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

 Administration –

  • On November 13, President Trump announced the nomination of Alex M. Azar to serve as HHS Secretary. Mr. Azar previously served as HHS Deputy Secretary from 2005-2007, and as HHS General Counsel from 2001-2005. The Senate Finance and HELP Committees will consider his nomination; a HELP Committee hearing has been scheduled for November 29. White House Press release: http://bit.ly/2zJ1giz Finance Committee Press releases: http://bit.ly/2zIp5Ha and http://bit.ly/2zINEDO HELP Committee Press releases: http://bit.ly/2zITVzw and http://bit.ly/2zLyxK9

 Tax Reform –

  • On November 16, the House passed by a vote of 225-207 the Tax Cuts and Jobs Act (H.R. 1), which will reform the federal tax code. The same day, the Senate version of the bill, which includes a repeal of the individual mandate passed out of the Senate Finance Committee by a vote of 14-12. It now moves to the full Senate for consideration. Press releases: http://bit.ly/2zbwMIU and http://bit.ly/2zbviyx. Summaries: http://bit.ly/2zbzzSo and http://bit.ly/2iZ0MwW

 Legislative Activity –

  • On November 13, Sens. Durbin (D-IL), Blumenthal (D-CT), Markey (D-MA), Reed (D-RI), Brown (D-OH), Wyden (D-OR), and Murray (D-WA) introduced S. 2119, which would prohibit smoking in any facility of the Veterans Health Administration. Press release: http://bit.ly/2iXhAUP
  • On November 14, Sens. Shaheen (D-NH), Hassan (D-NH), Manchin (D-WV), and Capito (R-WV) introduced S. 2125, which would improve the state response to the opioid abuse crisis by revising the funding formula used to distribute grants to states. Press release: http://bit.ly/2zLeI5l
  • On November 15, the Senate unanimously passed the VA Prescription Data Accountability Act (S. 1567), which would clarify the authority of the Secretary of Veterans Affairs to disclose certain patient information to the state controlled substance monitoring programs. Having previously passed the House, the bill now moves to the President for signature. Press release: http://bit.ly/2zNFAV0
  • Also on November 15, House Ways & Means Committee Chair Brady (R-TX) and Ranking Member Neal (D-MA) announced a bipartisan agreement relating to Medicare extenders, including the Medicare Dependent Hospital Program, the Home Health rural add-one, among others. Press release: http://bit.ly/2zMbZLC
  • Also on November 15, Rep. Emmer (D-MN) and three cosponsors introduced the State CHIP Flexibility Act (H.R. 4404), which would provide for an exception to the reduction to state allotments under the Children’s Health Insurance Program for fiscal year 2018. Press release: http://bit.ly/2zL0DHD Bill text: http://bit.ly/2zLUDyk
  • Also on November 15, Sens. Baldwin (D-WI), Capito (R-WV), Moran (R-KS), Manchin (D-WV), Blumenthal (D-CT), and Tester (D-MT) introduced the Andrew White Veterans Community Care Opioid Safety Act, which would require the Secretary of Veterans Affairs to establish processes to ensure that non-Department of Veterans Affairs health care providers are using safe practices in prescribing opioids to veterans under the laws administered by the Secretary. Press release: http://bit.ly/2zLVvD6
  • On November 16, Senate HELP Committee Ranking Member Murray (D-WA) and Senate Veterans Affairs Committee Ranking Member Tester (D-MT) introduced the VA Newborn Emergency Treatment Act (S. 2131), which would authorize the Secretary of Veterans Affairs to furnish medically necessary transportation for newborn children of certain women veterans. Press release: http://bit.ly/2zJQJWO
  • Also on November 16, Sen. Udall (D-NM) and seven cosponsors introduced the Urban Indian Health Parity Act, which would extend the full federal medical assistance percentage to urban Indian organizations (S. 2156). Rep. Lujan (D-NM) introduced companion legislation in the House (H.R. 4443). Press release: http://bit.ly/2zRU2e1

 ACA Market Stabilization & Implementation –

  • On November 14, the Federal Trade Commission posted a warning to consumers on avoiding open enrollment scams either for the ACA’s marketplaces or for Medicare. Post: http://bit.ly/2zJC7nM
  • On November 15, CMS released data showing that 876,788 consumers enrolled in coverage using Healthcare.gov in the second week of Open Enrollment, including 208,397 new consumers. Press release: http://go.cms.gov/2iWLnx2

Medicare –

Medicaid and CHIP

  • On November 14, CMS released an informational bulletin describing the 2018 updates to the core set of children’s health care quality measures for Medicaid and the Children’s Health Insurance Program and the core set of health care quality measures for adults enrolled in Medicaid. Bulletin: http://bit.ly/2zIPNzm
  • On November 16, CMS released an informational bulletin on implementation approaches for the Medicaid access to care fee for service requirements. Bulletin: http://bit.ly/2mzK4Jz

New Payment and Delivery System Models –

  • On November 13, Sens. Collins (R-ME) and King (I-ME) led a bipartisan group of 30 senators in a letter to U.S. Attorney General Sessions asking him to provide Congress with information detailing how the Department of Justice is supporting and prioritizing forensic science service providers across the nation as a part of a broader approach to combat the opioid epidemic. Press release: http://bit.ly/2zKlCYN Letter: http://bit.ly/2zKq09W
  • On November 14, CMS announced the cancellation of the Beneficiary Engagement and Incentives Shared Decision Making Model due to insufficient interest from ACOs. Announcement: http://bit.ly/2gpg9i2

 Mental Health and Substance Abuse –

  • On November 15, FDA granted a new indication to an electronic stimulation device for use in helping to reduce the symptoms of opioid withdrawal. Press release: http://bit.ly/2zLK52a
  • On November 16, National Institutes of Health (NIH) announced that scientists have discovered a way to minimize the risk of respiratory failure from pain medications. Press release: http://bit.ly/2zJzS6x

 Prescription Drugs –

  • On November 13, U.S. Government Accountability Office (GAO) released a report finding that despite expanded efforts to collect unused prescription drugs for disposal, only about three percent of pharmacies and other entities eligibility to do so have volunteered. Summary with link to report: http://bit.ly/2iUTN80
  • On November 16, FDA announced a new comprehensive regenerative medicine policy framework, which describes what products are regulations as drugs, devices, and/or biological products. Press release: http://bit.ly/2zJp9ZP FDA Commissioner Gottlieb Statement: http://bit.ly/2zLKHVM

 Health IT –

  • On November 14, GAO released a report reviewing the Department of Defense’s (DOD) use of telehealth, finding that DOD provided about 59,000 telehealth service encounters between provider and patients or between two providers in 2016. Summary with link to report: http://bit.ly/2iWwECh
  • On November 15, House Energy & Commerce Committee Chair Walden (R-OR), Ranking Member Pallone (D-NJ), and Subcommittee on Oversight and Investigations DeGette (D-CO) sent a letter to HHS Acting Secretary Hargan requesting information about whether recent actions by the Department could potentially weaken the HHS role in responding, or assisting stakeholder responses, to cybersecurity incidents affecting the healthcare sector in the U.S. Letter: http://bit.ly/2zKaYkP
  • Also on November 15, House Energy & Commerce Committee Chair Walden (R-OR) sent a letter to HHS Acting Secretary Hargan requesting the Department convene a sector-wide effort to establish a plan of action for creating, deploying, and leverage software bill of materials for healthcare technologies. Press release: http://bit.ly/2zLzMLB Letter: http://bit.ly/2zLKlhW
  • On November 16, HHS released a patient safety primer on electronic health records, which summarizes the “positive health effects that electronic health records can have on patient safety and the unintended patient safety concerns they can create.” Summary with link to report: http://bit.ly/2zSGCyH
  • On November 17, HHS announced the members of the new Health IT Advisory Committee, which was created by the 21st Century Cures Act and is charged with making recommendations to the National Coordinator for Health IT relating to the implementation of national and local health IT infrastructure. Press release: http://bit.ly/2mC3nSk
  • Also on November 17, FDA released guidance clarifying when direct marking of devices with a unique device identifier is required. Notice: http://bit.ly/2zLXB5U Guidance: http://bit.ly/2zMkyGg

 Misc. –

  • On November 14, House Energy & Commerce Committee Chair Walden (R-OR) sent a letter to the National Institutes of Health regarding NIH-sponsored emergency medical research that is conducted without informed consent. Press release: http://bit.ly/2zJoWTX Letter: http://bit.ly/2zJp3il
  • On November 15, HHS Office of Inspector General released a list of the top ten management and performance challenges facing HHS, including program integrity, curbing the opioid epidemic, and protecting against cybersecurity threats. List: http://bit.ly/2mC4qSg
  • On November 16, Centers for Disease Control and Prevention (CDC) released health insurance coverage estimates for the first half of 2017, finding that 9.0 percent of persons of all ages were uninsured at the time of interview, which is not significantly different than 2016. Report: http://bit.ly/2zLr00b
  • Also on November 16, HHS released a chart book on rural health care, which finds that the quality of care for those living in rural areas improved for 53 percent of the measures studied. Summary with link to report: http://bit.ly/2zSSH6S
  • Also on November 16, HHS released data finding that in 2014, acute renal failure was in the top 20 most frequent primary reasons for hospitalization. Summary with link to report: http://bit.ly/2zSH2Fh
  • On November 17, CDC released a report highlighting innovations and opportunities for improving medication adherence for chronic disease management. Report: http://bit.ly/2mCkzqJ
  • Also on November 17, CDC released a report finding that fewer than one in ten Americans eat the recommended amount of fruit and vegetables daily, a rate which varies by state. Report: http://bit.ly/2mAv3Hf
  • Also on November 17, CDC released a report on racial and ethnic disparities among rural adults, finding that more racial/ethnic minorities reported their health as either fair or poor than non-Hispanic whites. Report: http://bit.ly/2zbbwmH