General Publications June 1, 2018

Alston & Bird Healthcare Week in Review, June 1, 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 May 30, 2018, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Compliance with Statutory Program Integrity Requirements. The Office of Population Affairs (OPA), in the Office of the Assistant Secretary for Health, proposes to revise its Title X regulations (Title X of the Public Health Service Act) to ensure compliance with, and enhance implementation of, the statutory requirement that none of the funds appropriated for Title X may be used in programs where abortion is a method of family planning and related statutory requirements. In addition, OPA proposes amendments to the Title X regulations that would, among other things, clarify grantee responsibilities to provide a broad range of family planning methods; to require documented compliance with State and local laws requiring notification or the reporting of child abuse, child molestation, sexual abuse, rape, incest, intimate partner violence, and human trafficking; to provide free or low cost access to family planning services for those women who are unable to obtain employer sponsored insurance coverage for certain contraceptive services due to their employers’ religious beliefs or moral convictions; to provide for the appropriate expenditure of federal Title X funds on family planning services, rather than on lobbying or related activities; and to appropriately encourage family participation in family planning decisions, all as required by Federal law.
  • On May 31, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Waivers of the Single, Shared System Risk Evaluation and Mitigation Strategy Requirement. This guidance describes how FDA intends to consider granting a waiver of the requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that the applicant for an abbreviated new drug application and its reference listed drug use a single, shared system for a required risk evaluation and mitigation strategy with elements to assure safe use.
  • On May 31, 2018, the FDA issued guidance entitled, Development of a Shared System Evaluation and Mitigation Strategy. This draft guidance provides recommendations on the development of a shared system risk evaluation and mitigation strategy for multiple prescription drug (including biological) products. This guidance describes some of the possible benefits of a shared system REMS, and provides general principles and recommendations to assist industry with the development of these programs.
  • On June 1, 2018, Health Resources and Services Administration (HRSA) issued a final rule entitled, 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. On May 7, 2018, HHS solicited comments on further delaying the effective date of the January 5, 2017, final rule to July 1, 2019. HHS proposed this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for any additional rulemaking. After consideration of the comments received on the proposed rule, HHS is delaying the effective date of the January 5, 2017, final rule, to July 1, 2019.
  • On June 1, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a notice entitled, Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items That Require Prior Authorization as a Condition of Payment. This document announces the addition of 31 Healthcare Common Procedure Coding System (HCPCS) codes to the Required Prior Authorization List of DMEPOS items that require prior authorization as a condition of payment. Prior authorization for these codes will be implemented nationwide.

Event Notices

  • June 15, 2018: The Health Resources and Services Administration announced a public meeting of the Advisory Commission on Childhood Vaccines. The meeting agenda includes updates from other government agencies, including the Department of Justice and the FDA.
  • June 25, 2018: The Center for Medicare and Medicaid Services (CMS) announced the Annual Laboratory Public Meeting. The meeting will gather public input on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the clinical laboratory fee schedule for calendar year 2019.
  • June 25-26, 2018: The FDA announced a public symposium to discuss scientific topics related to the regulation of biologics and to highlight science conducted at the Center for Biologics Evaluation and Research. The symposium will include presentations by experts from academic institutions, government agencies, and research institutions.
  • June 26, 2018: The FDA announced a public meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss new drug application for, oxycodone extended-release capsules, submitted by Pain Therapeutics.
  • July 9, 2018: The FDA announced a public meeting on “Patient-Focused Drug Development for Chronic Pain.” The meeting will provide patients with an opportunity to present FDA their perspectives on the impacts of chronic pain, views on treatment approaches for chronic pain, and challenges or barriers to accessing treatments.
  • July 25, 2018: The CMS announced a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). The meeting will focus on obtaining the MEDCAC’s appraisal and recommendations regarding the state of evidence for procedural volume requirements, especially pertaining to surgical aortic valve replacements, trans-catheter aortic valve replacements and percutaneous coronary interventions for hospitals.
  • August 20, 2018: The CMS announced the annual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2018. The purpose of the Panel is to advise the HHS Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights as well as hospital outpatient therapeutic services supervision issues.

II. Congressional Legislation & Committee Action

U.S. Senate

  • No health care-related hearings this week.

House of Representatives

  • No health care-related hearings this week.

III. Reports, Studies, & Analyses

IV. Other Health Policy News

  • On May 31, 2018, CMS published a blog post entitled, Quality Payment Program Exceeds Year 1 Participation Goal. The post announced that 91 percent of all clinicians eligible for the Merit-based Incentive Payment System participated in the first year of the Quality Payment Program, which exceeded expectations.
Media Contact
Alex Wolfe
Communications Director

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