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 April 10, 2019, the Department of Health and Human Services (HHS) issued a final rule entitled, Privacy Act; Implementation. HHS is issuing this final rule to make effective the exemptions that HHS proposed for certain records covered in a new Privacy Act system of records, System No. 09-90-1701, HHS Insider Threat Program Records.
- On April 11, 2019, the Food and Drug Administration (FDA) issued a final rule entitled, Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. The FDA is issuing this final action establishing that certain active ingredients used in nonprescription (also known as over-the-counter (OTC)) consumer antiseptic products intended for use without water (referred to throughout as consumer antiseptic rubs or consumer rubs) are not eligible for evaluation under the OTC Drug Review for use in consumer antiseptic rubs. Drug products containing these ineligible active ingredients will require approval under a new drug application (NDA) or abbreviated new drug application (ANDA) prior to marketing. FDA is issuing this final action after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC), public comments on the Agency’s notices of proposed rulemaking, and all data and information on OTC consumer antiseptic rub products that have come to the Agency’s attention. This final action finalizes the 1994 tentative final monograph (TFM) for OTC consumer antiseptic rub drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM), as amended by the proposed rule published in the Federal Register (FR) of June 30, 2016 (2016 Consumer Antiseptic Rub proposed rule).
- On April 12, 2019, the Centers for Disease Control and Prevention (CDC) issued a request for information entitled, The National Healthcare Safety Network’s Proposed Requirement for Submission of Billing Codes as Part of Surgical Site Infection (SSI) Event Reporting. The CDC announced the opening of a docket to obtain information of International Classification of Diseases, 10th Revision, Procedural Classification System (ICD-10-PCS) or Current Procedures Terminology (CPT) Codes (collectively, Billing Codes) when reporting data to the National Healthcare Safety Network’s NHSN) Surgical Site Infection (SSI) Module of the Patient Safety Component. CDC is opening this docket to provide the opportunity to identify challenges for facilities to include ICD-10-PCS or CPT Codes when reporting SSI data to the NHSN, which is proposed to begin in 2021.
Event Notices
- 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.
- May 9 – 10, 2019: The FDA announced a meeting of the Pain Management Best Practices Inter-Agency Task Force. The Task Force will review clinical guidelines and identify gaps and/or inconsistencies for best practices for pain management.
- May 13, 2019: The FDA announced a public meeting entitled, The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products. The hearing is set to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products.
II. Congressional Legislation & Committee Action
U.S. Senate
- On April 9, 2019, the Senate Finance Committee held a hearing entitled, Drug Pricing in America: A Prescription for Change, Part III. Witnesses included: Steve Miller, Executive Vice President, Cigna Corporation; Derica Rice, Executive Vice President, CVS Health and CVS Caremark; William Fleming, Pharm.D., Segment President, Humana Inc.; John Prince, Chief Executive Officer, OptumRx; and Mike Kolar, Interim President & CEO, Prime Therapeutics LLC.
House of Representatives
- On April 9, 2019, the House Ways and Means Committee held a markup entitled, Markup of Prescription Drug Pricing Legislation. The legislation passed by a voice vote.
- On April 10, 2019, House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Priced Out of A Lifesaving Drug: Getting Answers on the Rising Cost of Insulin. Witnesses present included: Mike Mason, Senior Vice President, Eli Lilly; Doug Langa, Executive Vice President, Novo Nordisk Inc.; Kathleen Tregoning, Executive Vice President for External Affairs, Sanofi; Thomas Moriarty, Executive Vice President, CVS Health; Amy Bricker, Senior Vice President, Express Scripts; and Sumit Dutta, Chief Medical Officer, OptumRx.
III. Reports, Studies, & Analyses
- On April 8, 2019, the Center for American Progress issued a report entitled, Excess Administrative Costs Burden the U.S. Health Care System. The analysis found that the United States spends more on administrative costs than other countries. In 2016, administrative costs total 8.3 percent of all spending, which was significantly higher than other counties. The second highest administrative spender was France at approximately 5.7 percent.
IV. Other Health Policy News
- On April 11 and 12, 2019, the Medicaid and CHIP Payment and Access Commission held their April meeting. The agenda is available here.