What’s Ahead: This Week

Notable Policy Events –

• Tuesday, April 18
  • Federal Trade Commission, “Now Hear This: Competition, Innovation, and Consumer Protection Issues in Hearing Health Care.” Additional information: http://bit.ly/2owr9y9
  • Health Affairs, “Securing the Future of Value-Based Payment.” Additional information: http://bit.ly/2owhqrs
  • Bipartisan Policy Center (BPC), “Evaluating Patient Treatment Options: How Do We Know What Works Best?” Additional information: http://bit.ly/2owkzYp
• Wednesday, April 19
  • The Atlantic, “The Future of Prescription Drugs: Assessing Value.” Additional information: http://theatln.tc/2ownVL5
• Thursday, April 20 – Friday, April 21
  • Medicaid and CHIP Payment and Access Commission (MACPAC), “April Public Meeting.” Additional information: http://bit.ly/2offpg4

Weekly Wrap Up: Notable Health Care Developments From Last Week

Congressional Schedule –

• Congress is currently in recess, and will return the week of April 24.

Legislative Activity –

• On April 13, Sens. Gillibrand (D-NY) and McCain (R-AZ) announced the Opioid Addiction Prevention Act of 2017, which would establish additional registration requirements for prescribers of opioids. Press release: http://bit.ly/2ognVfB Bill text: http://bit.ly/2ogrGl5
• On April 14, Senate HELP Committee and House Energy & Commerce Committee released a discussion draft of the Food and Drug Administration (FDA) Reauthorization Act of 2017, which renews FDA’s authority to collect user fees from the makers of prescription brand drugs, medical devices, generic drugs and biosimilar. Press release: http://bit.ly/2oHNDge One-pager: http://bit.ly/2oHQ7Lq Section-by-section: http://bit.ly/2oHXVgn Discussion draft: http://bit.ly/2oHPeCn

 Administration –

• On April 10, House Energy & Commerce Committee Ranking Member Pallone (D-NJ) sent letters to the Inspectors General of the Environmental Protection Agency, Department of Health & Human Services, Department of Energy, Department of Commerce, and the Nuclear Regulatory Commission requesting information on the impact of the Trump Administration’s proposed budget cuts to their agencies. Press release: http://bit.ly/2owb2Rh Letter: http://bit.ly/2owddnR
• On April 12, the White House issued a memorandum announcing a long-term plan to reduce the size of the federal government, which would replace an agency-wide hiring freeze issued in late January. The plan requires immediate administrative actions to for near-term workforce reductions and cost savings and to maximize employee performance. Memoranda: http://bit.ly/2ow73nK

 ACA Repeal and Replace Activity –

• On April 13, Sen. Tester (D-MT) sent a letter to President Trump highlighting the need for a bipartisan health care solution that lowers premiums, limits out-of-pocket expenses for rural families, and expands access to health insurance. Press release: http://bit.ly/2oHQSE3 Letter: http://bit.ly/2oHRM3C

 ACA Implementation –

• On April 13, CMS released a final rule intended to help stabilize the ACA’s marketplaces through a shorter open enrollment period in 2017, pre-enrollment verification of eligibility for special enrollment periods, and additional actuarial flexibility in plan design, among others. In conjunction with the final rule, CMS also updated a number of QHP certification guidance documents.
• Press release: http://go.cms.gov/2ox1NAb Final Rule: http://bit.ly/2owN1t9
• QHP Certification Guidance – Key dates: http://go.cms.gov/2ogjvoV Uniform Rate Review: http://go.cms.gov/2ogpZ7q Good Faith Compliance: http://go.cms.gov/2ogrbHJ QHP Certification: http://go.cms.gov/2ogmAp4 Final Actuarial Value Calculator for 2018: http://bit.ly/2ogp6M5

Medicare –

• On April 10, U.S. Government Accountability Office (GAO) released a report finding that greater oversight of Medicare provider education efforts is needed in order to reduce improper billing. Summary with link to report: http://bit.ly/2owDYIT
• On April 11, CMS posted its annual release of the Geographic Variation Public Use file, which includes 2015 data on geographic variation in the Medicare program. Data: http://go.cms.gov/2owmWKO
• On April 13, CMS released a pair of reports detailing the quality of care received by people enrolled in Medicare Advantage (MA), which find racial, ethnic and gender differences in treatment among beneficiaries. Press release: http://go.cms.gov/2owgWSh Reports: http://go.cms.gov/2ow9CWS and http://go.cms.gov/2owh0S1
• On April 14, CMS released proposed fiscal year 2018 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Acute Care Hospital (LTCH) Prospective Payment System rules, and a request for information on ideas to improve the health care delivery system and reduce burden. Comments are due by June 13. Press release: http://go.cms.gov/2ogdJ6D Fact sheet: http://go.cms.gov/2ogukHy Proposed rule: http://bit.ly/2ogni5O

 New Payment and Delivery Models –

• On April 12, CMS released a notice announcing the issuance of a single-source cooperative agreement funding opportunity announcement to begin implementation activities for the Pennsylvania Rural Health Model. Notice: http://bit.ly/2own1yg

 Health IT –

• On April 12, HHS announced a Health Insurance Portability and Accountability Act of 1996 (HIPAA) settlement based on the lack of a security management process to safeguard electronic protected health information. Press release: http://bit.ly/2owsDs3
• On April 14, GAO released a report reviewing the current use of telehealth and remote patient monitoring in Medicare and selected federal programs, finding that utilization in Medicare may change depending on how many clinicians use the tools as a way to achieve the goals of the new Merit-based Incentive Payment System. Summary with link to report: http://bit.ly/2oHVSsw

 Veterans Health –

• On April 12, Department of Veterans Affairs (VA) launched a new Access and Quality Tool that provides Veterans with access to patient wait time and quality of care data at VA facilities across the country. Press release: http://bit.ly/2owFwlP Tool: http://bit.ly/2owZMUD
• Also on April 12, VA Office of Inspector General (VA-OIG) released an interim summary report finding inventory management and staffing deficiencies at the Washington, D.C. VA Medical Center that place patients at unnecessary risk. Press release: http://bit.ly/2owOJdV Report: http://bit.ly/2owCFJC
• On April 13, Sens. Tester (D-MT) and Murray (D-WA) sent a letter to VA Secretary Shulkin urging him to investigate why some hospitals across the country are removing caregivers from a support program that is critical for veterans and their families. Press release: http://bit.ly/2oHNqtl Letter: http://bit.ly/2oHS5eM
• On April 14, Senate Veterans Affairs Committee Chair Isakson (R-GA) and Sens. Tester (D-MT), Klobuchar (D-MN) and Blumenthal (D-CT) sent a letter to VA Secretary Shulkin, urging him to identify why the VA has been slow to improve the Veterans’ Crisis Line, noting that “it’s critical that the VA deliver on its promises to improve the performance of the Crisis Hotline.” Press release: http://bit.ly/2oHQx4e

 Zika and Ebola –

• On April 10, Rep. Buchanan (R-FL) led a group of 20 bipartisan members in a letter to House Appropriations Committee, Subcommittee on Labor, Health & Human Services, Education and Related Agencies Cole (R-OK) and Ranking Member DeLauro (D-CT) urging them to establish a rapid-response fund to combat deadly infectious diseases such as Zika and Ebola that threaten public health. Press release: http://bit.ly/2owmJqU Letter: http://bit.ly/2owpY1L
• On April 12, HHS announced an $8.9 million agreement with Siemens Healthineers to further develop a Zika virus test that could expand the nation’s testing capacity for the virus. Press release: http://bit.ly/2owk2Wl
• Also on April 12, Centers for Disease Control and Prevention (CDC) released a set of guidelines and resources for protecting pregnant women and babies from being infected with the Zika virus. Guidance: http://bit.ly/2owACp3
• Also on April 12, National Academy of Medicine released a report examining lessons learned from the Ebola response and how to more quickly respond to a disease epidemic in the future. Link to download report: http://bit.ly/2owmFHy

 Misc. –

• On April 11, U.S. Preventive Services Task Force (USPSTF) released a draft recommendation advising against prostate screening for men 70 years of age and older. Comments are due by May 8. Draft recommendation: http://bit.ly/2owbqPE
• On April 13, CDC released updated life tables for 2013, which find that the overall expectation of life at birth on average was 78.8 years. Report: http://bit.ly/2pyOuwS
• On April 13, FDA released a notice identifying a list of class I devices that are now exempt from premarket notification requirements. Notice: http://bit.ly/2owuuNs
• On April 13, HHS released a report finding that about a quarter of persons who visited their usual source of care practice in 2015 used a practice with only one physician. Report: http://bit.ly/2oHO5eh
• On April 13, National Institutes of Health released a report finding that rates of new diagnosed cases of type 1 and type 2 diabetes is on the rise among children and teenagers. Press release: http://bit.ly/2oHPG3F Report: http://bit.ly/2oHIlB4
• On April 14, CDC released a report finding that approximately two-thirds of investigated opioid overdose deaths in southeastern Massachusetts during October 1, 2014 through March 31, 2015 involved fentanyl. Report: http://bit.ly/2oHOMUG