I. Regulations, Notices, & Guidance
- On April 3, 2017, the National Institutes of Health (NIH) issued a notice entitled, Prospective Grant of Start-up Exclusive Evaluation Option Patent License: “The development and use of diazeniumdiolated and hybrid diazeniumdiolated compounds for the treatment of ovarian cancer in humans.” The notice announces that the National Cancer Institute within the NIH is contemplating the grant of a Start-up Exclusive Evaluation Option License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Tar Meta Biosciences, Inc. (TarMeta) located in King of Prussia, PA, USA. Comments are due by April 19, 2017.
- On April 3, 2017, the NIH issued a notice entitled, Prospective Grant of Exclusive Patent License: Development and commercialization of Peptides Promoting Lipid Efflux for the treatment of Hypertriglyceridemia, with or without concomitant metabolic syndrome. The notice announces that the National Heart, Lung, and Blood Institute within the NIH is contemplating the grant of an exclusive patent license to commercialize the invention(s) embodied in the intellectual property estate stated in the Summary Information section of this notice to Corvidia Therapeutics Inc. (Corvidia) located in Waltham, MA and incorporated under the laws of Delaware. Comments are due by April 19, 2017.
- On April 3, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a notice and call letter entitled, Advance Notice of Methodological Changes for Calendar Year (CY) 2018 for Medicare Advantage (MA) Capitation Rates, Part C and Part D Payment Policies and 2018 Call Letter. The notice releases the final updates to the Medicare Advantage (MA) and Part D programs through the 2018 Rate Announcement and Call Letter. In addition to finalizing rates and program rules in the 2018 Rate Announcement and Call Letter, CMS is releasing a Request for Information (RFI) to welcome continued feedback on MA and Part D. According to CMS, they hope to use transparency, flexibility, program simplification and innovation to transform the MA and Part D programs. The RFI requests recommendations from stakeholders and the public for regulatory, sub-regulatory, policy, practice, and procedural changes to achieve these goals. Responses to the RFI are due by April 24, 2017.
- On April 4, 2017, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Announcement of Requirements and Registration for Million Hearts® Hypertension Control Challenge. The notice announces the launch of the Million Hearts Hypertension Control Challenge. According to the CDC, the Million Hearts is a national initiative to prevent one million heart attacks and strokes by 2022.
- On April 5, 2017, the Office of Management and Budget (OMB) received a proposed rule from the Department of Health and Human Services (HHS) entitled, CY 2018 Changes to the End-Stage Renal Disease (ESRD) Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS). The proposed rule would update the bundled payment system for ESRD facilities by January 1, 2018. The rule would also update the quality incentives in the ESRD program and implement changes to the DMEPOS competitive bidding program.
- On April 6, 2017, CMS issued a notice entitled, Ending Special Enrollment Periods for Coverage during Calendar Year 2016. The notice announces that as of April 1, 2017, CMS will no longer accept new requests for a Special Enrollment Period (SEP) that would enable consumers to enroll in a Qualified Health Plan (QHP) with 2016 coverage effective dates through the Federally-facilitated Marketplace, Federally-facilitated Marketplaces where States perform plan management functions, or State-based Marketplace using the Federal Platform.
- April 12, 2017: the Food and Drug Administration (FDA) announced a public workshop regarding new developments and scientific issues related to antibody mediated rejection (AMR) in kidney transplantation. The public workshop is intended to provide information for and gain perspective from individuals, industry, health care professionals, researchers, public health organizations, patients, patient care providers, and other interested persons on various aspects of clinical development of medical products for prophylaxis and/or treatment of AMR in kidney transplant recipients, including clinical trial design and endpoints.
- April 13, 2017: The FDA announced a public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The committee will discuss the development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections; examples of such drugs include those that are only active against Pseudomonas aeruginosa or Acinetobacter baumannii.
- May 3 – 5, 2017: The FDA Cincinnati District, in co-sponsorship with Xavier University, announced a public conference entitled, FDA/Xavier University Medical Device Conference (MedCon). The 3-day public conference includes presentations from key FDA officials and industry experts with small group break-out sessions. The conference is intended for companies of all sizes and employees at all levels.
II. Congressional Legislation & Committee ActionU.S. Senate
- On April 4, 2017, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing entitled, FDA User Fee Agreements: Improving Medical Product Regulation and Innovation for Patients Part II. The witnesses included Kay Holcombe, Senior Vice President for Science Policy at the Biotechnology Innovation Organization; David Gaugh, Senior Vice President of Sciences and Regulatory Affairs at the Association for Accessible Medicines; Scott Whitaker, President and CEO of the Advanced Medical Technology Association; and Cynthia Bens, Vice President of Public Policy at the Alliance for Aging Research.
- On April 5, 2017, the Senate HELP Committee held a hearing on the nomination of Scott Gottlieb to be Commissioner of the FDA.
- On April 5, 2017, the House Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee held a hearing entitled, Opioid Abuse Crisis Response. The witnesses included Barbra Cimaglio, Deputy Commissioner, Vermont Department of Health; Bill Guy Advocate, Parents Helping Parents; Nancy Hale, President and CEO, Operation UNITE; and Rosalie Liccardo Pacula ,Senior Economist and Co-Director, Drug Policy Research Center, RAND Corporation.
Upcoming Congressional Floor and Committee Action
- The Senate has adjourned and will reconvene on Monday, April 24, 2017.
- The House has adjourned and will reconvene on Tuesday, April 25, 2017.
- On April 4, 2017, the Congressional Budget Office (CBO) released a working paper entitled, An Analysis of Private-Sector Prices for Hospital Admissions. The paper compares the hospital payment rates of three larger insurers’ commercial plans and Medicare Advantage plans with Medicare’s fee-for-service rates. It also examines the variation of those rates across and within markets.
IV. Other Health Policy News
- On April 3, 2017, CMS released a fact sheet entitled, 2018 Medicare Advantage and Part D Rate Announcement and Call Letter, and Request for Information. The fact sheet outlines the finalized updates to the methodologies used to pay MA plans and Part D sponsors.
- On April 4, 2017, CMS released a question and answer document entitled, Home Health Pre-Claim Review (PCR) Demonstration Pause Questions and Answers. The document answers questions related to the pausing of the Pre-Claim Review Demonstration.
- On April 6, 2017, CBO released Answers to Questions for the Record Following a Hearing on the Budget and Economic Outlook for 2017 to 2027 Conducted by the Senate Committee on the Budget. The Senate Budget Committee convened a hearing at which Director Keith Hall testified about CBO’s report The Budget and Economic Outlook: 2017 to 2027. This document provides CBO’s answers to questions submitted for the record.
- On April 6, 2017, CMS announced the participants for two of the tracks, the Assistance and Alignment Tracks, of the Accountable Health CommunitiesA list of the Assistance and Alignment Tracks bridge organizations in the Accountable Health Communities Model can be found here.
V. ACA Repeal News
- On April 6, 2017, the House Rules Committee reconvened a meeting regarding legislation to repeal and replace the Affordable Care Act (ACA), entitled H.R. 1628, the “American Health Care Act” (AHCA). The Rules Committee adopted a Rule (by a vote of 9-2) that provides for further consideration of the AHCA with an amendment from Representatives Gary Palmer (R-AL) and David Schweikert (R-AZ)being self-executed into the legislation. The amendment would allocate $15 billion from the Patient and State Stability Fund from 2018 to 2026 to create a federal “invisible risk sharing program.” The amendment can be found here.
- House Rules Committee Chairman Pete Sessions (R-TX) suggested that the House intends to vote on the AHCA legislation upon its return from Easter Recess.