. S. Maloney (D-NY) and 63 cosponsors introduced the Prohibition of Medicaid Funding for Conversion Therapy Act (H.R. 1981), which would prohibit payments under the Medicaid program for sexual orientation conversion therapy. Press release: https://bit.ly/2FIDZlg
  • Also on March 28, Reps. O’Halleran (D-AZ) and Stefanik (R-NY) introduced the Community Health Investment, Modernization, and Excellence (CHIME) Act (H.R. 1983), which would extend the Community Health Centers Fund for 5 years. Press release: https://bit.ly/2CH6Ft4
  • Also on March 28, Sens. Klobuchar (D-MN), Collins (R-ME), and Rosen (D-NV) introduced S. 948, which would provide incentives for physicians to practice in rural and medically underserved communities. Press release: http://bit.ly/2V5hE6S
  • Also on March 28, Senate Aging Committee Chair Collins (R-ME) and Sens. Stabenow (D-MI), Markey (D-MA), Capito (R-WV), and Menendez (D-NJ) introduced the Health, Outcomes, Planning, and Education (HOPE) for Alzheimer’s Act (S. 901), which would require HHS to conduct outreach to make more health care providers aware of Medicare’s new Alzheimer’s care plans and report back on rates of utilization and barriers to access. Press release: https://bit.ly/2FK4y9Z

ACA and Individual Market –

  • On March 25, CMS released the Health Insurance Exchanges 2019 Open Enrollment Report, which showed that 11.4 million consumers selected or were automatically re-enrolled in an Exchange plan during Open Enrollment 2019, down from 11.8 million in 2018. Press release: https://go.cms.gov/2UVQm2H Fact sheet: https://go.cms.gov/2FywcX9
  • Also on March 25, CMS released guidance extending its non-enforcement policy for certain non-grandfathered health insurance coverage in the individual and small group markets. Guidance: https://go.cms.gov/2JIg4qd
  • On March 27, Rep. Blunt Rochester (D-AL) led a group of Energy & Commerce Committee democrats in a letter to HHS Secretary Azar and CMS Administrator Verma requesting that HHS and CMS make public any and all documents regarding the effectiveness of marketing and outreach efforts for the ACA. Press release: http://bit.ly/2CH1aL5 Letter: http://bit.ly/2CO9OHB
  • On March 28, U.S. District Judge Bates struck down the Trump Administration’s proposal to allow the formation of non-ACA compliant association health plans. Opinion: https://bit.ly/2TIVGVz
  • On April 1, Sen. Collins (R-ME) sent a letter to Attorney General Barr urging him to reconsider the Department of Justice’s decision not to defend the ACA. Press release: http://bit.ly/2VfIvxj Letter: http://bit.ly/2VfIOrX

 Medicare –

  • On March 26, CMS proposed to update its national coverage policy for Transcatheter Aortic Valve Replacement (TAVR), which would modernize the requirements that providers must meet to perform the procedure under Coverage with Evidence Development (CED). Press release: https://go.cms.gov/2U3bJ5R Proposed policy: https://go.cms.gov/2UfJtfp
  • Also on March 26, CMS Administrator Verma penned a letter to Senate Finance Committee Chair Grassley (R-IA) in response to Chairman Grassley’s inquiry regarding changes to Medicare payment rates for lab tests paid under the Clinical Laboratory Fee Schedule (CLFS). Her letter noted that CMS is continuing to work to ensure correct reporting and payment of lab tests under the CLFS. Press release: https://bit.ly/2TF008C Letter: https://bit.ly/2uzLV1U
  • On March 27, U.S. Government Accountability Office (GAO) released a report showing an estimated $27.5 billion in payment errors to CMS due to insufficient documentation in FY 2017. GAO recommended that CMS assess documentation requirements to identify improper payments. Summary with link to report: https://bit.ly/2CENosg
  • Also on March 27, CMS Administrator Verma penned an op-ed in the Wall Street Journal arguing against Medicare-for-all. Op-ed: https://on.wsj.com/2U5vkSV
  • On March 28, CMS rolled out new Part D policies to address the opioid epidemic, such as improved safety alerts at the pharmacy and drug management programs. Prescriber’s guide: https://go.cms.gov/2DOQz1G CMS blog: https://go.cms.gov/2Wpmufi

Medicaid –

  • On March 25, HHS Office of Inspector General (OIG) released its FY 2018 Medicaid Fraud Control Units (MFCU) annual report, which showed that MFCUs recovered $859 million in FY 2018. Summary with link to report: https://bit.ly/2JLr1r3
  • On March 27, Kentucky District Judge Boasberg struck down the proposal of work requirements as a condition of Medicaid eligibility in Kentucky and Arkansas, again deeming CMS’ reapproval of the Kentucky program “arbitrary and capricious” and stating that the Arkansas program “cannot stand.” Kentucky decision: https://bit.ly/2FySxTy Arkansas decision: https://wapo.st/2Ul35ik
  • On March 28, CMS released a final rule and interim final rule with comment that revises the rebate calculation for line extension drugs under the Medicaid covered outpatient drug program. Comments are due by May 31. Final rule and interim final rule: http://bit.ly/2U8sOvj
  • On March 29, CMS released proposed funding methodology for program years 2019 and 2020 for the Basic Health Program. Comments are due by May 3. Methodology: http://bit.ly/2CMkhmR
  • Also on March 29, CMS announced the approval of Utah’s request to expand its Medicaid program to 100 percent of the federal poverty level, the first time CMS has approved a partial expansion. The approval also includes an approved waiver to implement work requirements for certain beneficiaries. Approval: http://bit.ly/2iu4RJb

 Payment and Delivery System Reform –

  • On March 27, CMS announced the Artificial Intelligence Health Outcomes Challenge, a three-stage competition in partnership with the American Academy of Family Physicians (AAFP) and the Laura and John Arnold Foundation to accelerate AI solutions to better predict health outcomes such as unplanned hospital and SNF admissions for use by the Center for Medicare & Medicaid Innovation (CMMI) in testing payment and delivery models under section 1115 of the Social Security Act. Fact sheet: https://go.cms.gov/2TBcn5q Challenge website: https://bit.ly/2zuurab

 Drug and Medical Device Prices and Regulation –

  • On March 27, Senate Finance Committee Chair Grassley (R-IA) and Ranking Member Wyden (D-OR) penned a letter to HHS Inspector General Levinson regarding recent investigations into potential illegal kickback schemes by some pharmaceutical companies to exploit charitable organizations by giving them money to pay the copays of Medicare patients while encouraging the use of the companies’ own drugs. Press release: https://bit.ly/2uuNm1P Letter: https://bit.ly/2JABIN8
  • On March 29, FDA Commissioner Gottlieb released a statement on the FDA’s future efforts with respect to Expanded Access. Statement: http://bit.ly/2U8tktf

 Substance Use and Mental Health –

  • On March 26, HHS released a statistical brief on inpatients stays involving mental and substance use disorders (MSUD) in 2016. The study found that in 2016, there were nearly 10 million stays with a principal or secondary MSUD diagnosis, constituting more than 1 in 4 inpatient stays. Statistical brief: https://bit.ly/2U6N14s
  • Also on March 26, Oklahoma Attorney General Hunter announced a $270 million settlement with Purdue Pharma relating to their role in the opioid crisis. Press release: https://bit.ly/2JIgT2u
  • On March 27, Sens. Hassan (D-NH) and Markey (D-MA) penned a letter to FDA Commissioner Gottlieb calling for a fuller accounting of FDA’s past decision-making processes for the approval and labeling of opioid drugs. Press release: https://bit.ly/2OCnCtC Letter: https://bit.ly/2Ysps4C
  • On March 28, FDA issued a proposed rule that would establish requirements for the content and format of reports manufacturers must send to FDA to demonstrate substantial equivalence of a new tobacco product. Press release: https://bit.ly/2Oypvrg Proposed rule: https://bit.ly/2FHLI2Y

 Veterans and Military Health –

  • On March 25, Department of Veterans Affairs (VA) announced a partnership with the National Multiple Sclerosis Society to advance and improve lives of veterans living with MS. Press release: https://bit.ly/2HLIdeu
  • Also on March 25, Senate Veterans’ Affairs Committee Ranking Member Tester (D-MT) and House Veterans’ Affairs Committee Chair Takano (D-CA) led 55 Democratic members of Congress in a letter to VA Office of Regulation Policy and Management Director Shores voicing their concerns about the VA’s proposed Community Care access standards. Press release: https://bit.ly/2YwGnmQ Letter: https://bit.ly/2TG5Pm5
  • Also on March 25, VA announced a partnership with Objective Zero Foundation to aid in connecting veterans with suicide prevention support and resources. Press release: https://bit.ly/2OwzXQ3
  • On March 26, VA announced the availability of up to $15 million in grants for community organizations that provide adaptive sports and therapeutic recreational opportunities for disabled veterans and servicemembers. Press release: https://bit.ly/2WnoXai
  • Also on March 26, VA released a study finding that rising VA employee engagement has been the key to increased success at nearly 150 medical centers. Press release: https://bit.ly/2HLe136

 Health Data and IT –

  • On March 26, Office of the National Coordinator for Health IT (ONC) released a summary of public comment on the draft Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs. Comments: http://bit.ly/2U7HmLx
  • On March 27, HHS announced the Bringing Predictive Analytics to Healthcare Challenge, which is a new challenge competition to explore how predictive analytics may be applied to existing databases to forecast future trends in healthcare utilization and spending. Press release: https://bit.ly/2TYVgiW
  • Also on March 27, Senate Finance Committee Ranking Member Wyden (D-OR) released a summary of a proposal to improve out-of-pocket health care data cost transparency. Summary: https://bit.ly/2FJBJdB

 Misc. –

  • On March 25, HHS OIG released a report showing that vulnerabilities continue to exist in the HHS Small Business Innovation Research Program. Report: https://bit.ly/2U2mkho
  • Also on March 25, HHS announced a Notice of Funding Opportunity (NOFO) for a new Rural Maternity and Obstetrics Management Strategies program. Press release: http://bit.ly/2U6BNNn
  • On March 29, House Energy & Commerce Committee Chair Pallone (D-NJ) issued a statement on and sent a letter to the HHS OIG requesting that the OIG launch an investigation into reports that CMS Administrator Verma directed millions of dollars in federal contracts to political communications consultants. Press release: https://bit.ly/2uArDpb Letter: http://bit.ly/2VhpsCo
  • Also on March 29, HHS announced two new funding opportunity announcements seeking research proposals related to diagnostic safety and social determinants. Applications are due by May 29. Press release: http://bit.ly/2U6e28n