What’s Ahead: This Week


Notable Policy Events –

  • Monday, August 6 – Wednesday, August 8
    • HHS Office of the National Coordinator for Health IT (ONC), “2nd Interoperability Forum.” Additional information: https://bit.ly/2zBtak4
  • Wednesday, August 8
    • Cato Institute, “Is Obamacare Now Optional? New Rule Expands Consumer Protections in Short-Term Health Plans.” Additional information: https://bit.ly/2n7CnaQ
  • Friday, August 10
    • Center for Strategic and International Studies (CSIS) and Kaiser Family Foundation (KFF), “AIDS 2018: What Happened and What’s Next?” Additional information: https://kaiserf.am/2LPxyBR


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

 Appropriations –

  • On August 1, the Senate passed by a vote of 92-6 H.R. 6147, which provides fiscal year 2019 appropriations for the Department of the Interior, the Environmental Protection Agency, Department of Agriculture and Housing and Urban Development, among others. The omnibus appropriations bill included $5.4 billion in funding for Food and Drug Administration (FDA). The measure now moves to a House-Senate conference committee for reconciliation. Press release: https://bit.ly/2M96rhc Text: https://bit.ly/2OHE77l

 Legislative Activity –

  • On July 30, President Trump signed into law H.R. 6042, which will delay the reduction in federal medical assistance percentage (FMAP) for Medicaid personal care services furnished without an electronic visit verification system. House Energy & Commerce Committee Subcommittee on Health Chair Burgess (R-TX) Press release: http://bit.ly/2ngBGvH Text: https://bit.ly/2M9PSll
  • On August 1, Sen. Nelson (D-FL) introduced S. 3316, which would set a $5,500 per year out-of-pocket cap on traditional Medicare deductibles and copays. Press release: https://bit.ly/2KoMCkf Text: https://bit.ly/2M1b4wI
  • Also on August 1, Sen. Hirono (D-HI) and fifteen Democratic Senators introduced the Medicare and Medicaid Protection Act (S. 3330), which would protect the Medicare and Medicaid programs with respect to certain changes in reconciliation legislation. ­­­Press release: http://bit.ly/2ndHrdC
  • Also on August 1, Sen. Smith (D-MN) introduced the Mental Health Services for Students Act (S. 3337), which would provide funding to build partnerships between schools and community-based organizations that can help students get mental health services at school. Press release: https://bit.ly/2n7vMgn

 ACA Implementation –

  • On July 29, CMS approved Wisconsin’s application for a Section 1332 waiver to establish a state reinsurance program. The next day, CMS also approved Maine’s application for a 1332 waiver to establish a state reinsurance program. Press releases: https://bit.ly/2O6yX3o and https://go.cms.gov/2OEhQad
  • On August 1, Sens. Baldwin (D-WI) and Casey (D-PA) led a group of twenty Democratic Senators in a letter to HHS Secretary Azar and CMS Administrator Verma, urging them to restore funding for the ACA Navigator program. Press release: https://bit.ly/2vvD6pT Letter: https://bit.ly/2vcyiqh
  • Also on August 1, Departments of HHS, Labor, and the Treasury issued a final rule allowing for the sale and renewal of short-term, limited-duration health plans covering periods of up to 12 months, and which may be renewed for a total period of 36 months. HHS press release: https://bit.ly/2KjiOp4 Fact sheet: https://go.cms.gov/2vlRYaq Final rule: https://go.cms.gov/2MbncIn
  • On August 3, CMS released guidance to states encouraging states to allow issuers to offer and market plans that will be available off-Exchange and which do not include any cost-sharing reduction “load.” Guidance: https://go.cms.gov/2vDtMR6

 Medicare –

  • On July 30, HHS Office of Inspector General (OIG) released a study on how vulnerabilities in the Medicare hospice program affect quality care and program integrity. OIG recommended that CMS strengthen its survey process to better ensure than hospices provide beneficiaries with needed services and quality care. Summary: https://bit.ly/2OHF8fF Report: https://bit.ly/2AsYWQD
  • On July 31, CMS announced that the average basic premium for a Medicare Part D prescription drug plan is projected to decline in 2019. The projected $32.50 is down from $33.59 in 2018. Press release: https://go.cms.gov/2veKjvd
  • Also on July 31, U.S. Government Accountability Office (GAO) released a report on the status of HHS’ implementation of required prior authorization medical reviews and provider education for chiropractic services. The report showed that Medicare has not yet implemented legislation requiring that chiropractic services be subject to prior authorizations. Summary: https://bit.ly/2vxlYjG Report: https://bit.ly/2MktghK
  • Also on July 31, CMS issued a series of final rules updating the Medicare Skilled Nursing Facility (SNF) Prospective Payment System (PPS), the Inpatient Rehabilitation Facility (IRF) PPS, and the Inpatient Psychiatric Facilitates (IPF) PPS for FY19. The rules all include policies that continue a commitment to shift Medicare payments from volume to value, and reduce provider burden. The SNF final rule makes updates to the SNF Value-Based Purchasing Program (VBP) and SNF Quality Reporting Program (QRP); the IRF increases payment rates by 1.35 percent, and the IPF PPS increases payment rates by 101 percent. SNF Fact sheet: https://go.cms.gov/2LVlMoO SNF Final rule: https://bit.ly/2vyfr8y IRF Fact sheet: https://go.cms.gov/2AAHQAD IRF Final rule: https://bit.ly/2n7kNDN IPF Fact sheet: https://go.cms.gov/2AAHQAD IPF Final rule: https://bit.ly/2MdVuL3
  • Also on August 1, CMS issued a final rule updating the Hospice Wage Index, payment rates, and cap amount for FY19. The rule also makes conforming regulations to recognize physician assistants as designated hospice attending physicians effective January 1, 2019. Final rule: https://bit.ly/2MdUCpL
  • On August 2, CMS finalized a rule updating the Medicare Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) PPS for FY19. CMS is increasing payments to acute care hospitals by an average of 3 percent and to LTCH by 1.35 percent. The rule addresses interoperability, hospital price transparency, and quality reporting measures. Press release: https://go.cms.gov/2n7CAe4 Fact sheet: https://go.cms.gov/2LNrAkJ Final rule: https://bit.ly/2LI6hjF
  • Also on August 2, CMS announced the extension of temporary moratoria on enrollment of Part B non-emergency ground ambulance suppliers and home health agencies in designated geographic locations. Announcement: https://bit.ly/2LOVeWI
  • Also on August 2, Rep. Schakowsky (D-IL) and Sen. Blumenthal (D-CT) penned a letter to CMS Administrator Verma, urging CMS to full incorporate new staffing data into nursing homes’ publicly-reported Five-Star Quality Rating System, to further improve the accuracy of staffing level data, and to reduce the complexity of the rating system. Press release: https://bit.ly/2MhfnB9 Letter: https://bit.ly/2vwTjvb
  • Also on August 2, Rep. Griffith (R-VA) led a group of 83 members in a letter to HHS Secretary Azar urging HHS to move forward with a proposal to “meaningfully address skyrocketing drug prices by specifically addressing pharmacy direct and indirect remuneration (DIR) fees in the Medicare part D program.” Letter: http://bit.ly/2vHlxU6

 New Payment and Delivery System Reforms –

  • On July 31, CMS posted the list of selected Care Transformation Organizations for Maryland’s Total Cost of Care Model. List: https://bit.ly/2AKGxzc

Mental Health and Substance Use –

  • On July 31, HHS released a final report on examining substance use disorder treatment demand and provider capacity in a changing health care system. The report shows a significant challenge in increasing demand for treatment among those with SUD and in providing an adequate workforce. Report: https://bit.ly/2vALjcm
  • Also on July 31, Rep. Sanchez (D-CA) led a group of 47 bipartisan members of Congress in a letter to Centers for Disease Control and Prevention (CDC) Director Redfield, urging CDC to ensure that all jurisdictions pre-approved to receive public health crisis funding are able to apply for additional funding to address the opioid epidemic. Press release and letter: https://bit.ly/2MfXGlw
  • On August 1, Sens. Grassley (R-IA), Warren (D-MA), Capito (R-WV), and Feinstein (D-CA), along with Reps. Stivers (R-OH) and Clark (D-MA) sent a letter to Drug Enforcement Administration (DEA) Acting Administrator Dhillon to emphasize the importance of updating “partial fill” regulations for controlled substances. Press release: https://bit.ly/2Maf1fG Letter: https://bit.ly/2vqjqUu
  • On August 3, Food and Drug Administration (FDA) Commissioner Gottlieb announced draft guidance on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes. Statement: https://bit.ly/2ADDvwf Draft guidance: https://bit.ly/2ADRYsd Commissioner’s blog post: https://bit.ly/2LWcJUA
  • Also on August 3, House Energy and Commerce Full Committee Chair Walden (R-OR) and Ranking Member Pallone (D-NJ), Subcommittee on Oversight and Investigations Chair Harper (R-MS), Ranking Member DeGette (D-CO), and Vice Chair Griffith (R-VA), along with Full Committee Vice Ranking Member Castor (D-FL) penned a letter to three opioid manufacturers regarding their role in the opioid crisis. Press release: https://bit.ly/2LSG0A2 Letter to Insys Therapeutics, Inc.: https://bit.ly/2AP8k1t Letter to Mallinckrodt Pharmaceuticals: https://bit.ly/2n9hkop Letter to Purdue Pharma L.P.: https://bit.ly/2vd0h94

Drug Prices and Regulation

  • On July 31, Food and Drug Administration (FDA) published the rates for biosimilar user fees for FY19. The next day, FDA published the FY19 prescription drug user fees. Notices: https://bit.ly/2OEj59n and https://bit.ly/2LSNMKv
  • On August 1, Sen. McCaskill (D-MO) released a report finding that nearly $3 billion per year could be saved on the twenty most commonly prescribed drugs if Medicare had the authority to directly negotiate drug prices. Press release: https://bit.ly/2MhFibG Report: https://bit.ly/2vvsc3E
  • Also on August 1, House Energy & Commerce Chair Walden (R-OR), Health Subcommittee Chair Burgess (R-TX), and Oversight & Investigations Subcommittee Chair Harper (R-MS) sent letters to nine contract pharmacies that participate in the 340B Drug Pricing Program, requesting information about their participation in the program. Press release: https://bit.ly/2MdOePu Letters: https://bit.ly/2vtwMiR

 Health IT –

  • On July 31, Office of the National Coordinator for Health IT (ONC) posted an annual Request for Comments on the Interoperability Standards Advisory. Comments are due October 1, 2018. Blog: https://bit.ly/2O7ERS0
  • On August 1, National Institute of Standards and Technology (NIST) released guidance on securing electronic health records on mobile devices. The guidance focuses on data handled by providers rather than patients. Guidance: https://bit.ly/2M0BE9h
  • On August 2, Federal Communications Commission (FCC) released a Notice of Inquiry on the Commission’s proposal to create a $100 million Connected Care Pilot Program. Notice: https://bit.ly/2LcFiwJ


  • On July 30, CDC released data on long-term trends in health insurance coverage in the United States between 1968 and 2017, showing a steady decline in the uninsured rate beginning in 2010. Data: https://bit.ly/2vi3hBt
  • On July 31, Minority Leader Pelosi (D-CA) penned a letter to HHS Secretary Azar urging the withdrawal of the department’s Title X “gag rule” which would severely roll back women’s access to health care. Press release: https://bit.ly/2AAVPq5 Letter: https://bit.ly/2LJlRMO
  • Also on July 31, HHS OIG released a guide with solutions to reduce fraud, waste, and abuse in HHS programs. The guide includes the OIG’s top unimplemented recommendations. Report: https://bit.ly/2OGPtZc
  • On August 1, HHS awarded $2 million to the American College of Obstetricians and Gynecologists to reduce maternal morbidity and mortality through the Alliance for Innovation on Maternal Health (AIM). Press release: https://bit.ly/2KpVeqC
  • On August 2, HHS announced the 96 grantees to whom the department intends to award Title X family planning service grants for FY18. Twelve of the intended awardees are new to Title X. Press release: https://bit.ly/2KozgV9