General Publications November 30, 2018

Alston & Bird Healthcare Week in Review, November 30, 2018

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health policy news.

I. Regulations, Notices, & Guidance

  • On November 26, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out of Pocket Expenses. This proposed rule would amend the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to support health and drug plans’ negotiation for lower drug prices and reduce out-of-pocket costs for Part C and D enrollees.
  • On November 26, 2018, the Department of Health and Human Services (HHS) issued a notice entitled, Solicitation for Written Comments on Proposed Objectives for Healthy People 2030. The Office of Disease Prevention and Health Promotion (ODPHP) is soliciting written comments on the proposed Healthy People 2030 objectives, including proposed core, developmental, and research objectives. The public is also invited to propose new objectives to be considered for inclusion in Healthy People 2030. ODPHP manages the Healthy People initiative, which provides science-based, 10-year national objectives for promoting health and preventing disease. Every 10 years, through the Healthy People initiative, HHS leverages scientific insights and lessons from the past decade along with new knowledge of current data, trends, and innovations to develop the next iteration of national health promotion and disease prevention objectives. For four decades, Healthy People has set and monitored national health objectives to meet a broad range of health needs. The proposed objectives for Healthy People 2030 represent a streamlined set of objectives, representing important public health issues facing our nation.
  • On November 29, 2018, the Food and Drug Administration (FDA) issued draft guidance entitled, Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. The FDA is announcing the availability of the draft guidance for industry and FDA staff entitled "Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use." This draft guidance document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) that are for prescription point-of-care use. This draft guidance is not final nor is it in effect at this time.
  • On November 29, 2018, the Department of Health and Human Services (HHS) issued a proposed rule entitled, 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the “340B Drug Pricing Program” or the “340B Program.” HHS published a final rule on January 5, 2017, that set forth the calculation of the 340B ceiling price and application of civil monetary penalties. On June 5, 2018, HHS published a final rule that delayed the effective date of the 340B ceiling price and civil monetary rule until July 1, 2019, to consider alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. On November 2, 2018, HHS issued a proposed rule to solicit comments to change the effective date from July 1, 2019, to January 1, 2019, and to cease any further delay of the rule. HHS proposed this action because it determined that the January 5, 2017, final rule has been subject to extensive public comment, and had been delayed several times. HHS has considered the full range of comments on the substantive issues in the January 5, 2017, final rule. After consideration of the comments received on the effective date of the proposed rule, HHS is changing the effective date of the January 5, 2017, final rule, to January 1, 2019.

Event Notices   

  • December 5, 2018: The FDA announced a public hearing to discuss its efforts to eliminate youth electronic cigarette use as well as other tobacco use, with a focus on the potential role of drug therapies to support youth e-cigarette cessation and the issues impacting the development of such therapies.
  • December 5-6, 2018: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Board of Scientific Counselors, Office of Infectious Diseases (BSC OID).  The BSC OID will hear updates from the infectious disease national centers and discuss recent outbreaks and affected populations.
  • December 11, 2018: The FDA announced a public meeting entitled, Drug Development Tool Process under the 21st Century Cures Act and PDUFA VI. The meeting is intended to fulfill commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) and the 21st Century Cures Act (Cures Act) by soliciting comments on Drug Development Tool Qualification at FDA related to the qualification process under section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act); discussing taxonomy for biomarkers and related concepts used in drug development; and planning activities to define a framework with appropriate standards and scientific approaches to support qualification for a specified context of use.
  • April 10, 2019: The FDA announced a public meeting entitled, Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards. The purpose of the meeting is to fulfill FDA’s commitment to seek stakeholder input related to data standards and the electronic submission system’s past performance, future targets, emerging industry needs and technology initiatives.

II. Congressional Legislation & Committee Action

U.S. Senate

  • On November 28, 2018, the Senate Committee on Health, Education, Labor and Pensions held a hearing entitled, Reducing Health Care Costs: Improving Affordability Through Innovation. Witnesses included: Lee Gross, M.D., President, Docs 4 Patient Care Foundation, Epiphany Health Direct Primary Care; Cheryl DeMars, President and Chief Executive Officer, The Alliance; Dow Constantine, Executive of King County, Seattle Washington; and Jonathan Perlin, M.D., Ph.D., President, Clinical Services and Chief Medical Officer, HCA Healthcare.

House of Representatives

  • There were no health-related hearings this week.

III. Reports, Studies, & Analyses

  • On November 28, 2018, the Kaiser Family Foundation released polling data related to health care issues. The poll found that the majority of the public wants the new Democratic majority in the House of Representatives to work with Republicans to conduct oversight on President Trump’s administrative actions on health care policies. However, most Americans are not confident Congress will be able to work on bipartisan legislation to address health care issues. The poll is available here.

IV. Other Health Policy News

  • On November 29, 2018, the Office of the National Coordinator for Health Information Technology (ONC) issued a document entitled, Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and electronic health records (EHRs). The document provides strategies and recommendations for the following: (1) reduce the effort and time required to record information in EHRs for health care providers during care delivery; (2) reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and health care organizations; and (3) improve the functionalist and intuitiveness of EHRs. The ONC is requesting comments by January 28, 2019.
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