What’s Ahead: This Week

Hearings –

  • Wednesday, October 11
    • House Energy & Commerce Committee, “Examining How Covered Entities Utilize the 340B Drug Pricing Program.”
    • House Energy & Commerce Committee, Subcommittee on Health, “Member Day: Testimony and Proposals on the Opioid Crisis.”

 Notable Policy Events –

  • Wednesday, October 11 – Thursday, October 12
    • Patient-Centered Primary Care Collaborative, “Primary Care Innovations Conference.” Additional information: http://bit.ly/2fQJ7WT
    • National Academy of Medicine, “Advancing Therapeutic development for Pain and Opioid Use Disorders through Public-Private Partnerships – A Workshop.” Additional information: http://bit.ly/2ybS5rV
  • Wednesday, October 11 – Friday, October 13
    • Global Health Care, “Second National MACRA MIPS/APM Summit.” Additional information: http://bit.ly/2xWMlCf
  • Thursday, October 12
    • Alliance for Health Policy, “Measuring Quality for Person-Centered Accountable Care.” Additional information: http://conta.cc/2fPr4Ay
    • S. Chamber of Commerce, “The Opioid Epidemic: From the Front Lines to the Boardroom, Best Practices & Recommendations for Addressing Substance Use.” Additional information: http://uscham.com/2ybzlsk


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


Administration –

  • On October 5, Eric Hargan was sworn in as Deputy Secretary of the Department of Health and Human Services (HHS). Press release: http://bit.ly/2fQ8SXr

FY 2018 Budget Resolution

  • On October 2, Senate Budget Committee Democrats released an alternative budget resolution, which would “stabilize our fiscal outlook and provide critical investments needed to build a stronger future. Press release: http://bit.ly/2fP8d8p Summary: http://bit.ly/2fNXaML Summary Tables: http://bit.ly/2fNXqvd Bill text: http://bit.ly/2fMEWLQ
  • On October 4, Senate Minority Leader Schumer (D-NY), House Minority Leader Pelosi (D-CA), and Ranking Members from the Senate and House Budget Committees, Senate Finance Committee, House Ways & Means Committee, and the House Energy & Commerce Committee sent a letter to President Trump urging him to “keep his promise and reject proposed GOP budgets that cut critical Medicare and Medicaid programs in order to fund tax cuts…” Press release with text of letter: http://bit.ly/2fOfJkg
  • On October 5, the House passed by a vote of 219-206 the fiscal year (FY) 2018 Budget Resolution (H. Con. Res. 71), which, among other provisions, directs lawmakers to find at least $203 billion in savings from mandatory programs. Also on October 5, the Senate Budget Committee approved by a vote of 12-11 its version of the FY18 budget resolution, which would instruct the Finance Committee to pursue tax reform, and reduces nondefense discretionary spending by $632 billion. Press releases: http://bit.ly/2fOnMNX and http://bit.ly/2fOjJB4

Legislative Activity –

  • On October 2, Sens. Stabenow (D-MI) and Blunt (R-MO) introduced the Excellence in Mental Health Act (S. 1905) which would increase the number of states that may conduct Medicaid demonstration programs to improve access to community mental health services. Reps. Lance (R-NJ) and Matsui (D-CA) introduced companion legislation (H.R. 3931) in the House. Press release: http://bit.ly/2xZvqPk
  • On October 3, Reps. Mullin (R-OK) and Ruiz (D-CA) introduced H.R. 3917, which would extend funding for the special diabetes program for Indians. Press release: http://bit.ly/2y04RcR
  • Also on October 3, Rep. Walorski (R-IN) introduced H.R. 3920, which would establish a Medicare demonstration program on the use of third-party interest-free payment arrangements to reduce Medicare hospital Part A bad debt claims. Press release: http://bit.ly/2xZjKMh
  • Also on October 3, Rep. Renacci (R-OH) introduced the Veterans Health Nurse Recruitment and Retention Improvement Act (H.R. 3933), which would establish and reinstate certain reporting requirements regarding efforts to recruit, hire, and retain health care professionals for the Veterans Health Administration. Press release: http://bit.ly/2xZArYc
  • On October 4, the House passed by a vote of 237-189 the Pain-Capable Unborn Child Protection Act (H.R. 36), which would protect pain-capable unborn children by prohibiting physicians from performing an abortion after 20 weeks of pregnancy. On October 5, Sen. Graham (R-SC) and 45 cosponsors introduced similar legislation in the Senate (S. 1922). Press releases: http://bit.ly/2ybHIo1 and http://bit.ly/2ybv6gp
  • Also on October 4, the Senate Finance Committee advanced the Keeping Kids’ Insurance Dependable and Secure (KIDS) Act (S. 1827), which would extend funding for the Children’s Health Insurance Program for five years. The Committee ordered the bill to be reported to the floor without any amendments. Meanwhile, the same day, the House Committee on Energy & Commerce also advanced similar legislation, the Helping Ensure Access for Little Ones, Toddlers and Youth by Keeping Insurance Delivery Stable (HEALTHY KIDS) Act of 2017 (H.R. 3921). 1827 Press release, Chairman’s Mark and bill text: http://bit.ly/2y03drE and http://bit.ly/2ybhBxb and http://bit.ly/2wF2Lex H.R. 3921 bill text: http://bit.ly/2ybhYI5
  • Also on October 4, House Energy & Commerce Committee advanced several healthcare related bills, including: the Community Health and Medical Professionals Improve our Nation (CHAMPION) Act (H.R. 3922); the Furthering Access to Stroke Telemedicine Act of 2017 (HR. 1148); the Steve Gleason Enduring Voices Act of 2017 (H.R. 2465); the Prostate Cancer Misdiagnosis Elimination Act of 2017 (H.R. 2557), H.R. 3120; The Medicare Civil and Criminal Penalties Act (H.R. 3245); H.R. 3263); and the Protecting Access to Diabetes Supplies Act of 2017 (H.R. 3271). Press release: http://bit.ly/2ybeJ3v
  • Also on October 4, Sens. Warner (D-VA) and Scott (R-SC) introduced the Protecting Access to Diabetes Supplies Act of 2017 (S. 1914), which would strengthen rules in case of competition for diabetic testing strips. Press release: http://bit.ly/2xZrlup
  • On October 5, Rep. Roe (R-TN) and four bipartisan cosponsors introduced the Opioid Addiction and Prevention Act of 2017 (H.R. 3964), which would establish additional registration requirements for prescribers of opioids. Press release: http://bit.ly/2fPQw8R
  • Also on October 5, Reps. Trott (R-MI) and Brooks (R-IN) introduced the Internet of Medical Things Resilience Partnership Act (H.R. 3985), which would establish a working group of public and private entities led by the Food and Drug Administration to recommend voluntary frameworks and guidelines to increase the security and resilience of Internet of Medical Things devices. Press release: http://bit.ly/2ybKjxZ

 ACA Market Stabilization, Reform, & Implementation –

  • On October 3, House Committee on Energy & Commerce democrats sent a letter to Committee Chair Walden (R-OR) requesting immediate hearings to consider measures to stabilize the individual insurance markets. Press release: http://bit.ly/2xWK0af Letter: http://bit.ly/2xWOHke
  • Also on October 3, Sens. Portman (R-OH) and Warner (D-VA) introduced the Commonsense Reporting Act of 2017 (S. 1908), which would streamline the employer reporting process and strengthen the eligibility verification process for the premium assistance tax credit and cost-sharing subsidy. Reps. Black (R-TN) and Thompson (D-CA) introduced companion legislation in the House. Press release: http://bit.ly/2y05YZZ Summary: http://bit.ly/2xZpy8z Bill text: http://bit.ly/2y01wue
  • On October 4, House Ways & Means Committee advanced by a vote of 24-13 the Protecting Seniors’ Access to Medicare Act (H.R. 849), which would repeal a provision in the ACA that establishes the Independent Payment Advisory Board. Press release: http://bit.ly/2fNwr33
  • On October 5, Rep. Cramer (R-ND) and 15 bipartisan cosponsors introduced the Access to Marketplace Insurance Act (H.R. 3976), which would amend the ACA to allow for certain third party payments. Press release: http://bit.ly/2ybtvY7
  • Also on October 5, Reps. Renacci (R-OH), Schrader (D-OR), Jenkins (R-KS) and Costa (D-CA) introduced the Simplifying Technical Aspects Regarding Seasonality (STARS) Act (H.R. 3956), which would simplify the treatment of seasonal positions for purposes of the employer shared responsibility requirement. Press release: http://bit.ly/2ybbjOc
  • On October 6, CMS released interim final rules with request for comment (IFC), which provide employers with new flexibility under the ACA in deciding whether to cover abortion services. CMS also released a bulletin for issuers regarding enforcement of section 1303 of the ACA, which applies certain restrictions with respect to coverage of abortion services by qualified health plans. Comments on the IFC are due by December 5. IFC: http://bit.ly/2y4CV7r Bulletin: http://go.cms.gov/2fPx78b
  • Also on October 6, House Energy & Commerce Committee Ranking Member Pallone (D-NJ) and Health Subcommittee Ranking Member Green (D-TX) sent a letter to Committee Chair Walden (R-OR) and Health Subcommittee Chair Burgess (R-TX) requesting immediate hearings to examine the Administration’s readiness for the upcoming Marketplace open enrollment season. Press release: http://bit.ly/2yb5al0 Letter: http://bit.ly/2ybNwOh

Medicare –

  • On October 2, Medicare Payment Advisory Commission (MedPAC) released a report on regional variation in Medicare Part A, B, and D spending and service use. Report: http://bit.ly/2fSvkiK
  • Also on October 2, HHS released a report reviewing the assumptions and methods of the Medicare Trustees’ financial projections for the Medicare program. Report: http://bit.ly/2y59x1f
  • Also on October 2, HHS Office of Inspector General (OIG) published a report quantifying savings to Medicare and its beneficiaries that are a direct result of CMS’s price substitution policy, finding that CMS lowered Part B reimbursement for 13 drugs and saved Medicare and its beneficiaries $5.4 million over one year. Report: http://bit.ly/2y5qsAM
  • Also on October 2, OIG published a report finding that the estimated cost of Medicare services related to the replacement of recalled and prematurely failed cardiac devices totaled $1.5 billion over a 10-year period ending on December 31, 2014. Summary with link to report: http://bit.ly/2y5fICd
  • On October 3, OIG released a report finding that Medicare paid $6.8 billion for lab tests in 2016. Summary with link to report: http://bit.ly/2fSaSys
  • Also on October 3, CMS released a new tool to help doctors determine whether they qualify for participation in the merit-based incentive payment system. Tool: http://bit.ly/2yb86hC
  • On October 6, Senate Finance Committee Chair Hatch (R-UT) sent a letter to CMS Administrator Verma, praising the inclusion of several requests for information as part of recent proposed rules, and asked her to publicly share proposals related to regulatory relief in the Medicare program. Letter: http://bit.ly/2ydJiFX

New Payment and Delivery System Models –

  • On October 3, CMS withdrew its proposed rule that would have established the Medicare Part B Drug Payment Model to test whether alternative payment designs will lead to a reduction in Medicare expenditures. Notice: http://bit.ly/2xWJTvy Joint statement from Senate Finance Committee Chair Hatch (R-UT), House Energy & Commerce Committee Chair Walden (R-OR), and House Ways and Means Committee Chair Brady (R-TX): http://bit.ly/2xWmbzf
  • On October 5, CMS published an updated hospital participant list for the Comprehensive Care for Joint Replacement (CJR) Model. Model documents: http://bit.ly/2fQ7ynr
  • Also on October 5, CMS announced it is withdrawing its Request for Letters of Intent for states to participate in the Medicare-Medicaid ACO Model and that it will not be moving forward with implementation of the model, citing lack of interest. Notification: http://bit.ly/2ybuszn
  • Also on October 5, CMS posted a report to Congress on the Graduate Nurse Education Demonstration, which included analysis of the growth in the number of APRNs, the growth for 4 specialties, the costs to the Medicare program as a result of the demonstration, and other items the Secretary deemed appropriate and relevant. Report: http://bit.ly/2fRlBc9

 Mental Health and Substance Abuse –

  • On October 3, Senate Finance Committee Chair Hatch (R-UT) led ten Republican Finance Committee Members in a letter to HHS Acting Secretary Wright, urging him to increase safeguards against opioid fraud. Press release: http://bit.ly/2xWeNnC Letter: http://bit.ly/2xWPW3b
  • On October 4, U.S. Government Accountability Office (GAO) published a report outlining HHS’s recommendations to prevent and treat neonatal abstinence syndrome and recommending that HHS develop a plan to implement the recommendations. Summary with link to report: http://bit.ly/2fQdQ6p
  • On October 5, Centers for Disease Control and Prevention (CDC) released data showing that over the period from 2011 to 2015, rural counties consistently had higher suicide rates than metropolitan counties. Press release: http://bit.ly/2fRzG9w

 Prescription Drugs –

  • On October 2, Food and Drug Administration (FDA) announced a new dashboard as a part of the Adverse Event Reporting System to facilitate access to reports of adverse drug reactions. Press release: http://bit.ly/2y5mXdg
  • On October 3, GAO published a report on the FDA’s expanded access programs, which allow patients with serious or life threatening illnesses access to certain drugs before full approval and require manufacturers submit data about adverse reactions. Report: http://bit.ly/2fRlCNp
  • On October 3, FDA published a blog post describing its efforts to ease the application process for investigational new treatments, including by allowing just one Institutional Review Board (IRB) member to approve the treatment. Blog post: http://bit.ly/2y4TvnK
  • On October 3, FDA released draft guidance on developing complex generic drugs. Comments are due by December 2. Draft guidance: http://bit.ly/2fSGFiP
  • On October 5, OIG released a report finding that the FDA generally spent its prescription drug user fee collections appropriately. Summary with link to report: http://bit.ly/2ybm2br
  • On October 6, FDA announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next 4 years to boost the development of products for patients with rare diseases. Press release: http://bit.ly/2y59FxG

Veterans Health –

  • On October 2, Department of Veterans Affairs (VA) announced the formation of a Veterans’ Family, Caregiver, and Survivor Federal Advisory Committee, which will advise the Secretary with a focus on gaining a better understanding of the use of VA care and benefits services, and factors that influence access, quality, and accountability for those services. Press release: http://bit.ly/2y58a2k

 Hurricanes –

  • On October 2, CMS Administrator Verma outlined CMS’ actions in support of the Hurricane Maria recovery efforts, including waivers for hospitals and other healthcare facilities, special enrollment opportunities for hurricane victims, and a healthcare provider hotline. Press release: http://go.cms.gov/2fQdk8y
  • Also on October 2, HHS announced a three-tiered strategy to shore up health care facilities impacted by Hurricane Maria in Puerto Rico. Press release: http://bit.ly/2fRoWYT
  • On October 5, HHS announced that it has activated its Emergency Prescription Assistance Program for Puerto Rico to give residents access to the critical prescription medications they need. The program pays for prescription medications for people without health insurance who are affected by disasters. Press release: http://bit.ly/2fRAnj8
  • On October 8, HHS declared public health emergencies in Alabama, Florida, Louisiana, and Mississippi due to Hurricane Nate. Press release: http://bit.ly/2ybKbi8

 Misc. –

  • On October 3, Sens. Warren (D-MA), Hatch (R-UT), Whitehouse (D-RI), Baldwin (D-WI), and Cassidy (R-LA) sent a letter to the UGAO, urging it to consider a number of key issues related to improving patient matching in the U.S. health systems as it begins a study required by the 21st Century Cures Act. Press release: http://bit.ly/2xZWyxK Letter: http://bit.ly/2xZLNv7
  • On October 3, Centers for Disease Control and Prevention (CDC) published a report finding that overweight and obesity are associated with increased risk of 13 types of cancer. These cancers account for about 40 percent of all cancers diagnosed in the United States in 2014. Press release: http://bit.ly/2fPVItl
  • On October 5, Substance Abuse and Mental Health Services Administration (SAMHSA) announced the award of $166 million over five years through its Targeted Capacity Expansion-HIV Program and its Prevention Navigator Program, which will be sued to prevent HIV among high-risk populations and to treat co-occurring behavioral health disorders and HIV. Press release: http://bit.ly/2fR4sj1
  • Also on October 5, FDA approved the first test for screening Zika virus in blood donations. Press release: http://bit.ly/2y4A6mT