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 12, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients. The guidance is one of a series of guidances that provide recommendations regarding eligibility criteria for clinical trials of drugs or biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) for the treatment of cancer. Specifically, this guidance includes recommendations on the inclusion of pediatric patients (i.e., children and adolescents) in clinical trials for cancer treatments. Broadening cancer trial eligibility criteria can maximize the generalizability of trial results and the ability to understand the therapy’s benefit-risk profile across the patient population likely to use the agent in clinical practice without jeopardizing patient safety.
- On March 14, 2019, the Centers for Medicare & Medicaid Services (CMS) issued corrections on the rule entitled, Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program--Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions from the Medicare Shared Savings Program--Accountable Care Organizations--Pathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. This document corrects technical errors in the “Evaluation and Management Services” provisions that appeared in the final rule with comment period published in the Federal Register on November 23, 2018, concerning changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies to ensure that CMS’s payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute.
- On March 15, 2019, the FDA issued a guidance entitled, Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals; Guidance for Industry. This guidance outlines nonclinical studies recommended for the development of pharmaceuticals used to treat patients with severely debilitating or life-threatening hematologic disorders (SDLTHDs) and addresses comments received to the docket. This guidance is intended to streamline the development of pharmaceuticals used to treat patients with SDLTHDs, other than cancer, while protecting patients’ safety and avoiding unnecessary use of animals, in accordance with the 3R (reduce, refine, replace) principles. This guidance applies to pharmaceuticals used both to treat the active disease and to prevent the recurrence of a life-threatening or debilitating event.
- 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 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.
II. Congressional Legislation & Committee Action
- On March 14, 2019, the Senate Finance Committee held a hearing entitled, The President’s Fiscal Year 2020 Budget. HHS Secretary Alex Azar testified.
House of Representatives
- On March 12, 2019, the House Energy and Commerce Committee held a hearing entitled, The Fiscal Year 2020 HHS Budget. HHS Secretary Alex Azar testified.
- On March 12, 2019, The House Committee on Oversight and Reform held a hearing entitled, Examining the Public Health Risks of Carcinogens in Consumer Products. Witnesses included: Ann McTiernan, MD, Fred Hutchinson Cancer Research Center; Scott Faber, Vice President of Government Affairs, Environmental Working Group; and Marvin Salter, Son Deceased Ovarian Cancer Patient.
- On March 13, 2019, The House Energy and Commerce Subcommittee on Health held a hearing entitled, Lowering the Cost of Prescription Drugs: Reducing Barriers to Market Competition. The witnesses included: Lou Kennedy CEO and Owner, Nephron Pharmaceuticals; Anthony Barrueta, Senior Vice President, Government Relations, Kaiser Permanente; Michael Carrier, Professor, Rutgers Law School; Kurt Karst, Director, Hyman, Phelps & McNamara; Jeff Kushan, Partner, Sidley Austin; Marc Boutin, CEO, National Health Council; and Chester Davis, President and CEO, Association for Accessible Medicines.
- March 13, 2019, the House Appropriations Committee held a hearing entitled, Department of Health and Human Services Budget Request for FY 2020. HHS Secretary Alex Azar testified.
III. Reports, Studies, & Analyses
- On March 12, 2019, the Office of Inspector General at HHS issued a report entitled, Summary Report for Office of Inspector General Penetration Testing of Eight HHS Operating Division Networks. The report summarized testing to determine how well HHS systems are protected from cyberattacks. The OIG determined that more work is needed to detect and prevent cyberattacks and provided “broad” recommendations to HHS.
IV. Other Health Policy News
- On March 12, 2019, HHS released the fiscal year 2020 HHS Budget. The document is available here.
- On March 15, 2019, the Medicare Payment Advisory Commission (MedPAC) and the Medicaid and CHIP Payment and Access Commission (MACPAC) issued their 2019 March reports to Congress. The MedPAC report is available here. The MACPAC report is available here.