What’s Ahead: This Week

Hearings/Markups –

• Tuesday, June 19
  • Senate HELP Committee, “Effective Administration of the 340B Drug Pricing Program.”
  • Senate Aging Committee, “Changing the Trajectory of Alzheimer’s: Reducing Risk, Detecting Early Symptoms, and Improving Data.”
• Wednesday, June 20
  • Senate Homeland Security & Governmental Affairs Committee, “Medicaid Fraud and Overpayments: Problems and Solutions.”
  • Senate HELP Committee, “Executive Session: S. 3029, S. 1222, S. 808, S. 3039, S. ___, a bill to reauthorize the Carl D. Perkins Career and Technical Education Act, and Nominations.”
  • House Veterans Affairs Committee, Subcommittee on Health, “More than just filling vacancies: A closer look at VA hiring authorities, recruiting and retention.”
  • House Energy & Commerce Committee, Subcommittee on Oversight and Investigations, “Examination of the GAO Audit Series on HHS Cybersecurity.“

Notable Policy Events –

• Monday, June 18
  • American Institutes for Research, “Briefing: Using Data to Drive Community-Based Approaches to the Opioid Crisis.” Additional information: https://bit.ly/2HKhk66
• Tuesday, June 19
  • Bipartisan Policy Center, “Counting the Costs: Introduction to CBO’s Updated Health Insurance Model.” Additional information: https://bit.ly/2LNaNKb
• Wednesday, June 20
  • Health IT Advisory Committee, “Health IT Advisory Committee Meeting.” Additional information: http://bit.ly/2Myktt6
  • CMS, “Advisory Panel on Outreach and Education.” Additional information: http://bit.ly/2MyROnV
  • Washington Post, “The Health 202 Live: Health Care Costs in America.” Additional information: https://wapo.st/2JHMHjs
• Thursday, June 21
  • Workers Compensation Research Institute, “Webinar: Impact of Opioid Prescriptions on Duration of Temporary Disability.” Additional information: https://bit.ly/2MnsFMV

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

 Budget and Appropriations –

• On June 12, House Budget Committee Minority Staff released a guide to federal spending for FY 2019, which provides a detailed look at federal spending by function. Press release: https://bit.ly/2MndxPB Report: https://bit.ly/2JIIuw3
• On June 13, House Appropriations Committee, Subcommittee on Labor, Health and Human Services, and Education approved by voice vote the Labor-HHS appropriations bill, which would allocate $89.2 billion in discretionary funding to HHS for FY 2019. Press release: http://bit.ly/2HXMLK0  Text: https://bit.ly/2Mqdx1h

 Legislative Activity –

• On June 11, Sens. Manchin (D-WV) and Sullivan (R-AK) introduced S. 3048, which would direct the Comptroller General to evaluate and report on the inpatient and outpatient treatment capacity, availability, and needs of the United States. Press release: http://bit.ly/2MzQoK2
• On June 12, the House voted to pass 25 bills introduced as part of a suite of bills intended to help address the opioid crisis. The House passed additional bills on Wednesday and Thursday, totaling 39 for the week of the more than 70 bills scheduled to be voted on in total. Additionally, on June 13, House Energy and Commerce Committee Chair Walden (R-OR) and Ranking Member Pallone (D-NJ), along with Ways and Means Chair Brady (R-TX) and Ranking Member Neal (D-MA), introduced the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (H.R. 6), which will serve as the underlying vehicle for the majority of House-passed bills to combat the opioid crisis. The approved bills now move to the Senate for consideration. Press release: https://bit.ly/2HKWfIJ Press release: https://bit.ly/2y5iXfa
• Also on June 12, Rep. Matsui (D-CA) introduced the Stretching Entity Resources for Vulnerable (SERV) Communities Act (H.R. 6071), which would clarify the intent of the 340B program and provide for enhanced program integrity. Press release: https://bit.ly/2t3OMPy Text: https://bit.ly/2LPlhJg
• Also on June 12, the Senate Finance Committee unanimously voted to approve the Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018. The bill seeks to improve how Medicare, Medicaid, and human services programs respond to the opioid crisis. The bill now moves to the full Senate for consideration. Press release: https://bit.ly/2Ml7BGJ
• Also on June 13, Reps. Mullin (R-OK) and Blumenauer (D-OR) introduced the Overdose Prevention and Patient Safety Act (H.R. 6082), which would protect medical records related to substance use disorder under existing HIPAA privacy regulations. Bill text: https://bit.ly/2sZgMEI
• Also on June 13, Reps. Eshoo (D-CA) and Lance (R-NJ) introduced the Prematurity Research Expansion and Education for Mothers Who Deliver Infants Early (PREEMIE) Act (H.R. 6085), which would reauthorize the CDC’s research and data collection on infants born prematurely and infant health programs at HRSA. Press release: https://bit.ly/2sUkAY6
• Also on June 13, Reps. Jayapal (D-WA), Schakowsky (D-IL), and Pocan (D-WI) introduced the State-Based Universal Health Care Act of 2018 (H.R. 6097), which would authorize the establishment of and provide support for state-based universal health care systems that provide comprehensive health benefits to state residents. Press release: http://bit.ly/2JLBoL1
• Also on June 13, Sens. Jones (D-AL), Kaine (D-VA), King (I-ME), Klobuchar (D-MN), Nelson (D-FL), and Smith (D-MN) introduced the Smart Choices Act (S. 3059) which would require MACPAC to publish an annual report on the estimated impact of Medicaid expansion for states that expanded as well as those that did not. Press release: https://bit.ly/2JO4TeD
• On June 14, the Senate Judiciary Committee approved by a vote of 16-5 the CREATES Act (S.974), which would allow generic drugmakers to obtain samples of branded drugs for use in generic drug development Press release: http://bit.ly/2JNZXXO
• Also on June 14, Reps. Esty (D-CT), Kuster (D-NH), and MacArthur (R-NJ) introduced the Combating the Opioid Epidemic through Forensic Drug Testing Act (H.R. XXX). Which would XXX. Press release: http://bit.ly/2MwvFXf

 ACA Implementation –

• On June 12, Senate HELP Committee Chair Alexander (R-TN) released a statement in opposition to the Department of Justice’s legal brief filed in a Texas lawsuit in federal court about the constitutionality of the pre-existing condition protections in the Affordable Care Act following the repeal of the individual mandate. Statement: https://bit.ly/2LPIs6f
• On June 13, House Energy and Commerce Committee Ranking Member Pallone (D-NJ), House Ways and Means Committee Ranking Member Neal (D-MA), House Judiciary Committee Ranking Member Nadler (D-NY), and House Education and Workforce Committee Ranking Member Scott (D-VA) signed a letter to Department of Health and Human Services (HHS) Secretary Azar and Centers for Medicare & Medicaid Services (CMS) Administrator Verma highlighting concerns regarding the Department of Justice’s decision not to defend key patient protections of the Affordable Care Act in federal court. Press release: https://bit.ly/2yaXx02 Letter: https://bit.ly/2JAsUXi
• Also on June 13, House Judiciary Committee Ranking Member Nadler (D-NY) led a letter signed by 45 democratic representatives to Attorney General Sessions requesting information related to the department’s decision to not defend the ACA in the Texas vs. USA case. Press release: http://bit.ly/2MBwEFF Letter: http://bit.ly/2JP2QaP
• On June 14, the U.S. Court of Appeals for the Federal Circuit ruled that the federal government is not required to fund risk corridor payments owed to insurers through the ACA. Decision: http://bit.ly/2JKVdlO
• Also on June 14, Sens. Durbin (D-IL) and Duckworth (D-IL) led a group of 45 senators in a letter to HHS Secretary Azar, Treasury Secretary Mnuchin, and Labor Secretary Acosta urging the Administration to halt the implementation of a regulation that would expand access to short-term limited-duration health insurance plans. Press release: http://bit.ly/2JOhS0o Letter: http://bit.ly/2JMgED1
• On June 15, Senate HELP Committee Chair Alexander (R-TN) led a group of 30 senate republicans in a letter to HHS Secretary Azar, Labor Secretary Acosta and Treasury Secretary Mnuchin urging them to expand access to lower cost employer insurance to millions more Americans through Association Health Plans. Press release: http://bit.ly/2K4beCU Letter: http://bit.ly/2K2U2gM
• Also on June 15, Senate HELP Committee Chair Alexander (R-TN) sent a letter to HHS Secretary Azar urging him to take actions to make section 1332 State Innovation Waivers “a more powerful tool for state health insurance reforms.” Press release: http://bit.ly/2JZvFAJ Letter: http://bit.ly/2K2sOXQ

 Medicare –

• On June 12, HHS Office of Inspector General (OIG) released a report showing that most Medicare claims for replacement positive airway pressure device supplies did not comply with Medicare requirements. Summary: https://bit.ly/2JyOrPY Report: https://bit.ly/2t3FYJC
• On June 15, Medicare Payment Advisory Commission (MedPAC) released its June 2018 Report to Congress. Press release: http://bit.ly/2HYT3tc Fact sheet: http://bit.ly/2HWBCta Report: http://bit.ly/2I01Niw

 Medicaid –

• On June 11, CMS released a letter to State Medicaid Directors providing guidance on which funding authorities might support leveraging health technology efforts against the opioid crisis. Press release: https://go.cms.gov/2sRRNDr Guidance: https://bit.ly/2Jzk0sP
• Also on June 11, CMS released an informational bulletin providing states with considerations when designing approaches to treatment of infants with neonatal abstinence syndrome (NAS), including Medicaid options and limitations. Press release: https://go.cms.gov/2sRRNDr Bulletin: https://bit.ly/2y7mIAN
• On June 12, CMS released a document showing the number of children ever enrolled in CHIP and Medicaid in FY 2016 and FY 2017. Document: https://bit.ly/2HLsqYC
• On June 15, Medicaid and CHIP Payment and Access Commission (MACPAC) released its June 2018 Report to Congress on Medicaid and CHIP, which includes recommendations to change statutory provisions that prevent state Medicaid programs from paying the lowest price for certain drugs and clarify regulations on protecting the privacy of patients with substance use disorder. Report: http://bit.ly/2JOnKHn

 New Payment and Delivery System Reforms –

• On June 14, U.S. Government Accountability Office (GAO) issued a request for nominations to serve on the Physician-Focused Payment Model Technical Advisory Committee (PTAC). Submissions are due by July 20. Notice: http://bit.ly/2JLWwky
• On June 15, HHS released a letter in response to 12 proposals submitted by the Physician-Focused Payment Technical Advisory Committee (PTAC). Letter: http://bit.ly/2ylnsCc

Mental Health and Substance Abuse –

• On June 11, CMS published a Roadmap to Address the Opioid Epidemic, which highlights the agency’s key areas of focus and successes thus far. Blog: https://bit.ly/2y2nK0U Roadmap: https://go.cms.gov/2LM0A0L
• Also on June 11, Substance Abuse and Mental Health Services Administration (SAMHSA) published an update to its Opioid Overdose Prevention Toolkit, which is designed to help health care providers, families, and other community members prevent overdose deaths related to opioid use. Press release: https://bit.ly/2y8fVGP
• Also on June 11, HHS released a brief describing the research methods used to produce the findings in Substance Use, the Opioid Epidemic, and Child Welfare Caseloads: A Mixed Methods Study. Brief: https://bit.ly/2sTlAeU
• On June 12, National Institutes of Health (NIH) released an outline of its interdisciplinary FY 2018 research plan for the Helping to End Addiction Long-term (HEAL) Initiative. Press release: https://bit.ly/2sS9LWt
• On June 14, HHS released a report on non-opioid alternatives for managing chronic pain, finding that there are no published studies that directly compare opioids to alternatives for pain management, and most lack evidence on long-term effectiveness. Summary with link to report: http://bit.ly/2sXKom6
• Also on June 14, Food and Drug Administration (FDA) announced the approval of the first generic version of Suboxone sublingual film, which may increase access to treatment for opioid dependence. Press release: http://bit.ly/2sYSL0x HHS press release: http://bit.ly/2sYhP84
• On June 15, HHS announced the availability of $350 million in new funding to expand access to substance use disorder and mental health services at community health centers across the country. Applications are due by July 16. Press release: http://bit.ly/2Mwcj4u
• Also on June 15, SAMHSA announced it is now accepting applications for $930 million in State Opioid Response Grants. Applications will be due by August 13. Press release: http://bit.ly/2MBarYj

Drug Prices and Regulation –

• On June 11, Sens. Smith (D-MN) and Warren (D-MA) penned a letter to HHS Secretary Azar highlighting their concerns with the Administration’s drug pricing blueprint. Press release: https://bit.ly/2y81hiL Letter: https://bit.ly/2sWyhWc
• On June 12, FDA Commissioner Gottlieb released a statement and guidance on new efforts to advance medical product communications to support drug competition and value-based health care. Statement: https://bit.ly/2t1VfL2 Guidance: https://bit.ly/2l2VQIw
• Also on June 12, FDA Commissioner Gottlieb released a statement on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections. Statement: https://bit.ly/2l5Yai4
• Also on June 12, FDA Commissioner Gottlieb released a statement and draft guidance on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making. Comments are due by September 11. Statement: https://bit.ly/2sSjSul Draft guidance: https://bit.ly/2Mo7RVz

Military & Veterans’ Health –

• On June 12, Department of Veterans Affairs (VA) made public for the first time its annual nursing home ratings. The ratings show that VA nursing home facilities compare closely with private sector nursing homes. Press release: https://bit.ly/2t33sON Ratings: https://bit.ly/2JzxyEH
• Also on June 12, VA announced a partnership with PsychArmor Institute to launch an online suicide-prevention training video, which is designed to equip anyone who interacts with veterans to demonstrate care, support, and compassion when talking with a veteran who could be at risk for suicide. Press release: https://bit.ly/2l5uMbL
• On June 13, GAO released a report finding that independent verification and validation of patient self-scheduling systems was consistent with the Faster Care for Veterans Act of 2016. Summary with link to report: http://bit.ly/2Mupy5F

 Misc. –

• On June 11, Centers for Disease Control and Prevention (CDC) released a data brief describing the increase in preterm births in the United States from 2014 to 2016. Summary: https://bit.ly/2MpFQgb Report: https://bit.ly/2lbiYF7
• On June 14, CDC released a data brief describing the continuing increase in suicide rates in the United States. Summary: https://bit.ly/2sUArWe Report: https://bit.ly/2t8LgDw
• On June 15, CDC released a study finding that there is a significantly higher obesity prevalence among adults in nonmetropolitan counties than in metropolitan counties. Report: http://bit.ly/2JLlL6B