What’s Ahead: This Week

 Notable Policy Events –

  • Monday, April 30 – Wednesday, May 2
  • Monday, April 30
    • Patient-Centered Outcomes Research Institute, “Board of Governors Meeting: Medication-Assisted Treatment Delivery for Pregnant Women with Opioid Use Disorder and Symptom Management for Patients with Advanced Illness.” Additional information: https://bit.ly/2KibvPT
  • Tuesday, May 1
    • National Quality Forum, “Driving Patient Safety and Quality through Opioid Stewardship.” Additional information: http://bit.ly/2vWZwEb
  • Wednesday, May 2 – Friday, May 4
    • Partnership for a Healthier America, “Building a Healthier Future Summit.” Additional information: https://bit.ly/2HNK0iL
  • Thursday, May 3
    • CMS, “Public Forum: Oncology Care Model – Stakeholder Feedback.” Additional information: https://bit.ly/2HzSPJz
    • Politico & PhRMA, “Deconstructing the Prescription Drug Supply Chain.” Additional information: https://bit.ly/2HzN3aD


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

 Appointments –

  • On April 24, President Trump nominated James W. Carroll, Jr. to be Director of National Drug Control Policy. He previously served as General Counsel in the Office of Management and Budget. Press release: https://bit.ly/2vHtFqQ
  • On April 26, Rear Adm. Ronny L. Jackson withdrew his name from the nomination process to be Secretary of Veterans Affairs.

Legislative Activity –

  • On April 23, Reps. Kuster (D-NH), Jenkins (R-WV), MacArthur (R-NJ), and Norcross (D-NJ) introduced the Surveillance and Testing of Opioids to Prevent (STOP) Fentanyl Deaths Act (H.R. 5580), which would create grant funding to assist states and municipalities in identifying fentanyl in drug overdoses. Press release: https://bit.ly/2KiCJ8Y Text: https://bit.ly/2JwRoMo
  • Also on April 23, Reps. Brooks (R-IN) and Schneider (D-IL) introduced the Abuse Deterrent and Prescriber Training (ADAPT) Act of 2018 (H.R. 5581), which would ensure that opioid prescribers have the education necessary to safely prescribe opioids. Press release: https://bit.ly/2r3pcKi Text: https://bit.ly/2HxdVfs
  • Also on April 23, Reps. Carter (D-GA), Loebsack (D-IA), and Reed (R-NY) introduced the Abuse Deterrent Access Act of 2018 (H.R. 5582), which would direct the Secretary of HHS to conduct a study on barriers to accessing abuse deterrent opioid formulations for chronic pain patients enrolled in Medicare. Press release: https://bit.ly/2Hz8RqU Text: https://bit.ly/2r2VjJm
  • Also on April 23, Reps. Lujan (D-NM) and Johnson (R-OH) introduced the Peer Support Communities of Recovery Act (H.R. 5587), which would authorize certain recovery services grants to be used to establish regional technical assistance centers. Text: https://bit.ly/2r5TIm7
  • Also on April 23, Sens. Booker (D-NJ), Nelson (D-FL), Carper (D-DE), and Coons (D-DE) reintroduced the Reducing Obesity in Youth Act (S. 2726), which encourages local partnerships that directly target populations with the highest childhood obesity rates. Press release: https://bit.ly/2FlEgHy
  • Also on April 23, Senate Majority Leader McConnell (R-KY) introduced the Comprehensive Addiction Recovery through Effective Employment and Reentry (CAREER) Act (S. 2730), which establishes a pilot program to help individuals in recovery from a substance use disorder transition from treatment to independent living and the workforce. Press release: https://bit.ly/2HRp7D8 Text: https://bit.ly/2HxeJRN
  • On April 24, Senate HELP Committee unanimously voted to approve the Opioid Crisis Response Act of 2018 (S. 2680). The bill now moves to the full Senate for consideration. Press release: https://bit.ly/2qZN7JJ Text: https://bit.ly/2HxlpeE
  • Also on April 24, Senate HELP Committee approved by a vote of 22-1 the Over-the-Counter Drug Safety, Innovation, and Reform Act (S. 2315), which modernizes the OTC drug approval process. The bill now moves to the full Senate for consideration. Press release: https://bit.ly/2qZN7JJ Text: https://bit.ly/2vPeDQ4
  • Also on April 24, Reps. Kinzinger (R-IL), Clarke (D-NY), LaHood (R-IL), and Davis (D-IL) introduced the Opioid Addiction Action Plan (H.R. 5590), which would require CMS to develop an opioid addiction action plan with stakeholder feedback and then report it to Congress by January 1, 2019. Press release: https://bit.ly/2HVfvY0 Text: https://bit.ly/2I1kOmh
  • Also on April 24, Reps. Turner (R-OH) and Moulton (D-MA) introduced the Sharing Health Information to Ensure Lifesaving Drug Safety (SHIELDS) Act (H.R. 5591), which would require the Department of Defense to establish a prescription drug monitoring program. Press release: https://bit.ly/2r34v0W Text: https://bit.ly/2r2I6B6
  • Also on April 24, Reps. Matsui (D-CA) and Harper (R-MS) introduced the Improving Access to Remote Behavioral Health Treatment Act (H.R. 5594), which would increase access to medication-assisted treatment at community behavioral health clinics through the use of telemedicine under the Ryan Haight Act. Press release: https://bit.ly/2HC50p1 Text: https://bit.ly/2Jxi8ws
  • Also on April 24, Rep. Carter (R-GA) and Collins (R-NY) introduced the 340B Optimization Act (H.R. 5598), which would require disproportionate share hospitals to report their low-income utilization rate for outpatient services in addition to their low-income utilization rate for inpatient services in both the main hospital and child site setting. Press release: https://bit.ly/2Hwtmk3 Text: https://bit.ly/2Kho11U
  • Also on April 24, Reps. Matsui (D-CA) and Cardenas (D-CA) introduced the Access to Telehealth Services for Opioid Use Disorders Act (H.R. 5603), which would allow the Secretary of HHS to waive Medicare restrictions on reimbursement for telehealth services provided to patients suffering from an opioid use disorder. Press release: https://bit.ly/2HC50p1 Text: https://bit.ly/2I1magR
  • Also on April 24, Rep. Ruiz (D-CA) introduced the Advancing High Quality Treatment for Opioid Use Disorders in Medicare Act (H.R. 5605), which would increase access for seniors on Medicare to comprehensive addiction treatment services. Press release: https://bit.ly/2FlZ4ih
  • Also on April 24, Sens. Baldwin (D-WI) and Cassidy (R-LA) introduced the Restricting Entrance and Strengthening the Requirements on Import Controls for Trafficking (RESTRICT) Illicit Drugs Act (S. 2739), which would give the FDA more authority to prevent fentanyl, opioids, and other illicit synthetic drugs from entering the country through International Mail Facilities. Press release: https://bit.ly/2vNNOLO Text: https://bit.ly/2r4BqSk
  • Also on April 24, Senate Finance Committee Chair Hatch (R-UT) and Sen. Whitehouse (D-RI) introduced the SARMs Control Act of 2018 (S. 2742), which would extend the DEA’s authority to regulate selective androgen receptor modulators. Press release: https://bit.ly/2HvWD2r Text: https://bit.ly/2r4bh6V
  • On April 25, House Energy and Commerce Subcommittee on Health voted to approve 56 bills related to the opioid crisis. The bills now move to the full committee for consideration. Press release: https://bit.ly/2JtkCMf
  • Also on April 25, House Appropriations Committee, Subcommittee on Military Construction and the VA approved a $96.9 billion FY19 draft spending bill, which includes a $3.9 billion increase in discretionary funding to the VA. The bill now moves to the full committee for consideration. Press release: https://bit.ly/2I2hXcR Text: https://bit.ly/2JvsAVa
  • Also on April 25, Sens. Manchin (D-WV), Capito (R-WV), and Kaine (D-VA) introduced the Handle with Care Act (S. 2754), which would establish a grant program to address the impact of substance use-related trauma on children and youth in public schools. Press release: https://bit.ly/2r4kqvj
  • On April 26, Reps. Bera (D-CA), Kuster (D-NH), Schrader (D-OR), Schneider (D-IL), Rice (D-NY), Delaney (D-MD), and Peters (D-CA) introduced the Pathway to Universal Coverage Act (H.R. 5624), which would provide grants for States to pilot opt-out insurance coverage for individuals eligible for premium assistance or Medicaid. Press release: https://bit.ly/2HR2AX8
  • Also on April 26, Reps. Bera (D-CA), Kuster (D-NH), Schneider (D-IL), Delaney (D-MD), and Peters (D-CA) introduced the Easy Enrollment Act (H.R. 5625), which would align health care open enrollment with tax season. Press release: https://bit.ly/2HR2AX8
  • Also on April 26, Reps. McKinley (R-WV), Tonko (D-NY), and Cicilline (D-RI) introduced the Access to Increased Drug Disposal (AIDD) Act of 2018 (H.R. 5628), which would establish a demonstration program under which the DEA provides grants to certain states to increase participation in drug takeback programs. Press release: https://bit.ly/2vOSaCI Text: https://bit.ly/2HZj6od
  • Also on April 26, Rep. Gaetz (R-FL) led a group of 26 co-sponsors in introducing the Medical Cannabis Research Act of 2018 (H.R. 5634), which would increase the number of manufacturers registered under the Controlled Substances Act to manufacture cannabis for research purposes. Press release: https://bit.ly/2KkuGZ1
  • Also on April 26, Rep. Grothman (R-WI) introduced the Responsible Opioid Prescription Act (H.R. 5635), which would impose restrictions under the Medicaid program with respect to opioid prescriptions. Press release: http://bit.ly/2vUan1K
  • Also on April 26, Sens. Heller (R-NV), Menendez (D-NJ), and Isakson (R-GA) introduced the Opioid Addiction Action Plan Act (S. 2789), which would require HHS and CMS to develop a plan by January 1, 2019 to prevent opioid addiction and increase access to medication-assisted treatment. Press release: https://bit.ly/2FnTOdM
  • Also April 27, Reps. Curtis (R-UT), Bishop (R-UT), Stewart (R-UT), Diaz-Balart (R-FL) and Love (R-UT) introduced the Protecting Against Opioid Prescription-abuse During Prenatal (POPPY) Study Act (H.R. 5646), which would require the Secretary of HHS to submit to Congress a report on opioids prescribing practices for pregnant women. Press release: http://bit.ly/2vVQqr7

ACA Implementation and Market Stabilization –

  • On April 23, 47 Senate Democrats sent a letter to HHS Secretary Azar urging him to halt a proposed regulation that would “create junk health insurance plans that would return us to the days when insurance companies could refuse to cover people with pre-existing conditions and raise premiums significantly for older Americans.” Press release: http://bit.ly/2vXmz1I Letter: http://bit.ly/2vWT1Ba
  • Also on April 23, Idaho Insurance Department released a statement noting that CMS has extended the date for the state’s response to the agency’s letter regarding state-based plans until at least May 5. Press release: https://bit.ly/2Kj9eDX
  • On April 25, House Energy & Commerce Committee Subcommittee on Health Ranking Member Green (D-TX) led several Democrats of the Texas congressional delegation in a letter to Texas Gov. Abbott calling on the Governor to increase coverage and improve the affordability of care in the state. Press release: https://bit.ly/2vYvUGe Letter: https://bit.ly/2I3IxSZ
  • On April 26, Texas Attorney General Paxton and Wisconsin Attorney General Schimel led a 20-state coalition in filing a motion seeking a preliminary injunction against the Affordable Care Act. The next day, California Attorney General Becerra filed a motion requesting that their effort to intervene in the case be expedited. Press release: https://bit.ly/2qZN69F Motions: https://bit.ly/2HvvWe9 and http://bit.ly/2ra3yUV
  • On April 27, Rep. Kaptur (D-OH) led four members of the Ohio congressional delegation in a letter to Ohio Governor Kasich urging him to take action to stabilize the state’s individual insurance market. Press release: http://bit.ly/2r9y8xO Letter: http://bit.ly/2HZ46q7
  • Also on April 27, Reps. DeLauro (D-CT), Larson (D-CT), Courtney (D-CT) and Esty (D-CT) sent a letter to Connecticut Governor Malloy outlining several recommended actions for the state of Connecticut to take to improve the state’s individual insurance markets. Press release: http://bit.ly/2rb2S1i Letter: http://bit.ly/2r8HLgg

Medicare –

  • On April 24, CMS issued proposed updates to Medicare payment policies and rates under the inpatient prospective payment system and long-term care (LTC) hospital prospective payment system, including a proposed 3.4 percent increase in payments. The rule additionally proposes several changes relating to hospital quality reporting, price transparency, and interoperability, and includes a request for information (RFI) on interoperability. Comments are due by June 25. Press release: https://go.cms.gov/2HVES9B Azar statement: https://bit.ly/2JrMVe8 Fact sheet: https://go.cms.gov/2r8JthB Proposed rule: https://bit.ly/2qVhFNK
  • On April 26, CMS announced a new Data Driven Patient Care Strategy as part of the MyHealthEData initiative, which strives to make CMS data more accessible and usable in a secure manner to drive system transformation. CMS also announced the availability of 2015 Medicare Advantage Encounter Data as pat of the initiative. Press release: https://go.cms.gov/2r7QjDZ Fact sheet: https://go.cms.gov/2KgPFMm
  • Also on April 26, CMS announced the extension of payment adjustment for low-volume hospitals and the Medicare-dependent hospital program under hospital inpatient prospective payment systems for acute care hospitals for FY18. Document: https://bit.ly/2Hx2xwd
  • On April 27, CMS released proposed updates to Medicare policies and rates under the Skilled Nursing Facilities Prospective Payment System (SNF PPS), Inpatient Rehabilitation Facilities Prospective Payment System (IRF PPS), the Hospice Wage Index and Payment Rate Update, and the Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS). Each of the proposed rules also included an RFI on requiring interoperability. Comments are due by June 26. Press release: https://go.cms.gov/2vVtYhM SNF Fact sheet and proposed rule: https://go.cms.gov/2r8ZQuN and http://bit.ly/2r8W4RQ IRF Fact sheet and proposed rule: https://go.cms.gov/2HVI8V0 and http://bit.ly/2HZjF0X Hospice fact sheet and proposed rule: https://go.cms.gov/2I3Avfu and http://bit.ly/2HZjAdF IPF fact sheet and proposed rule: https://go.cms.gov/2HWs0Tn and http://bit.ly/2HZjDpR

 Medicaid –

  • On April 27, Vice Chair of the Senate Committee on Indian Affairs Udall (D-NM) led a bipartisan group of 10 senators in expressing concern that HHS and CMS have “expressed views that challenge the unique legal status and well established protections given to Indian tribes,” specifically expressing concern that the Administration will not exempt American Indian and Alaska Natives from Medicaid work requirements. Press release: http://bit.ly/2I0K5zG Letter: http://bit.ly/2r9Ehdk

Payment and Delivery System Reform –

  • On April 23, CMS publicly released the comments it received in response to its Fall 2017 Request for Information (RFI) on CMMI’s New Direction to collect ideas on market-driven reforms to focus on patient-centered care. Press release with link to comments: https://go.cms.gov/2Hy3MLE Comments: https://bit.ly/2ihhElA
  • Also on April 23, CMS issued an RFI seeking broad input on direct provider contracting (DPC) between payers and primary care or multi-specialty groups to inform potential testing of a DPC model within the Medicare fee-for-service program, Medicare Advantage, and Medicaid. Comments are due by May 25. Press release: https://go.cms.gov/2jcsaYL RFI: http://bit.ly/2jbIPeM
  • On April 25, U.S. Government Accountability Office (GAO) released a report on CMS Innovation Center’s model implementation and center performance, finding that since 2010, the center has tested or is in the process of testing 37 models, of which, two have been recommended for expansion. Summary with link to report : http://bit.ly/2jgcZgV
  • On April 26, CMS released a payment methodology paper for the Comprehensive Primary Care Plus model. Paper: http://bit.ly/2jnlWq8

Mental Health and Substance Abuse –

  • On April 23, HHS released a report on state practices in treatment/therapeutic foster care, including the key program elements as defined by states and how states differentiate treatment foster care from foster care. Summary: https://bit.ly/2HvBZzC Report: https://bit.ly/2I1tgSK
  • Also on April 23, Sens. Klobuchar and Smith (D-MN) led 15 of their Senate colleagues in a letter to HHS Secretary Azar, urging him to take immediate action to reduce the price of naloxone. Press release with text of letter: https://bit.ly/2Hxh3UQ
  • Also on April 23, HHS released a Mental Health and Substance Use Disorder Parity Action Plan, which describes the steps HHS has taken to-date, as well as planned steps, to maintain momentum on parity enforcement and implementation. Deputy Secretary Hargan’s blog post: https://bit.ly/2JwoITM Action plan: https://bit.ly/2vRFMld
  • Also on April 23, CMS released draft frequently asked questions (FAQ) about mental health and substance use disorder parity implementation and the 21st Century Cures Act Part XX. Comments are due by June 22. FAQ: http://bit.ly/2jcBmfv
  • Also on April 23, CMS released a self-compliance tool for the Mental Health Parity and Addiction Equity Act (MHPAEA) and a form to request documentation from an employer-sponsored health plan or an insurer concerning treatment limitations. Tool: http://bit.ly/2jaScLI Form: http://bit.ly/2jhgLqJ
  • On April 24, HHS renewed its Public Health Emergency declaration for the opioid crisis. This is the second 90-day renewal. Renewal: https://bit.ly/2I2frDr
  • On April 25, HHS Secretary Azar and Surgeon General Adams released a statement praising the private sector for its support of the Surgeon General’s recent naloxone advisory. Press release: https://bit.ly/2I0vfqj

Drugs and Medical Device Regulation

  • On April 23, Food and Drug Administration (FDA) released draft guidance for developing depot buprenorphine products. Comments are due by June 23. Document: https://bit.ly/2F3Dmzo
  • Also on April 23, Rep. Duffy (R-WI) led 26 other members of Congress in a letter to President Trump addressing the “free riding” of United States trading partners on American innovative pharmaceuticals. Press release: https://bit.ly/2HtLizQ Letter: https://bit.ly/2r5Ydgf
  • On April 24, Food and Drug Administration (FDA) Commissioner Gottlieb testified before the Senate Appropriations Committee, Subcommittee on Agriculture, Rural Development, FDA, and Related Agencies regarding the agency’s FY19 budget. Themes of the Commissioner’s testimony included modernization of generic drug development, promoting more widespread use of generic drugs, and promoting data interoperability. Testimony: https://bit.ly/2I3duGK
  • Also on April 24, FDA Commissioner Gottlieb released a statement on new enforcement actions and a Youth Tobacco Prevention Plan to stop youth use of and access to JUUL and other e-cigarettes. Press release: https://bit.ly/2qUJYff
  • On April 26, FDA Commissioner Gottlieb delivered remarks to Academy Health’s 2018 Health Datapalooza in which he discussed transforming FDA’s approach to digital health through a digital health innovation action plan, the launch of a program to apply digital health to drugs, and artificial intelligence. Remarks: https://bit.ly/2HVewHw

 Military & Veterans’ Health –

  • On April 25, Department of Veterans Affairs issued a statement on VA’s near-term priorities under Acting Secretary Wilkie, which include working with Congress to get community care reform legislation passed before Memorial Day and finalizing a decision on the Department’s electronic health record modernization. Press release: https://bit.ly/2HwM2o0
  • Also on April 26, GAO released a report recommending that the Defense Health Agency should improve tracking of serious adverse medical events and monitoring of required follow-up. Report: https://bit.ly/2r4O4RT
  • On April 27, VA Acting Secretary Wilkie released a statement calling on Congress to take congressional action on authorizing a permanent Veterans Choice program. Press release: http://bit.ly/2jcCSyd

 Misc. –

  • On April 23, HHS announced the purchase of $25.2 million worth of anthrax antitoxin for the Strategic National Stockpile as part of the department’s ongoing national preparedness efforts. Press release: https://bit.ly/2I3L2Vl
  • On April 24, CDC published a study finding that births to women aged 10 to 14 declined between 2000 and 2016. Report: https://bit.ly/2JyigeW
  • On April 26, HHS announced a partnership with the American Society of Nephrology to launch the Kidney Innovation Accelerator (KidneyX), which will engage relevant stakeholders to enable and accelerate the commercialization of kidney disease therapies. Press release: https://bit.ly/2HyvWWQ
  • Also on April 26, Centers for Disease Control and Prevention (CDC) released a report showing that autism prevalence in the United States increased slightly between 2014 and 2016. Press release: https://bit.ly/2KiYNQO Report: https://bit.ly/2HxoivY
  • Also on April 26, GAO released a report recommending that future collaborations on housing and health services should include relevant agencies and define outcomes. Report: https://bit.ly/2HvwIrz
  • On April 27, ASPE released a report to the Advisory Council on Alzheimer’s Research, Care, and Services presenting the results of the National Research Summit on Care, Services, and Supports for Persons with Dementia and their Caregivers. Summary: https://bit.ly/2HveBOu Report: https://bit.ly/2r4dIpd