What’s Ahead: This Week

Hearings –

  • Tuesday, October 3
    • House Energy & Commerce Committee, Subcommittee on Health, “Examining Patient Access to Investigational Drugs.”
  • Wednesday, October 4
    • Senate Finance Committee, “Open Executive Session to Consider the Keep Kids’ Insurance Dependable and Secure (KIDS) Act of 2017.”
  • Thursday, October 5
    • Senate HELP Committee, “The Federal Response to the Opioid Crisis.”

 Notable Policy Events –

  • Monday, October 2 – Wednesday, October 4
    • American Telemedicine Association, “Fall Forum: EDGE 2017.” Additional information: http://bit.ly/2wUSkUd
  • Tuesday, October 3
    • HHS Office of the National Coordinator for Health IT, “National Health IT Week Celebration of Advancements in Interoperability and Usability.” Additional information: http://bit.ly/2wUZ5W9
    • Politico, “Medicaid Innovation: An Integrated Approach.” Additional information: http://politi.co/2xFfnWI
    • Patient-Centered Clinical Decision Support Learning Network, “2017 Annual Conference: Realizing the Potential of Patient-Centered Clinical Decision Support.” Additional information: http://bit.ly/2xLATt5
    • The Atlantic, “At What Cost? An Atlantic Forum on Prescription Drugs.” Additional information: http://theatln.tc/2xLTunb
  • Wednesday, October 4
    • CHIME & the Association for Executives in Healthcare Information Security, “The Critical State of Healthcare Cybersecurity: Leveraging the Recommendations Made by the Health Care Industry Cybersecurity Task Force.” Additional information: http://bit.ly/2wUZhol
    • The Hill, “Innovating to Improve Patient Health: A Solutions Conversation.” Additional information: http://bit.ly/2fvCZ6c
    • Brookings Institution, “What Does 21st Century Medicine Look Like?” Additional information: http://brook.gs/2xLixqd
  • Wednesday, October 4 – Friday, October 6
    • National Association of Accountable Care Organizations (NAACOs), “NAACOs Fall 2017 Conference.” Additional information: http://bit.ly/2xKODE7
  • Thursday, October 5 – Friday, October 6
    • Medicare Payment Advisory Commission (MedPAC), “October Public Meeting.” Additional information: http://bit.ly/2fxpAdX

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

Administration –

  • On September 29, HHS Secretary Price announced his resignation. Don Wright, the current Acting Assistant Secretary for Health has been designated Acting Secretary. Press release: http://bit.ly/2xKHxOz

FY 2018 Budget Resolution

  • On September 29, the Senate Budget Committee released the text of the fiscal 2018 Budget Resolution, which includes reconciliation instructions allowing the Senate Finance Committee to add up to $1.5 trillion to the deficit over the next ten years. Press release: http://bit.ly/2fxyNCT Summary: http://bit.ly/2fxyRT9 Budget Resolution: http://bit.ly/2fxyEiZ

Legislative Activity –

  • On September 25, the Senate passed by unanimous consent the Department of Veterans Affairs Expiring Authorities Act of 2017 (H.R. 3819), which extends certain expiring provisions of law administered by the Secretary of Veterans Affairs. Having previously passed the House, the bill now moved to the President for signature. Press releases: http://bit.ly/2wVgHRI and http://bit.ly/2wVi8zn Section-by-section: http://bit.ly/2wUKPwp
  • On September 25, Reps. Franken (D-FL) and Ros-Lehtinen (R-FL) introduced the Protecting Seniors During Disasters Act (H.R. 3820), which would establish a National Advisory Committee on seniors and disasters. Sens. Rubio (R-FL) and Nelson (D-FL) previously introduced companion legislation. Press release: http://bit.ly/2fyBF2E
  • On September 26, the Senate unanimously passed the Creating High-quality Results and Outcomes Necessary to Improve Chronic (CHRONIC) Care Act (S. 870), which would implement Medicare payment policies designed to improve management of chronic disease, streamline care coordination, and improve quality outcomes without adding to the deficit. The bill now moves to the House for consideration. Press release: http://bit.ly/2xGM7Pb
  • Also on September 26, the House passed by a voice vote the Increasing Opportunity through Evidence-Based Home Visiting Act (H.R. 2824), which would extend the Maternal, Infant, and Early Childhood Home Visiting Program. The bill now moves to the Senate for consideration. Press release: http://bit.ly/2xGeTQ2
  • Also on September 26, Rep. Dunn (R-FL) and four bipartisan cosponsors introduced the Veterans Opioid Abuse Prevention Act (H.R. 3832), which would direct the Secretary of Veterans Affairs to enter into a memorandum of understanding with the executive director of a national network of state-based prescription monitoring programs under which Department of Veterans Affairs providers shall query such network. Press release: http://bit.ly/2xGZTBt
  • On September 27, Sens. Blumenthal (D-CT) and Blunt (R-MO) introduced the Veteran PEER Act (S. 1873), which would require the Secretary of the Department of Veterans Affairs to carry out a program to establish peer specialists in patient aligned care teams at medical centers of the Department of Veterans Affairs. Press release: http://bit.ly/2fyhDFp
  • On September 28, Sens. Ernst (R-IA), Tillis (R-NC), Grassley (R-IA), and Cornyn (R-TX) introduced the Prioritizing Veterans’ Access to Mental Health Care Act (S. 1881), which would expand eligibility for health care under the Veterans Access, Choice, and Accountability Act of 2014 to include certain veterans seeking mental health care. Press release: http://bit.ly/2fyPgqE
  • Also on September 28, Sens. Markey (D-MA), Durbin (D-IL), Manchin (D-WV), Brown (D-OH), Hassan (D-NH) and Hassan (D-NH) introduced the Opioid Quota Openness, Transparency, and Awareness Act (Opioid QuOTA Act) (S. 1882), which would amend the Controlled Substances Act to require the Attorney General to make procurement quotas for opioid analgesics publicly available. Press release: http://bit.ly/2fyxKTm
  • Also on September 28, Sens. Blunt (R-MO) and Stabenow (D-MI) and 8 bipartisan cosponsors introduced the Community Health Investment, Modernization, and Excellence (CHIME) Act (S. 1889), which would reauthorize and extend funding for community health centers and the National Health Services Corps. Press release: http://bit.ly/2fxzMDg
  • Also on September 28, Reps. Butterfield (D-NC), Stewart (R-UT) and Lujan (D-NM) introduced the National Health Service Corps Strengthening Act of 2017 (H.R. 3862), which would extend funding for the National Health Service Corps program. Press release: http://bit.ly/2fy5qQV Bill text: http://bit.ly/2fyO1aY
  • Also on September 28, Reps. Smucker (R-PA) and Evans (D-PA) introduced the Strengthening our Pediatric Workforce Act (H.R. 3888), which would provide grants for additional residency slots in children’s hospitals graduate medical education programs. Press release: http://bit.ly/2xKNxa3
  • Also on September 28, Reps. Walberg (R-MI) and Welch (D-VT) introduced H.R 3891, which would clarify the authority of State Medicaid fraud and abuse control units to investigate and prosecute cases of Medicaid patient abuse and neglect in any setting. Press release: http://bit.ly/2fxy3xM

 ACA Market Stabilization & Reform –

  • On September 25, Sens. Graham (R-SC), Cassidy (R-LA), Heller (R-NV), and Johnson (R-WI) released an updated version of their ACA repeal and replacement proposal, which included several changes to the funding formula and revisions to the waiver provisions to provide states with greater regulatory flexibility. Updated section-by-section and bill text: http://bit.ly/2xGpFWw and http://bit.ly/2xGd99q
  • Also on September 25, the Congressional Budget Office released a preliminary analysis of the Graham-Cassidy proposal, finding that it would reduce the deficit by $133 billion over the period from 2017 to 2026, but would result in coverage losses. CBO said that it would need more time to project further detail on coverage and costs. Analysis: http://bit.ly/2wUZA2t
  • On September 27, the Problem Solvers Caucus wrote to Congressional leadership to “reiterate their desire to see Congress consider and implement bipartisan, common sense health care principles to lower premiums and stabilize the health insurance marketplace for American families and businesses.” Press release with text of letter: http://bit.ly/2xJbLmB
  • Also on September 27, the National Governors Association released a statement applauding the renewed commitment of the HELP Committee Chair and Ranking Member to ensure the immediate stabilization of the insurance market. Statement: http://bit.ly/2xIQwBg
  • On September 28, Sen. Daines (R-MT) introduced the Repeal and Refund Act (S. 1898), which would retroactively repeal the individual mandate for health insurance. Press release: http://bit.ly/2fxAkZF Bill text: http://bit.ly/2fxAKzd
  • Also on September 28, Sens. Cassidy (R-LA) and Graham (R-SC) released a joint statement noting that they intend to continue the debate about health care reform and that “over the coming weeks and months, we are committed to holding congressional hearings and working with our nations’ governors who believe returning power to states is a vast improvement over Obamacare.” Statement: http://bit.ly/2xKnT52

ACA Implementation –

  • On September 26, CMS released an enforcement safe harbor for renewal notices in connection with the 2018 open enrollment period for non-grandfathered coverage. Notice: http://go.cms.gov/2wUUqDL
  • On September 27, Sens. Schatz (D-HI), Warren (D-MA), Booker (D-NJ), and Murphy (D-CT) sent a letter to HHS Inspector General Levinson and CMS Administrator Verma expressing concern regarding reports that CMS will temporarily shut down Healthcare.gov for extended periods during the upcoming open enrollment period. Press release: http://bit.ly/2xGf7GY Letters: http://bit.ly/2xHjIZz and http://bit.ly/2xGKCR2
  • On September 28, CMS announced a new special enrollment period for individuals affected by Hurricanes Harvey, Irma, or Maria, allowing them to make changes to their existing 2017 qualified health plan enrollment through the federally-facilitated exchange at any time through December 31, 2017. Press release: http://go.cms.gov/2xLeA6A Guidance: http://go.cms.gov/2xLxyKs
  • Also on September 28, HHS Office of the Inspector General (OIG) released a report finding that CMS did not provide effective oversight to ensure that state-based marketplaces always properly determined individuals’ eligibility for qualified health plans and insurance affordability programs. Summary with link to report: http://bit.ly/2xKZ4pN
  • On September 29, Oklahoma Secretary of Health and Human Services sent a letter to HHS Secretary Price and Treasury Secretary Mnuchin withdrawing its 1332 waiver, arguing that the Administration did not approve its proposal in time to help with 2018 individual market premiums. Letter: http://bit.ly/2xMffor
  • Also on September 29, Ranking Members from the Senate HELP, Finance, and Aging Committees, and House Energy & Commerce and Ways & Means Committees sent a letter to HHS Secretary Price urging him to immediately reverse the decision barring the Department’s 10 Regional Offices from appearing at Marketplace Open Enrollment events. Press release: http://bit.ly/2fy5W1j Letter: http://bit.ly/2fyKgCs
  • Also on September 29, Rep. Engel (D-NY) led a group of 221 bipartisan House members in a letter to House Speaker Ryan (R-WI) and Minority Leader Pelosi (D-CA) calling for an immediate delay to Medicaid Disproportionate Share Hospital payment cuts. Press release: http://bit.ly/2fxyvMj Letter: http://bit.ly/2fxyqrZ

Medicare –

  • On September 27, OIG released a report finding that enhancements are needed in the tracking and collection of Medicare overpayments identified by zone program integrity contractors and program safeguard contractors. Summary with link to report: http://bit.ly/2xKZ5Kb
  • On September 28, OIG released a report finding that overall, states received one-third more nursing home complaints in 2015 than in 2011, however, a few states fell short in timely investigation of the most serious complaints. Summary with link to report: http://bit.ly/2xKjxuI
  • On September 29, CMS released data on enrollment, premiums and costs for 2018 Medicare Parts C and D plans. Press release: http://go.cms.gov/2xLpMP2 Fact sheet: http://go.cms.gov/2xKVU5d Data: http://go.cms.gov/2d6ts4j
  • Also on September 29, U.S. Government Accountability Office (GAO) released a report describing CMS’ use of claims analyses through its Fraud Prevention System to address potential fraud in the Medicare program. Summary with link to report: http://bit.ly/2xLhW89


  • On September 27, Senate Homeland Security and Governmental Affairs Committee Chair Johnson (R-WI) sent letters to CMS Administrator Verma and the governors of eight states asking for information related to Medicaid expansion and “the soaring costs that go far beyond initial projections.” Press release: http://bit.ly/2xJAuqT
  • On September 29, CMS announced an update for the federal upper limits, which are calculated in accordance with the Medicaid Covered Drug Outpatient Drug final rule. Updated FUL: http://bit.ly/2xMflwj

New Payment and Delivery System Models –

  • On September 26, CMS released a frequently asked questions (FAQ) document for the Beneficiary Engagement and Incentives Shared Decision Making Model. FAQ: http://bit.ly/2wUELEn
  • On September 28, CMS released an updated list of skilled nursing facilities participating in the Comprehensive Care for Joint Replacement Model. List: http://bit.ly/2xLyhLs
  • On September 29, CMS released an updated list of Bundled Payments for Care Improvement awardees eligible for a three-day hospital stay waiver. Updated list: http://bit.ly/2cT8ngl

 Mental Health and Substance Abuse –

  • On September 27, HHS Office of Minority Health announced the award of $5 million in new cooperative agreements to 15 organizations to address the opioid crisis, childhood obesity, and serious mental illness. Press release: http://bit.ly/2xGZ4Zy
  • Also on September 27, Sen. Manchin (D-WV) sent a letter to two health insurers imploring them to make less addictive, alternative pain management drugs and physical therapy readily available and affordable immediately, while also increasing coverage of substance abuse treatment. Press release: http://bit.ly/2fwCmtg
  • On September 28, Food and Drug Administration (FDA) released a request for comments relevant to the FDA’s newly established Opioid Policy Steering Committee. Comments are due by December 28. Notice: http://bit.ly/2fyEMaQ
  • Also on September 28, Food and Drug Administration (FDA) Commissioner Gottlieb penned a blog post highlighting some of the steps the FDA has taken, or plans to take, to stem the tide of opioid misuse and abuse. Blog post: http://bit.ly/2xSfxtT
  • Also on September 28, HHS released a series of reports on prolonged youth homelessness, including the factors causing prolonged homelessness, the relationship between serious mental illness and prolonged youth homelessness and interventions to address youth homelessness. Reports: http://bit.ly/2xLjrmA and http://bit.ly/2xLZVq6 and http://bit.ly/2xNhsOK

 Prescription Drugs –

  • On September 25, FDA announced that it recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines to American consumers. Press release: http://bit.ly/2wViOoC
  • On September 28, HHS released a final rule delaying the effective date of the 340B Drug Pricing Program to July 1, 2018. Final rule: http://bit.ly/2fyD09G
  • Also on September 28, Rep. Thompson (D-CA) led a group of 228 bipartisan members of Congress in a letter to CMS Administrator Verma urging the Administration to withdraw its proposal to levy cuts on certain hospitals participating in the 340B Drug Pricing Program as part of its Outpatient Prospective Payment System proposed rule for 2018. Press release: http://bit.ly/2fxwwI2 Letter: http://bit.ly/2fzly4W

Veterans Health –

  • On September 25, Senate Veterans Affairs Committee Ranking Member Tester (D-MT), and Sens. Murray (D-WA), Sanders (I-VT), Brown (D-OH), and Manchin (D-WV) sent a letter to VA Secretary Shulkin urging him to expand the agency’s list of medical conditions association with exposure to Agent Orange. Press release: http://bit.ly/2wVf9af Letter: http://bit.ly/2wUzAEs
  • On September 29, GAO released a report finding that the VA should improve the information it publicly reports on the quality of care at its medical facilities. Summary with link to report: http://bit.ly/2xKkEdT
  • Also on September 29, VA released a proposed rule that would give greater flexibility for VA health care providers to practice telehealth, irrespective of State, or location in a State of the VA healthcare provider or the beneficiary. Comments are due by November 1. Proposed rule: http://bit.ly/2xLrSyo

 Health IT –

  • On September 26, Food and Drug Administration (FDA) announced the names of nine companies selected to participate in a recertification pilot program intended to inform a tailored approach to digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product. Press release: http://bit.ly/2xGqmiE
  • Also on September 26, HHS announced two prize competitions to support the development and testing of low-cost, scalable technology-based innovations. The first is intended for products that improve the ability of prenatal providers to monitor the health and wellbeing of pregnant women remotely. The second is intended for products that promote healthy weight for low-income children and families. Submissions are due by January 31. Notices: http://bit.ly/2fyc7CN and http://bit.ly/2fzmZQE
  • On September 28, FDA released a request for nominations for the Public Advisory Panel of the Medical Devices Advisory Committee. Nominations are due by October 30. Notice: http://bit.ly/2fwEyRw
  • On September 29, FDA released guidance for industry on the advancement of emerging technology applications for pharmaceutical innovation and modernization. Guidance: http://bit.ly/2xL1mVV

 Hurricanes –

  • On September 25, Food and Drug Administration (FDA) Commissioner Gottlieb released a statement on FDA actions to bring relief to the citizens of Puerto Rico, to help the island recover its medical product manufacturing base, and to prevent critical shortages of drugs made in Puerto Rico. Statement: http://bit.ly/2fymeaM
  • On September 30, HHS announced additional efforts to augment medical care at hospitals in Puerto Rico impacted by Hurricane Maria. Press release: http://bit.ly/2xKtsQV

HHS Secretary Price Travel –

  • On September 26, House Appropriations Committee Ranking Member Lowey (D-NY) and Subcommittee on Labor, Health and Human Services, and Education Ranking Member DeLauro (D-CT) sent a letter to HHS Secretary Price requesting specific details regarding his reported dozens of flights on private charter planes at taxpayers’ expense. Press release with text of letter: http://bit.ly/2xGZPls
  • On September 27, House Oversight and Government Reform Committee Chair Gowdy (R-SC) and Ranking Member Cummings (D-MD) sent letters to the White House and 24 federal agencies requesting information related to senior officials’ use of government-owned aircraft or private non-commercial aircraft for official and personal travel. Press release: http://bit.ly/2xGYJpS Letter: http://bit.ly/2xGCT5z
  • On September 28, Senate HELP Committee Ranking Member Murray (D-WA), Senate Finance Committee Ranking Member Wyden (D-OR), and seven Democrats sent a letter to HHS Secretary Price requesting he provide detailed information on the purpose of each private jet trip he has taken and any communications between his office and the White House regarding his travel plans. Press release: http://bit.ly/2xLDTWl Letter: http://bit.ly/2xLugqA
  • Also on September 28, HHS Secretary Price released a statement announcing his full cooperation with the Office of the Inspector General and his intention to write a personal check for the expenses of his travel on private charter planes. Press release: http://bit.ly/2xLHfsp
  • Also on September 28, Senate Judiciary Committee Chair Grassley (R-IA) sent a letter to President Trump urging him to curb cabinet secretaries’ expensive travel amid recent reports of the use of charter flights. Press release: http://bit.ly/2fwE6mi Letter: http://bit.ly/2fyV9E2

 Misc. –

  • On September 26, HHS released a draft strategic plan for fiscal years 2018-2022, which is intended to describe the agency’s work to address the complex and evolving health and human services under its purview. It describes the agency’s mission, goals, and the means by which it will measure its progress over the four-year period. Comments are due by October 27. Strategic plan: http://bit.ly/2wUVUh7
  • Also on September 26, HHS announced a three-year $8.1 million contract with the Biomedical Advanced Research and Development Authority (BARDA) to develop a point-of-care diagnostic test that may be able to determine within 15 minutes whether a patient has been infected with the bacterium that causes anthrax. Press release: http://bit.ly/2wUTE9P
  • Also on September 26, U.S. Preventive Services Task Force (USPSTF) issued a draft recommendation on prevention of falls and fractures, finding that exercise can help prevent falls and that risk assessments and tailored interventions may be beneficial to some older adults. Comments are due by October 23. Draft recommendation: http://bit.ly/2xGdMzQ
  • Also on September 26, FDA released a statement on new efforts to encourage compounding of better quality drugs under the Drug Quality and Security Act and help health care professionals access compounded medications needed for patient care from outsourcing facilities. Statement: http://bit.ly/2xGZlM6
  • Also on September 26, FDA released final guidance providing the agency’s current thinking on approaches for classifying products as drugs and devices and on certain additional product classification issues. Guidance: http://bit.ly/2fw98ug