What’s Ahead: This Week


  • Wednesday, September 6
    • Senate HELP Committee, “Stabilizing Premiums and Helping Individuals in the Individual Insurance Market for 2018: State Insurance Commissioners.”
    • Senate Homeland Security and Governmental Affairs Committee, “The History and Current Reality of the U.S. Health Care System.”
  • Wednesday, September 6 – Thursday, September 7
    • Senate Appropriations Committee, Labor, Health and Human Services, Education, and Related Agencies Subcommittee, “Markup of the Labor, Health and Human Services, Education, and Related Agencies Appropriations Act, 2018.”
  • Thursday, September 7
    • Senate HELP Committee, “Stabilizing Premiums and Helping Individuals in the Individual Market for 2018: Governors.”
    • Senate Finance Committee, “The Children’s Health Insurance Program: The Path Forward.”

Notable Policy Events –

  • Tuesday, September 5 – Wednesday, September 6
    • HHS Office for Civil Rights and the National Institute for Standards and Technology, “10th Annual Safeguarding Health Information: Building Assurance through HIPAA Security.” Additional information: http://bit.ly/2wuPRUk
  • Thursday, September 7 – Friday, September 8
    • HHS Physician-Focused Payment Model Technical Advisory Committee, “Public Meeting.” Additional information: http://bit.ly/2mn4L9v
    • Medicare Payment Advisory Committee (MedPAC), “September Public Meeting.” Additional information: http://bit.ly/2eXhtHO
  • Friday, September 8
    • Center for Medicare and Medicaid Innovation (CMMI), “Behavioral Health Payment and Care Delivery Innovation Summit.” Additional information: http://bit.ly/2wLoINa
    • American Enterprise Institute (AEI) and the Center for American Progress (CAP), “Govs. Hickenlooper and Kasich Discuss Bipartisan Proposal to Stabilize Health Insurance Market.” Additional information: http://ampr.gs/2xApiuD
    • Alliance for Health Policy, “Stabilizing the Individual Market in Uncertain Times.” Additional information: http://conta.cc/2wtFnSD

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

 ACA Implementation and Market Stabilization –

  • On August 22, Iowa submitted a final 1332 demonstration waiver to CMS for approval; the waiver would redistribute the estimated subsidies allocated to the state in 2018 between a reinsurance program and per-member-per-month premium credits adjusted based on age and income. Waiver: http://bit.ly/2wtE09e
  • On August 24, Congressional Budget Office (CBO) Director Hall sent a letter to Rep. MacArthur (R-NJ) describing the steps that the CBO takes to ensure its work is objective, impartial, and nonpartisan and providing answers to questions about its analysis of the effects of the American Health Care Act (H.R. 1628). Press release: http://bit.ly/2vIDeBr Letter: http://bit.ly/2vIuNGp
  • On August 29, the leaders of 12 state-based exchanges wrote a letter to Senate HELP Committee Chair Alexander (R-TN) and Ranking Member Murray (D-WA) urging them to consider consistent funding of cost-sharing reduction payments, to establish a permanent, federal reinsurance program, to maintain flexibility over the use of 1332 waivers, and to promote stability through a commitment to certainty and long-term solutions to market stabilization. Letter: http://bit.ly/2wodFXs
  • On August 30, Governors Hickenlooper (D-CO), Kasich (R-OH), Bullock (D-MT), McAuliffe (D-VA), Bel Edwards (D-LA), Wolf (D-PA), Walker (I-AK), and Sandoval (R-NV) sent a letter to House Speaker Ryan (R-WI), Minority Leader Pelosi (D-CA), Senate Majority Leader McConnell (R-KY) and Minority Leader Schumer (D-NY) urging them to take immediate steps to make coverage more stable and affordable, through “(1) immediate federal action to stabilize markets, (2) responsible reforms that preserve the recent coverage gains and control costs, and (3) an active federal/state partnership that is based on innovation and a shared commitment to improve overall health system performance.” Letter: http://bit.ly/2wmf7LB
  • Also on August 30, CMS posted an update to the Health Insurance Exchanges Issuer County Map, which shows that nationwide zero counties are projected to have no issuers and 1,476 counties are projected to have one issuer in 2018. Press release: http://go.cms.gov/2wMMGaM
  • On August 31, CMS announced a plan to spend $10 million on educational activities for the upcoming 2018 Open Enrollment period, a 90 percent reduction in funding. CMS also announced it will reduce funding for Health Insurance Navigators from $63 million to $36 million. Bulletin: http://go.cms.gov/2wsUVpP

 Medicare –

  • On August 24, HHS Office of the Inspector General (HHS OIG) released an early alert that CMS has inadequate procedures to ensure that incidents of potential abuse or neglect at skilled nursing facilities are identified and reported in accordance with applicable requirements. Summary with link to report: http://bit.ly/2wLIWGz
  • On August 28, HHS OIG released a report finding that over the first three years of the Medicare Shared Savings Program, 428 participating Accountable Care Organizations served 9.7 million beneficiaries and achieved a net spending reduction of nearly $1 billion. Summary with link to report: http://bit.ly/2wLZApn
  • On August 30, CMS released inpatient and outpatient charge data for fiscal year 2015. Data: http://go.cms.gov/2wtM5rO and http://go.cms.gov/2wt6tJH
  • On August 31, Sens. Collins (R-ME) and Shaheen (D-NH), co-chairs of the Senate Diabetes Caucus, sent a letter to CMS Administrator Verma urging the agency to provide Medicare coverage for clinically appropriate diabetes treatment. Press release: http://bit.ly/2wsXPLe  Letter: http://bit.ly/2wtFnSw
  • Also on August 31, CMS released a notice announcing changes made by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) to section 1882 of the Social Security Act, which restricts Medicare supplemental (Medigap) policies from covering Medicare Part B deductibles for newly eligible Medicare beneficiaries. Notice: http://bit.ly/2wtoKXm

 New Payment and Delivery System Models –

  • On August 21, CMS announced the withdrawal of the Awareness Track Funding Opportunity for the Accountable Health Communities Model because CMS did not receive enough qualified applications to move forward with the Awareness Track. CMS does not intend to open a new funding opportunity for the model at this time. More information: http://bit.ly/2wosdZu
  • On August 30, CMS published a statement iterating its commitment to further exploring the development of innovative pricing systems that reflect the value delivered to patients. Press release: http://go.cms.gov/2wMsWnq
  • Also on August 30, CMS posted the second annual report for the second round of Health Care Innovation Awards and seven year-three annual evaluation reports. Reports: http://bit.ly/2wldbTw and http://bit.ly/2wmqeEp

 Mental Health and Substance Abuse –

  • On August 21, Food and Drug Administration (FDA) announced that it is carefully evaluating prescription opioid medications approved to treat cough in children, based on suggestions from a roundtable with stakeholders earlier this year. Press release: http://bit.ly/2wouxzJ
  • On August 22, Substance Abuse and Mental Health Services Administration (SAMHSA) published a report finding that opioid treatment programs in the United States had increased by 39 percent from 2003 to 2016. Press release: http://bit.ly/2wotfol
  • On August 25, HHS released a notice of intent to establish a Pain Management Best Practices Interagency Task Force and a request for nominations for members. Applications are due by September 27. Notice: http://bit.ly/2wGsUgT
  • On August 30, SAMHSA announced that states can reallocate previously awarded formula and discretionary grants to provide opioid use disorder treatment when no other funds are available in areas of Texas and Louisiana that have been affected by Hurricane Harvey. Press release: http://bit.ly/2vN9kuU
  • On September 1, Centers for Disease Control and Prevention (CDC) released a report finding that overdose deaths quadrupled from 8,050 in 1999 to 33.0909 in 2015 and accounted for 63 percent of drug overdose deaths in the U.S. in 2015. Report: http://bit.ly/2wtvS5Y

Prescription Drugs –

  • On August 23, Sen. Blumenthal (D-CT) sent a letter to Federal Trade Commission (FTC) Acting Chair Ohlhausen expressing concern that pharmaceutical company mergers may be contributing to drug shortages and requesting information on whether the FTC has the authority to require companies to implement a plan safeguarding against drug shortages as part of a merger agreement. Letter: http://bit.ly/2wuG0xE
  • On August 29, Food and Drug Administration (FDA) published the Generic Drug User Fee Rates and the Medical Device User Fee Rates for FY 2018. Notices: http://bit.ly/2vNctuV and http://bit.ly/2vNuid3

 Veterans Health –

  • On August 21, Department of Veterans Affairs (VA) announced that it plans to propose changes to regulations for its State Veterans Home Construction Grant Program to make it easier for states to receive VA funding to construct veterans’ homes in rural areas. Press release: http://bit.ly/2wooF9G
  • On August 29, VA published updates to the Cost-Based and Inter-Agency billing rates for medical care or services provided by the VA. Notice: http://bit.ly/2vNSYSY
  • On August 31, VA announced a new partnership to increase access to lung screening for veterans. The project brings together experts from within and outside VA to develop the VA-PALS Implementation Network (VA-Partnership to increase Access to Lung Screening) with the goal of developing early-detection programs for lung cancer, a malignancy with an 80 percent cure rate when caught early. Press release: http://bit.ly/2vMKtHU

 Hurricane Harvey –

  • On August 26, HHS declared a public health emergency in Texas in response to Hurricane Harvey. On August 28, HHS also declared a public health emergency in Louisiana. Press releases: http://bit.ly/2wlQ2k2 and http://bit.ly/2wtej6g and http://bit.ly/2wtqiAJ
  • On August 30, CMS announced efforts that are underway to support Texas and Louisiana in response to Hurricane Harvey. Efforts include working in close coordination with the Kidney Community Emergency Response Network and waiving or modifying certain administrative requirements for specific types of providers in impacted counties and geographical areas. Press release: http://go.cms.gov/2wMeiN5

 Misc. –

  • On August 22, CMS Administrator Verma penned a blog post describing the importance of clinicians in healthcare, and announcing that over the next few months, CMS “will be announcing additional initiatives to ease the burden our government places on healthcare providers.” Blog post: http://bit.ly/2dNwniZ
  • Also on August 22, Sen. Markey (D-MA) led a group of 7 Democratic Senators in a letter to FDA Commissioner Gottlieb urging him to ban menthol cigarettes, citing FDA research finding that “menthol cigarettes pose a public health risk above that seen with non-menthol cigarettes.” Press release: http://bit.ly/2wuxqiz Letter: http://bit.ly/2wuyOSn
  • On August 29, CDC published a report finding that in the first 3 months of 2017, 28.1 million (8.8%) people of all ages were uninsured – 0.5 million fewer than in 2016 and 20.5 million fewer than in 2010. Report: http://bit.ly/2vN2DsV On August 31, Centers for Disease Control and Prevention released a report finding that five states now have more than 35 percent of adults with obesity. Report: http://bit.ly/2wtNP4y
  • On August 30, FDA announced the approval of the first gene therapy for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia. Press release: http://bit.ly/2vNsOQ7
  • On August 31, FDA released guidance on the use of real-world evidence to support regulatory decision-making for medical devices, which describes the circumstances when real-world evidence can be used, and the scientific criteria that must be fulfilled. Notice: http://bit.ly/2wtuv7j Guidance: http://bit.ly/2wtNAGv