What’s Ahead: This Week

Notable Policy Events –

  • Monday, March 26 – Tuesday, March 27
    • Physician-Focused Payment Model Technical Advisory Committee (PTAC), “March Public Meeting.” Additional information: http://bit.ly/2ISx5tA
  • Wednesday, March 28
    • National Virginia Health Policy Forum, “A Panel on the Opioid Epidemic: the Exchange of Health Information and the Pharmacist’s Perspective.” Additional information: http://bit.ly/2IIB3Vj

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

Appropriations –

  • On March 23, President Trump signed into law H.R. 1625, an omnibus bill that authorizes funding for the federal government through the remainder of fiscal year 2018. Previously, the House passed the bill by a vote of 256-167, and the Senate passed the bill by a vote of 65-32. The bill increases discretionary funding for HHS by $10 billion and appropriates $4 billion across several federal agencies to fight the opioid epidemic. Press releases: http://bit.ly/2IJXutb and http://bit.ly/2uefKrE HHS summary: http://bit.ly/2IHG1le Opioids Summary: http://bit.ly/2IO4mpH Text: http://bit.ly/2IRETeZ

Legislative Activity –

  • On March 19, Rep. DeSaulnier (D-CA) introduced the Affordable Health Insurance for the Middle Class Act (H.R. 5258), which would expand eligibility to receive refundable tax credits for coverage under a qualified health plan. Sen. Feinstein (D-CA) previously introduced companion legislation (S. 1307). Press release: http://bit.ly/2FQGTpX
  • Also on March 19, Rep. Ferguson (R-GA) introduced the Supporting Teachers and Safe Students Act (H.R. 5324), which would improve school safety and mental health services. Press release: http://bit.ly/2FSFwXK
  • Also on March 19, House Energy & Commerce Committee Subcommittee on Health Chair Guthrie (R-KY), Ranking Member Green (D-TX), and Reps. Lujan (D-NM) and Bucshon (R-IN) introduced the Comprehensive Opioid Recovery Centers Act of 2018 (H.R. 5327), which would amend title V of the Public Health Service Act to establish a grant program to create comprehensive opioid recovery centers. Sens. Hassan (D-NH) and Capito (R-WV) introduced companion legislation in the Senate (S. 2589). Press releases: http://bit.ly/2FR58Ev and http://bit.ly/2IKNVKR
  • Also on March 19, Reps. Brooks (R-IN), Engel (D-NY), Barton (R-TX), and DeGette (D-CO) introduced the Poison Center Network Enhancement Act of 2018 (H.R. 5329), which would reauthorize and enhance the poison center national toll-free number, national media campaign, and grant program. Press release: http://bit.ly/2IMR5gR
  • Also on March 19, Rep. Latta (R-OH) and five bipartisan cosponsors introduced the Over-the-Counter Monograph Safety, Innovation, and Reform Act (H.R. 5333), which would amend the Food Drug and Cosmetic Act to clarify the regulatory framework with respect to certain non-prescription drugs that are marketed without an approved new drug application. Press release: http://bit.ly/2FPAISU
  • On March 20, Reps. Carter (R-GA) led a group of five bipartisan cosponsors in introducing the Prescription Transparency Act (H.R. 5343), which would nullify certain contractual provision prohibiting or penalizing a pharmacists disclosure of the availability of therapeutically alternative drugs, or other methods of purchasing the prescription drug. Press release: http://bit.ly/2FTINpS
  • Also on March 20, Reps. Lance (R-NJ) and Kennedy (D-MA) introduced the Eliminating Opioid-Related Infectious Diseases Act (H.R. 5353), which would reauthorize and expand a program of surveillance and education, carried out by the Centers for Disease Control and Prevention, regarding infections associated with injection drug use. Sens. Young (R-IN), Markey (D-MA), and Baldwin (D-WI) introduced companion legislation in the Senate (S. 2579). Press releases: http://bit.ly/2IN43LM and http://bit.ly/2IN4c1M
  • On March 21, the House passed by a vote of 267-149 the Trickett Wendler, Frank Mongiello, Jordan McClinn, and Matthew Bellina Right to Try Act of 2018 (H.R. 5247), which would make it easier for terminally ill patients to access experimental treatments not yet approved by the Food and Drug Administration. The Senate failed to approve the measure, in a vote on March 22, but has previously passed a similar version of the bill (S. 204). Press release: http://bit.ly/2ufCh7h
  • Also on March 21, Sens. Warren (D-MA), Hassan (D-NH), Sanders (I-VT), Harris (D-CA), Baldwin (D-WI) and Gillibrand (D-NY) introduced the Consumer Health Insurance Protection Act (S. 2582), which would limit insurer profits and unreasonable premium increases and enhance insurance affordability programs. Press release: http://bit.ly/2IGWRAK Summary: http://bit.ly/2GcP3s6  Bill text: http://bit.ly/2IKluN8
  • On March 22, House Committee on Energy & Commerce, Subcommittee on Health Chair Burgess (R-TX), Ranking Member Green (D-TX), and Rep. DeLauro (D-CT) introduced H.R. 5385, which would reauthorize the program of payments to children’s hospitals that operate graduate medical education programs. Sens. Casey (D-PA) and Isakson (R-GA) introduced companion legislation in the Senate (S. 2597). Press release: http://bit.ly/2ISDcOf
  • Also on March 22, Sens. Young (R-IN), Markey (D-MA), and Baldwin (D-WI) introduced the Eliminating Opioid-Related Infectious Diseases Act of 2018 (S. 2579), which would expand a program of surveillance and education, carried out by the Centers for Disease Control and Prevention, regarding infections associated with injection drug use. Press release: http://bit.ly/2IN4c1M
  • Also on March 22, Sens. Warren (D-MA) and Capito (R-WV) introduced the Reducing Opioids Risk Act (S. 2608), which would provide that a risk evaluation and mitigation strategy communication plan may include information about federal and state prescribing requirements for controlled substances. Press release: http://bit.ly/2IM5QAH Summary: http://bit.ly/2IM6f6b Bill text: http://bit.ly/2IMalex
  • Also on March 22, Sens. Murphy (D-CT) and Capito (R-WV) introduced two pieces of legislation, the Recovery COACH Act (S. 2609) would provide grants for state alcohol and drug agencies to use recovery coaches in hospital emergency departments, and the Preventing Overdoses While in Emergency Departments Act (S. 2610), would require the Secretary of Health and Human Services to provide coordinated care to patients who have experiences a non-fatal overdose after emergency department discharge. Press release: http://bit.ly/2IO69ec Summaries: http://bit.ly/2IOjfZ2 and http://bit.ly/2IOxFrU
  • Also on March 22, Sens. Smith (D-MN) and Young (R-IN) introduced the One Health Act (S. 2615), which would establish an interagency One Health Program to prepare for and prevent health crises like the 2015 avian flu outbreak. Press release: http://bit.ly/2INFVIN

ACA Stabilization –

  • On March 19, Senate HELP Committee Chair Alexander (R-TN), Sen. Collins (R-ME), House Energy & Commerce Committee Chair Walden (R-OR) and Rep. Costello (R-PA) introduced the Bipartisan Health Care Stabilization Act, a draft bill that would stabilize individual market premiums and provide state flexibility by revising the rules related to section 1332 waivers, and providing funding for reinsurance programs and cost-sharing reduction payments. Press release: http://bit.ly/2HQQ1HI Proposed bill text: http://bit.ly/2pquRsX
  • Also on March 19, Congressional Budget Office released an analysis finding that the Bipartisan Health Care Stabilization Act would decrease premiums by 10 percent on average in 2019. Senate HELP Committee Chair Alexander Press release: http://bit.ly/2HTzoLr CBO analysis: http://bit.ly/2DJERSB

Medicare –

  • On March 20, Senate Finance Committee Chair Hatch (R-UT) led a group of eight senators in a letter to CMS Administrator Verma providing comment on the agency’s calendar year 2019 proposals for Medicare Advantage (MA) and expressing support for the recent expansion of MA supplemental benefits. Press release: http://bit.ly/2HTZa2h Letter: http://bit.ly/2HTW0vn

Medicaid –

  • On March 22, CMS release a notice of proposed rulemaking that would provide state flexibility from certain regulatory access to care requirements within the Medicaid program. Comments are due by May 22. Press release: http://go.cms.gov/2ILm7FW Proposed rule: http://bit.ly/2IMaq1N
  • Also on March 22, CMS released a final notice announcing changes to the Medicaid National Drug Rebate agreement to incorporate legislative and regulatory changes, including the 2016 Covered Outpatient Drug final rule. Notice: http://bit.ly/2IKk6Kq
  • On March 22, Senate Finance Committee Chair Hatch (R-UT), Ranking Member Wyden (D-OR), Sens. Grassley (R-IA) and McCaskill (D-MO), House Energy & Commerce COmmittee Chair Walden (R-OR), Ranking Member Pallone (D-NJ), Health Subcommittee Chair Burgess (R-TX), Ranking Member Green (D-TX), Oversight and Investigations Subcommittee Chair Harper (R-MS), and Ranking Member DeGette (D-CO) sent a letter to CMS regarding its oversight of the Medicaid drug rebate program. Press release: http://bit.ly/2IMUIUj Letter: http://bit.ly/2IP3XDs

New Payment and Delivery System Models –

  • On March 20, Sens. Cassidy (R-LA) and Whitehouse (D-RI) sent a letter to HHS Secretary Azar urging him to ensure the U.S. healthcare system continues to improve care quality and curb escalating healthcare costs through value-based payment. Press release: http://bit.ly/2FPVHVY  Letter: http://bit.ly/2FRDZRV

Mental Health and Substance Abuse –

  • On March 19, the White House released a fact sheet for its plan to address the opioid crisis, the ‘Initiative to Stop Opioid Abuse and Reduce Drug Supply and Demand.’ The plan focuses on three broad areas: reducing demand through education, awareness and preventing over-prescribing, reducing the flow of illicit drugs across borders and within communities, and saving lives by expanding opportunities for proven treatments for opioid and other drug addictions. Fact sheet: http://bit.ly/2ue1Vcy
  • On March 20, Substance Abuse and Mental Health Services Administration announced it will award additional grant funding to three states that have been hit especially hard by the opioid crisis – Massachusetts, New Hampshire, and West Virginia. Press release: http://bit.ly/2HU196F
  • On March 20, Sen. Smith (D-MN) sent a letter to the U.S. Department of Agriculture requesting a roundtable on rural opioid misuse to be held in Minnesota. Press release with text of letter: http://bit.ly/2HSqqOE
  • On March 22, HHS Secretary Azar held a listening session with state officials who work on prescription drug monitoring programs, during which participants discussed ways in which their states have developed and enhanced PDMPs. Press release: http://bit.ly/2IKwGcm

Health IT –

  • On March 21, the Health IT Advisory Committee released a set of recommendations for the HHS Office of the National Coordinator related to the Trusted Exchange Framework and Common Agreement, arguing that ONC need to clearly define its policy goals and calling on ONC to reduce duplicative requirements in the framework. Recommendations: http://bit.ly/2m15In8

Drug and Medical Device Regulation

  • On March 20, Food and Drug Administration (FDA) released an advanced notice of proposed rulemaking on flavored tobacco products, and seeking information on how such products attract youth to initiate tobacco product use. Comments are due by June 19. Press release: http://bit.ly/2HRTxBs ANPRM: http://bit.ly/2HSm5em
  • On March 20, FDA Commissioner Gottlieb penned a blog post announcing the agency’s plans to increase the scope and effectiveness of monitoring of FDA-regulated products arriving at international mail facilities. Blog post: http://bit.ly/2sjaaDj
  • On March 21, Food and Drug Administration Commissioner Gottlieb penned a blog post describing the FDA’s efforts to prevent illegal products with hidden drug ingredients from entering the U.S. Blog post: http://bit.ly/2sjaaDj
  • On March 23, U.S. Government Accountability Office released a report finding that the Patient-Centered Outcomes Research Institute and HHS expect to receive about $4 billion from a fund established by the ACA to support research comparing the effectiveness of available treatments. Summary with link to report: http://bit.ly/2IOo9Fo

Veterans’ Health

  • On March 20, House Veterans Affairs Committee Chair Roe (R-TN) sent a letter to House Minority Leader Pelosi (D-CA) urging her to support a bipartisan, bicameral agreement on the future of VA community care, an expansion of VA’s caregiver program, and an asset review to strengthen VA’s infrastructure. Press release: http://bit.ly/2DJU8D0 Letter: http://bit.ly/2DJfb8R
  • On March 20, Sen. Smith (D-MN) sent a letter to Department of Veterans Affairs Secretary Shulkin, requesting information on alleged issues with a digital health system designed for clinics and hospitals that treat veterans and service members. Press release with text of letter: http://bit.ly/2FPB8Zu
  • On March 23, VA and the U.S. Digital Service announced the launch of an improved Appeals Status tool to increase transparency and enable veterans to track the progress of their benefits claims appeals. Press release: http://bit.ly/2IUAKHi

Misc. –

  • On March 20, Senate HELP Committee Ranking Member Murray (D-WA) sent a letter to President Trump raising concerns about his expected nominee for Director of the Centers for Disease Control and Prevention. Press release: http://bit.ly/2DJD8ws Letter: http://bit.ly/2HU3NJH
  • On March 20, U.S. Preventive Services Task Force issued a final recommendation statement on screening for risk cancer, finding that there is insufficient evidence to recommend for or against clinicians using visual exams to screen adults for skin cancer. Recommendation: http://bit.ly/2DGMCZz