What’s Ahead: This Week

Notable Policy Events –

  • Monday, August 13
  • Thursday, August 16
    • Bipartisan Policy Center (BPC), “Framing a Pathway for Integrating Behavioral and Clinical Health Care.” Additional information: https://bit.ly/2Ma4Wmd

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

 ACA Implementation –

  • On August 6, Sen. Blumenthal (D-CT) sent a letter to Connecticut Insurance Commissioner Wade, urging her to ban the issuance of short-term limited duration insurance plans as expanded by the Trump administration. Letter: https://bit.ly/2B0dYOe
  • On August 7, House Oversight & Government Reform Committee Ranking Member Cummings (D-MD) sent a letter to Department of Health and Human Services (HHS) HHS Secretary Azar and CMS Administrator Verma requesting information regarding to the scrubbing of content related to the Affordable Care Act (ACA) from the Medicare.gov website. Press release: https://bit.ly/2AXZbDL Letter: https://bit.ly/2noorJx
  • On August 8, CMS issued a proposed additional rule to adopt the previously established statewide average premium risk adjustment methodology for the 2018 benefit year. Comments are due by September 7. Press release: https://go.cms.gov/2ATTmXZ Proposed rule: https://bit.ly/2vTksZt
  • On August 9, CMS released guidance for exchange qualified health plans and stand-alone dental plan issuers on special enrollment periods for individuals affected by emergency and major disaster declarations by the Federal Emergency Management Agency. Guidance: https://go.cms.gov/2vTLhwy

 Medicare –

  • On August 8, HHS Office of Inspector General (OIG) released a report on the accuracy, precision, and consistency in reporting of Open Payments program data, finding that of 11.9 million records published on the program’s website for 2015, less than 1 percent were missing required data elements. Summary: https://bit.ly/2MBFOBy Report: https://bit.ly/2vCxv1W Grassley press release: https://bit.ly/2Osh9jH
  • On August 9, CMS released a proposed rule to overhaul Medicare’s Shared Savings Program (MSSP), which will now be called Pathways to Success. The rule would streamline the program to two tracks, Basic and Enhanced, and would begin on July 2, 2019. Comments are due by October 16. Press release: https://go.cms.gov/2KFP3yV Fact sheet: https://go.cms.gov/2OsHkqo Administrator Verma’s blog post: https://bit.ly/2MlARQN Proposed rule: https://bit.ly/2vyR8rM

 Medicaid –

  • On August 7, Congressional Budget Office (CBO) released a report exploring the growth of Medicaid managed care, finding that between 1999 and 2012, the portion of all Medicaid beneficiaries enrolled in managed care grew from 63 percent to 89 percent, while the share of managed care’s share of spending grew from 15 percent to 37 percent. Summary: https://bit.ly/2ASNrSO Report: https://bit.ly/2np2ZEc
  • Also on August 7, the Massachusetts congressional delegation penned a letter to CMS Administrator Verma expressing concern with the agency’s proposal to restrict home care workers’ ability to voluntarily have union dues automatically deducted from their paychecks. Press release: https://bit.ly/2B4NAD0 Letter: https://bit.ly/2vNPzpc
  • On August 8, HHS released a report finding that the demand for Medicaid long-term services and supports (LTSS) is likely to increase dramatically over time and that LTSS accounts for about a third of total Medicaid expenditures. Report: https://bit.ly/2MAPVqf
  • On August 10, CMS issued guidance to state health officials regarding expectations for Medicaid and Children’s Health Insurance Program (CHIP) data and ongoing Transformed-MSIS (T-MSIS) implementation. Guidance: https://bit.ly/2MhUQj2

 New Payment and Delivery System Reforms –

  • On August 6, CMS released the application for the Medicare Advantage Qualifying Payment Arrangement Incentive (MAQI) Demonstration. Applications are due by September 6. Background: https://bit.ly/2MflNUw Application: https://bit.ly/2OpP5NF

Mental Health and Substance Use –

  • On August 6, Food & Drug Administration (FDA) issued new scientific draft guidance aimed at encouraging more widespread innovation and development of novel medication-assisted treatment (MAT) drugs for the treatment of opioid use disorder (OUD). Press release: https://bit.ly/2KyG5n1 Draft guidance: https://bit.ly/2M7aJth
  • On August 8, HHS released a report substance use disorder treatment, including key levers states use to expand or improve access to Medication-assisted treatment (MAT), common themes among financing and workforce policies, and policy levers to different settings in which a patient could start MAT. Report: https://bit.ly/2nmGNdQ
  • On August 9, Centers for Disease Control and Prevention (CDC) released a report showing that the number of pregnant women with opioid use disorder (OUD) at labor and delivery more than quadrupled from 1999 to 2014. Press release: https://bit.ly/2M3z8Qu Report: https://bit.ly/2uQS769
  • Also on August 9, National Institutes of Health (NIH) released a study finding that clinicians are more likely to reduce the number and dose of opioid drugs their prescribe after learning that one of their patients had died from an overdose than those not notified. Press release: https://bit.ly/2OYhYla
  • On August 10, CDC released a report showing that during 2012-2016, the rate of EMS naloxone administration events increased 75.1 percent, from 576.3 to 1004.4 per 100,000 EMS events. Report: https://bit.ly/2MjnwIv

Drug Prices and Regulation

  • On August 7, CMS released guidance that newly authorizes Medicare Advantage plans to use step therapy for Part B drugs as part of a “patient-centered care coordination program.” The change will only apply to newly prescribed medications and will take effect January 1, 2019. Press release: https://go.cms.gov/2vAtRG7 Fact sheet: https://go.cms.gov/2M2O4P4 Guidance: https://go.cms.gov/2M2h21m
  • On August 8, FDA approved several strengths of potassium chloride oral solution as the first generic drugs to receive the agency’s new Competitive Generic Therapy (CGT) designation. This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition. Press release: https://bit.ly/2Me4UJV
  • On August 9, CMS issued guidance regarding the Medicaid Drug Rebate Program’s line extension unit rebate amount calculation, as revised by the Bipartisan Budget Act of 2018, and which goes into effect on October 1. Letter to State Technical Contacts: https://bit.ly/2KJCeUc Letter to Manufacturers: https://bit.ly/2vx2pZs
  • Also on August 9, OIG released a report finding CMS’ Part B retroactive price-substitution policy saved Medicare and its beneficiaries $13.1 million over one year. Summary: https://bit.ly/2MyfdoY Report: https://bit.ly/2MbJk8Y
  • Also on August 9, OIG released a report finding that Part D spending for compounded topical drugs was 24 times higher in 2016 than it was in 2010, and recommending that CMS clarify Part D policies for coverage of compounded topical drugs. Summary: https://bit.ly/2AWjjpx Report: https://bit.ly/2vwgrLb
  • Also on August 9, Senate Finance Committee Chair Hatch (R-UT) and House Energy and Commerce Committee Chair Walden (R-OR) penned a letter to Office of Management and Budget (OMB) Director Mulvaney, urging him to consider the full economic effects of a proposed HHS rule that would alter the use of rebates that are common in negotiations between drug manufacturers and pharmacy benefit managers (PBMs). Press release: https://bit.ly/2MgkSDu Letter: https://bit.ly/2M8FcYd

Military & Veterans’ Health –

  • On August 8, Department of Veterans Affairs (VA) released the Spanish version of the application for health benefits as part of VA’s effort to simplify and improve the health care enrollment process for veterans. Press release: https://bit.ly/2nlexIL Form: https://bit.ly/2uYILF1
  • Also on August 8, House Veterans Affairs Committee Ranking Member Walz (D-MN) sent a letter to VA Secretary Wilkie requesting that VA provide any and all communications between VA officials and Ike Perlmutter, Bruce Moskowitz, and Marc Sherman to Congress without delay. Press release: https://bit.ly/2Mz9AXR Letter: https://bit.ly/2OlOQ6m
  • Also on August 8, Senate Veterans Affairs Committee Ranking Member Tester (D-MT) sent a letter to VA Secretary Wilkie requesting VA to quickly establish community care networks through the VA MISSION Act. Press release: https://bit.ly/2MxrF8G Letter: https://bit.ly/2AYwOVO
  • On August 9, the New Hampshire congressional delegation sent a letter to VA Secretary Wilkie urging him to take swift action to implement the recommendations of the VA New Hampshire Vision 2025 Task Force, which was convened to reexamine VA care in the state and make recommendations for a path forward. Press release: https://bit.ly/2vyGl0Q Letter: https://bit.ly/2nyDNvn

 Health IT –

  • On August 6, CMS Administrator Verma delivered remarks at the Office of the National Coordinator for Health IT (ONC) Interoperability Forum, highlighting CMS’ vision to improve health record interoperability and phase out the use of fax machines. Transcript: https://go.cms.gov/2vSpC7R
  • On August 7, ONC announced that National Council for Prescription Drug Programs (NCPDP) has formally taken over the stewardship of the e-prescribing testing tool approved for use under the ONC Health IT Certification Program. Blog: https://bit.ly/2OT3FhE


  • On August 7, HHS released a study on pediatric emergency department (ED) visits in 2015. The study found that children had a lower rate of ED visits than adults in 2015, and that fewer than 5 percent of pediatric ED visits resulted in admission to the same hospital. Report: https://bit.ly/2Ollp4n
  • On August 8, CDC released a report showing that the U.S. perinatal mortality rate was essentially unchanged from 2014 through 2016. There were 6 perinatal deaths per 1,000 births and late fetal deaths in 2016. Report: https://bit.ly/2AYstCe
  • Also on August 9, CDC released a report showing that, between 2007 and 2017, enrollment in high-deductible health plans (HDHPs) with a health savings account (HSA) increased from 4.2 percent to 18.9 percent. In the same timeframe, enrollment in HDHPs without an HSA increased from 10.6 percent to 24.5 percent. Report: https://bit.ly/2OpViJt
  • Also on August 9, HHS Secretary Azar delivered remarks at the 45th American Legislative Exchange Council (ALEC) Annual Meeting in New Orleans, LA. His speech focused on health IT, price and quality transparency, new models in Medicare and Medicaid, and removing government burdens. Press release: https://bit.ly/2MmVGei Transcript: https://bit.ly/2MB5SwL