General Publications December 14, 2018

Alston & Bird Healthcare Week in Review, December 14, 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 December 11, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Definition of the Term Biological Product. FDA is proposing to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), and to provide its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide.” Under that interpretation, the term protein would mean any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. A chemically synthesized polypeptide would mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids but less than 100 amino acids in size. This proposed rule is intended to clarify the statutory framework under which such products are regulated.
  • On December 12, 2018, the FDA issued guidance entitled, Biosimilars: Questions and Answers on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry; Availability. The FDA is announcing the availability of a final guidance for industry entitled "Questions and Answers on Biosimilar Development and the BPCI Act." The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA’s interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance document revises the final guidance document entitled "Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009" issued April 28, 2015.
  • On December 13, 2018, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Request for Information on Modifying HIPAA Rules to Improve Coordinated Care. The Office for Civil Rights (OCR) is issuing this Request for Information (RFI) to assist OCR in identifying provisions of the Health Insurance Portability and Accountability Act privacy and security regulations that may impede the transformation to value-based health care or that limit or discourage coordinated care among individuals and covered entities (including hospitals, physicians, and other providers, payors, and insurers), without meaningfully contributing to the protection of the privacy or security of individuals’ protected health information. This RFI requests information on whether and how the rules could be revised to promote these goals, while preserving and protecting the privacy and security of such information and individuals’ rights with respect to it.
  • On December 13, 2018, the FDA issued a final rule entitled, Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures. The FDA is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also making additional changes unrelated to the FDASIA requirements, to update its regulations governing the classification and reclassification of medical devices. FDA is taking this action to codify the procedures and criteria that apply to the classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.

Event Notices   

  • January 9, 2019: The Health Resources and Services Administration (HRSA) announced a public meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. The meeting will cover the annual report describing the activities of the Committee and recommendations for training programs in oral health and dentistry.
  • 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

  • There were no health-related hearings this week.

House of Representatives

III. Reports, Studies, & Analyses

  • On December 13, 2018, Health Affairs issued a report entitled, Cash Flow Dynamics and Family Health Care Spending: Evidence From Banking Data. The report found that consumers increase health care spending by 60 percent in the week after receiving a tax refund, and the majority of the payments are made in person while receiving the care the same day. According to the authors, the findings suggest that many consumers make decisions about when to pay for and receive health care based on whether they have cash on hand.

IV. Other Health Policy News

  • On December 13-14, 2018, the Medicaid and CHIP Payment and Access Commission (MACPAC) held their December meeting. The agenda is available here.
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