What’s Ahead: This Week

Hearings –

  • Tuesday, October 17
    • Senate HELP Committee, “The Cost of Prescription Drugs: How the Drug Delivery Systems Affects What Patients Pay, Part II.”
  • Thursday, October 19
    • Senate HELP Committee, “Examining How Healthy Choices Can Improve Health Outcomes and Reduce Costs.”

 Notable Policy Events –

  • Monday, October 16
    • National Committee for Quality Assurance, “Quality Talks.” Additional information: http://bit.ly/2xBuEof
  • Wednesday, October 18
    • S. Chamber of Commerce, “A Path Forward on Health Reform: Advancing Priorities and Innovative Solutions Amid Uncertainty.” Additional information: http://uscham.com/2xHv906
    • Washington Post, “Addiction in America: A Nation Responds.” Additional information: http://wapo.st/2xHQNRR
    • Axios Events, “Health Care: What’s Next?” Additional information: http://bit.ly/2ygF9kw
    • Medicaid Health Plans of America, “How Medicaid Plans Are Using AI to Improve Care.” Additional information: http://bit.ly/2xAUeKa


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

Administration –

  • On October 10, the White House announced that Eric Hargan will serve as the Acting Secretary of HHS, replacing Don Wright. Mr. Hargan was previously sworn in as Deputy Secretary of the Department of Health and Human Services (HHS) on October 5.

Legislative Activity –

  • On October 11, the House passed by a voice vote the National Clinical Care Commission Act (S. 920), which would establish a National Clinical Care Commission charged with evaluating and making recommendations regarding programs focused on improving care for people with metabolic syndromes and related autoimmune disorders. Having previously passed the Senate, the bill now moves to the President for signature. Press release: http://bit.ly/2yjl5hd
  • Also on October 11, Reps. Sanchez (D-CA), Meehan (R-PA), Schrader (D-OR) and Lance (R-NJ) introduced the Community Based Independence for Seniors Act (H.R. 4006), which would establish a community-based institutional special needs plan demonstration program to target home and community based care to eligible Medicare beneficiaries. Press release: http://bit.ly/2yjNTq2 Bill text: http://bit.ly/2yiXyNl
  • On October 12, House Veterans Affairs Committee Chair Roe (R-TN), and Reps. McMorris Rodgers (R-WA) and Poliquin (R-ME) introduced the Ethical Patient Care for Veterans Act of 2017 (H.R 4059), which would ensure that physicians of the Department of Veterans Affairs fulfill the ethical duty to report to State licensing authorities impaired, incompetent, and unethical health care activities. Press release: http://bit.ly/2ymsVH0

 ACA Market Stabilization, Reform, & Implementation –

  • On October 10, Senate Finance Committee Ranking Member Wyden (D-OR) sent a letter to HHS and the Department of the Treasury requesting information the Administration’s actions and decisions with respect to Oklahoma’s section 1332 reinsurance waiver. Press release: http://bit.ly/2xChk2W Letter: http://bit.ly/2xBTTqx
  • On October 11, Sen. Donnelly (D-IN) sent a letter to CMS Administrator Verma urging the Administration to commit to providing stability to health insurance markets and working together on bipartisan solutions to reduce health care costs, expand access to care, and strengthen the health care system. Press release with text of letter: http://bit.ly/2xBdxDa
  • On October 12, President Trump released an Executive Order that would direct the Departments of Labor, HHS and the Treasury to issue regulations that expand access to association health plans, short-term limited duration insurance, and allow great flexibility with respect to health reimbursement arrangements. Press release: http://bit.ly/2xBgROg EO: http://bit.ly/2yjMZtC Press releases from HHS and CMS: http://bit.ly/2yjlMXO and http://go.cms.gov/2yjoBIx NAIC statement: http://bit.ly/2xDvwIZ
  • Also on October 12, the Administration announced its intention to cease payments for cost-sharing reduction payments, effective immediately. In a statement, HHS Acting Secretary Hargan and CMS Administrator Verma argued, “We believe that the last Administration overstepped the legal boundaries drawn by our Constitution. Congress has not appropriated money for CSRs, and we will discontinue those payments immediately. HHS Press release: http://bit.ly/2ylWkkx Memo from Attorney General Sessions: http://bit.ly/2ym0ybU

Medicare –

  • On October 10, CMS released a fact sheet on the 2018 Medicare Electronic Health Record Incentive Program payment adjustment for hospitals. Fact sheet: http://go.cms.gov/2yjbLdf
  • On October 11, CMS released the Star Ratings for the 2018 Medicare Part C plans and Part D drug plans, finding that 73 percent of Medicare Advantage enrollees with prescription drug coverage will be in plans with four or more stars. Press release: http://go.cms.gov/2yj6535 Data: http://go.cms.gov/2e98gwK
  • Also on October 11, Reps. Jenkins (R-KS) and Loebsack (D-IA) led a bipartisan group of 54 Representatives in a letter to Acting HHS Secretary Wright urging him to permanently prevent Medicare’s enforcement of the direct supervision rules for outpatient therapy services at critical access hospitals and other small, rural hospitals. Press release: http://bit.ly/2xBFv1t letter: http://bit.ly/2xBDjXA
  • On October 12, HHS Office of Inspector General (OIG) released a report finding that CMS’ Medicare Advantage policies and procedures were generally effective in ensuring that capitation payments were not made after beneficiaries’ dates of death. Summary with link to report: http://bit.ly/2yjAiPA
  • Also on October 12, CMS released a bulletin providing an update on the next steps in the process for reassignments of certain low-income subsidy-eligible individuals. Bulletin: http://bit.ly/2xC62vn


  • On October 10, West Virginia announced that CMS has approved its 1115 waiver, which will expand Medicaid coverage for substance abuse treatment by allowing payments for inpatient treatment at large residential facilities, among other provisions. Press release: http://bit.ly/2xAox3y Waiver: http://bit.ly/2xzE4k9

 New Payment and Delivery System Models –

  • On October 13, CMS released the final evaluation report for the second round of the State Innovation Models Initiative model design awards. Report: http://bit.ly/2xHEEMN
  • Also on October 13, CMS released the 2016 quality and financial results for year five of the Pioneer ACO model, year one of the Next Generation ACO model, and for year one of the Comprehensive ESRD Care model. Links to download reports: http://bit.ly/2xHReeK and http://bit.ly/2xHF6ut and http://bit.ly/2jDDC1f
  • Also on October 13, CMS released preliminary reconciliation payments for performance year one of the Comprehensive Care for Joint Replacement Model. Link to download results: http://bit.ly/2cb62Yx

Mental Health and Substance Abuse –

  • On October 11, CMS released a frequently asked questions (FAQ) document providing guidance on the mental health and substance use disorder parity final rules for Medicaid and CHIP. FAQ: http://bit.ly/2xzxGcr
  • On October 12, Sens. Warren (D-MA) and Murkowski (R-AK) sent a letter to President Trump expressing concern that he has not declared the nation’s opioid epidemic a national emergency. Press release: http://bit.ly/2xBFb2x Letter: http://bit.ly/2xBgaEE
  • Also on October 12, HHS released an environmental scan and a compendium of tools and resources on implementing Medication-Assisted Treatment for opioid use disorder in rural primary care settings. Report: http://bit.ly/2ylNkfp
  • On October 13, House Energy & Commerce Committee Chair Walden (R-OR), Ranking Member Pallone (D-NJ), Subcommittee on Oversight and Investigations Ranking Member DeGette (D-CO), and Rep. McKinley (R-WV) sent a letter to the Drug Enforcement Administration (DEA) continuing its ongoing investigation into high rates of opioids in West Virginia and requesting additional information. Press release: http://bit.ly/2yqHfhJ Letter: http://bit.ly/2yqwMD2

 Veterans Health –

  • On October 10, the Department of Veterans Affairs (VA) announced the establishment of a search commission to help identify candidates for the position of VA Under Secretary of Benefits. Press release: http://bit.ly/2yjCo1S

Prescription Drugs –

  • On October 11, Food and Drug Administration (FDA) Commissioner Gottlieb released a statement outlining the FDA’s new steps to advance patient engagement in the agency’s regulatory work. Statement: http://bit.ly/2xDjSO9
  • On October 12, FDA released draft guidance for industry on request for reconsideration at the Division Level under the Generic Drug User Fee Act. Comments are due by December 11. Notice: http://bit.ly/2xHE6Xf Guidance: http://bit.ly/2xHBsk8
  • On October 13, FDA released draft guidance on assessing user fees under the Prescription Drug User Fee Amendments of 2017. Comments are due by December 12. Notice: http://bit.ly/2xHl5UU Guidance: http://bit.ly/2xHBmZO

 Natural Disasters –

  • On October 10, CMS announced efforts to support Alabama, Florida, Louisiana, and Mississippi in response to Hurricane Nate, including temporarily waiving or modifying certain Medicare, Medicaid, and CHIP requirements. Press release: http://go.cms.gov/2yjouga
  • On October 11, CMS released an FAQ providing guidance on various Medicaid payment and coverage policies in Puerto Rico and the U.S. Virgin Islands in the wake of Hurricanes Irma and Maria. FAQ: http://go.cms.gov/2yiJsf2
  • On October 15, HHS Acting Secretary Hargan declared a public health emergency in California due to wildfires. Press release: http://bit.ly/2xJ3pbb

 Misc. –

  • On October 10, U.S. Preventive Services Task Force released a draft recommendation statement on behavioral counseling to prevent skin cancer. Comments are due by November 6. Draft recommendation: http://bit.ly/2xDGfDq
  • On October 11, Sens. Warren (D-MA), Murphy (D-CT), Cortez Masto (D-NV) and 24 Senators sent a letter to National Institute of Health (NIH) Director Collins urging him to renew a recently-lapsed funding opportunity for firearm violence research. Press release: http://bit.ly/2xBiV9m Letter: http://bit.ly/2xBpUyP
  • On October 12, NIH announced the launch of the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration with 11 biopharmaceutical companies totaling $215 million as part of the Cancer Moonshot. Press release: http://bit.ly/2yjSetn
  • Also on October 12, Sens. Cortez Masto (D-NV) and Heller (R-NV) sent a letter to top insurance executives asking “that they do whatever they can to help victims of the Las Vegas shooting.” Press release with text of letter: http://bit.ly/2xDAu8w
  • On October 13, Senate Finance Committee Ranking Member Wyden (D-OR), Senate HELP Committee Ranking Member Murray (D-WA) and 25 Senate Democrats filed an amicus brief with the U.S. Court of Appeals for the Fifth Circuit in the case of Planned Parenthood of Greater Texas Family Planning and Preventive Health Services, Inc. et al v. Charles Smith et al. Press release: http://bit.ly/2xHUuab Amicus Brief: http://bit.ly/2xHmWZS
  • Also on October 13, Rep. Issa (R-CA) sent a letter to HHS Acting Secretary Hargan and Centers for Disease Control and Prevention (CDC) Director Fitzgerald calling for the agencies to provide additional funding and expertise to help local city, state and county government officials battle an ongoing hepatitis outbreak. Press release: http://bit.ly/2xJ00JC Letter: http://bit.ly/2xJ2E23