I. Regulations, Notices, & Guidance
- On February 21, 2017, the National Institutes of Health (NIH) issued a notice entitled, Prospective Grant of Exclusive Patent License: Development of a Gene Signature Predictive of Hepatocellular Carcinoma (HCC) Patient Response to Transcatheter Arterial Chemoembolization (TACE). The notice announces that the NIH is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to 3D Medicines (“3DMed”) located in Shanghai, China. Comments are due by March 9, 2017.
- On February 22, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—October through December 2016. The quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2016, relating to the Medicare and Medicaid programs and other programs administered by CMS.
- On February 23, 2017, CMS issued a proposed notice entitled, Medicare and Medicaid Programs: Application from the Center for Improvement in Healthcare Quality for Continued Approval of its Hospital Accreditation Program. The proposed notice acknowledges the receipt of an application from the Center for Improvement in Healthcare Quality (CIHQ) for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs. Comments are due by March 27, 2017.
- On February 23, 2017, CMS issued a notice entitled, Medicare Program; Public Meetings in Calendar Year 2017 for All New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding and Payment Determinations. The notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2017 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS.
- On February 24, 2017, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Draft Chapter: Analysis of Carbon Nanotubes and Nanofibers on Filters by Transmission Electron Microscopy; Request for Comments. The CDC announced the availability of a draft chapter to be published in the NIOSH Manual of Analytical Methods entitled, “Analysis of Carbon Nanotubes and Nanofibers on Filters by Transmission Electron Microscopy,” for public comment. The document and instructions for submitting comments can be found at regulations.gov. Comments are due by April 28, 2017.
- On February 24, 2017, the NIH issued a notice entitled, Prospective Grant of Exclusive Patent License: The Development of an Anti-mesothelin Recombinant Immunotoxin (RIT) for the Treatment of Human Cancers. The notice announces that the NIH, is contemplating the grant of an Exclusive Patent License to Selecta Biosciences (“Selecta”) located in Watertown, Massachusetts to practice the inventions embodied in the patent applications listed in the Supplementary Information section of the notice. Comments are due by March 14, 2017.
- March 20 – 21, 2017: The Department of Health and Human Services (HHS) announced a meeting of the Substance Abuse and Mental Health Services Administration’s (SAMHSA) Center for Substance Abuse Prevention (CSAP) Drug Testing Advisory Board (DTAB). The Board will meet in open session on March 20, 2017, from 9:00am to 2:00pm, to provide updates on the Mandatory Guidelines for Federal Workplace Drug Testing Programs, provide data on hair testing programs currently in use in the private sector, research data on marijuana edibles, and the most current data from Quest Diagnostics Drug Testing Index. The board will meet in closed session on March 20, 2017, from 2:00pm to 5:00pm EDT and on March 21, 2017, from 9:00am to 2:00pm EDT to hear about current confidential practices in the hair testing industry, and to discuss proposals for the Oral Fluid Mandatory Guidelines for Federal Workplace Drug Testing Programs.
- March 22, 2017: CMS announced a meeting of the Advisory Panel on Outreach and Education (APOE). The APOE will discuss Affordable Care Act (ACA) initiatives.
II. Congressional Legislation & Committee ActionU.S. Senate
- The Senate has adjourned until February 27, 2017.
- The House has adjourned until February 27, 2017.
- There are currently no healthcare-related hearings scheduled for next week.
- On February 28, 2017, the House Judiciary Committee is holding a hearing entitled, Health Care Legislation/Trump’s Financial Documents Inquiry. There will be a markup of H.R.372, the "Competitive Health Insurance Reform Act of 2017"; H.R.1215, the "Protecting Access to Care Act of 2017"; and H.Res.111, Resolution of inquiry directing the attorney general to transmit certain documents to the House of Representatives relating to the financial practices of the president. The hearing will take place at 10:00 a.m. in 2141 Rayburn.
- On March 1, 2017, the House Education and the Workforce Committee will hold a hearing on "Legislative Proposals to Improve Health Care Coverage and Provide Lower Costs for Families," including H.R.1101, the "Small Business Health Fairness Act"; the "Self-Insurance Protection Act"; and the "Preserving Employee Wellness Programs Act." The hearing will take place at 10:00 a.m. in 2175 Rayburn.
- On March 2, 2017, the House Energy and Commerce Health Subcommittee will hold a hearing entitled, FDA Generic Drug/Biosimilar User Fee Programs. The hearing will take place at 10:00 a.m. in 2123 Rayburn. The witnesses are TBD.
III. Reports, Studies, & Analyses
IV. Other Health Policy News
- On February 17, 2017, CMS issued a draft bulletin entitled, Revised Timing of Submission and Posting of Rate Filing Justifications for the 2017 Filing Year for Single Risk Pool Coverage; Revised Timing of Submission for Qualified Health Plan Certification Application. On December 16, 2016, CMS issued a final Unified Rate Review Bulletin: Timing of Submission and Posting of Rate Filing Justifications for the 2017 Filing Year for Single Risk Pool Coverage, as well as the final 2018 Letter to Issuers. CMS is releasing this draft bulletin for comment on the proposed revised uniform timeline for submission and public release of information about rate filings for single risk pool coverage. Comments are due by March 7, 2017.
- On February 17, 2017, CMS issued an addendum to the 2018 Letter to Issuers in the Federally-facilitated Marketplaces. The Addendum to the 2018 Letter to Issuers changes the dates for the qualified health place (QHP) certification timeline by replacing Table 1.1 Timeline for QHP Certification in the FFMs on pages 7-8 of the 2018 Letter to Issuers with the below: Table 1.1(b) Revised Timeline for QHP Certification in the FFMs. The dates in Table 1.1(b) also supersede all other references to corresponding dates within the text of the 2018 Letter to Issuers, as well as any applicable guidance. All other parts of the 2018 Letter to Issuers remain unchanged by this document.
- On February 23, 2017, CMS issued a Market Saturation and Utilization Data Tool. The data tool was formerly called the Moratoria Provider Services and Utilization Data Tool. The data tool includes interactive maps and a dataset that shows national-, state-, and county-level provider services and utilization data for selected health service areas. Market saturation, in the present context, refers to the density of providers of a particular service within a defined geographic area relative to the number of the beneficiaries receiving that service in the area.
- On February 23, 2017, CMS issued a bulletin entitled, Extended Transition to Affordable Care Act-Compliant Policies. The bulletin announces that CMS will extend their transitional policy to policy years beginning on or before October 1, 2018, provided that all such policies end by December 31, 2018. Specifically, States may permit issuers that have renewed policies under the transitional policy continually since 20145 to renew such coverage for a policy year starting on or before October 1, 2018; however, any policies renewed under this transitional policy must not extend past December 31, 2018.
V. ACA Repeal News
- On February 23, 2017, House Energy & Commerce health subcommittee Chairman Michael Burgess (R-TX) refused to set a hard deadline for when the Affordable Care Act will be scrapped, speaking at the Conservative Political Action Conference.
- On February 24, 2017, a draft GOP bill to repeal the ACA was leaked. Note that the measure is dated February 10, 2017.