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 March 18, 2019, the Agency for Healthcare Research and Quality (AHRQ) issued a request for information entitled, Supplemental Evidence and Data Request on Nonopioid Pharmacologic Treatments for Chronic Pain. The AHRQ is seeking scientific information from the public to inform its review of nonopioid pharmacologic treatments for chronic pain. The AHRQ would like access to published and unpublished scientific information to improve its review process.
- On March 19, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Pediatric Human Immunodeficiency Virus Infection: Drug Product Development for Treatment. The purpose of this guidance is to provide general recommendations on the development of antiretroviral drug products for the treatment of human immunodeficiency virus (HIV) infection in pediatric patients. The guidance addresses when to initiate pediatric formulation development and begin pediatric studies and offers approaches for enrollment of subjects into pediatric studies to help facilitate drug product development. This guidance incorporates the comments received for and finalizes the draft guidance for industry “Pediatric HIV Infection: Drug Development for Treatment” issued on May 14, 2018.
- On March 21, 2019, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a final rule entitled, Medicaid; Revisions to State Medicaid Fraud Control Unit Rules. This final rule amends the regulation governing State Medicaid Fraud Control Units (MFCUs or Units). The rule incorporates statutory changes affecting the Units as well as policy and practice changes that have occurred since the regulation was initially issued in 1978. These changes include a recognition of OIG’s delegated authority; Unit authority, functions, and responsibilities; disallowances; and issues related to organization, prosecutorial authority, staffing, recertification, and the Units’ relationship with Medicaid agencies. The rule is designed to assist the MFCUs in understanding their authorities and responsibilities under the grant program, clarify the flexibilities the MFCUs have to operate their programs, and reduce administrative burden, where appropriate, by eliminating duplicative and unnecessary reporting requirements.
- On March 22, 2019, the FDA issued draft guidance entitled, Rare Diseases: Natural History Studies for Drug Development. The FDA is publishing this draft guidance to help inform the design and implementation of natural history studies that can be used to support the development of safe and effective drugs and biological products for rare diseases. A natural history study collects information about the natural history of a disease in the absence of an intervention, from the disease’s onset until either its resolution or the individual’s death. Although knowledge of a disease’s natural history can benefit drug development for many disorders and conditions, natural history information is usually not available or is incomplete for most rare diseases; therefore, natural history information is particularly needed for these diseases.
- March 22, 2019: The FDA announced a meeting of the Vaccines and Related Biological Products Advisory Committee. The Committee will discuss and make recommendations on the H3N2 seasonal influenza strain. The World Health Organization recommended the strain for inclusion in the 2019-2020 seasonal influenza vaccines.
- April 2-3, 2019: The Health Resources and Service Administration (HRSA) announced a meeting of the National Advisory Council on the National Health Service Corps (NHSC). No agenda has been posted but the Council is expected to make recommendations on the NHSC.
- 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 systems’ past performance, future targets, emerging industry needs and technology initiatives.
- April 10, 2019: CMS announced a public meeting of the Advisory Panel on Outreach and Education (APOE). APOE advises and makes recommendations to the HHS Secretary and CMS Administrator concerning optimal strategies for: (1) developing and implementing education and outreach programs for individuals enrolled in or eligible for the Health Insurance Marketplace, Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP); (2) enhancing the federal government’s effectiveness in informing stakeholders on education and outreach programs; (3) expanding outreach to vulnerable and underserved communities; (4) assembling and sharing “best practices”; (5) building and leveraging existing infrastructures for information counseling and assistance; and (6) drawing the program link between outreach and education and supporting the overarching goal of improved access to quality care.
- April 29, 2019: The FDA announced a public meeting entitled, Perspectives on the Impact of Rare Diseases: Bridging the Commonalities. The meeting is intended to obtain patients’ and caregivers’ perspectives on impacts of rare diseases on daily life and to asses commonalities that may help the FDA and medical product developers further understand and advance the development of treatments for rare diseases.
- There were no health-related hearings this week.
House of Representatives
- There were no health-related hearings this week.
III. Reports, Studies, & Analyses
- On March 21, 2019, the Government Accountability Office (GAO) issued a report entitled, Private Insurance: Enrollment Remains Concentrated Among Few Issuers, Including in Exchanges. The GAO found enrollment in private health insurance plans continued to be concentrated among a few insurers in 2015 and 2016. In the overall market, (i.e., employer and individual insurance) the three largest insurers held 80 percent of the market.
IV. Other Health Policy News
- On March 19, 2019, the Congressional Budget Office (CBO) issued a working paper entitled, Prices for and Spending on Specialty Drugs in Medicare Part D and Medicaid: An In-Depth Analysis. The working paper examined the prices paid for specialty drugs and spending on those drugs in Medicare Part D and Medicaid from 2010 – 2015. The CBO found that Medicare Part D net spending rose from $8.7 billion in 2010 to $32.8 billion in 2015. Medicaid’s spending doubled over the same period and reached $9.9 billion in 2015.