Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
I. Regulations, Notices, & Guidance
- On July 25, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff. This guidance document provides recommendations for 510(k) submissions for metal expandable biliary stents and their associated delivery systems. These devices are intended to provide luminal patency of the biliary tree for palliation of malignant strictures. FDA updated this guidance to reflect current review practices.
- On July 26, 2019, FDA issued notice of guidance entitled, Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention. The purpose of this guidance is to assist sponsors in the clinical development of drugs for the prevention of delayed graft function (DGF) in kidney transplantation. This guidance finalizes the draft guidance of the same name issued March 23, 2017.
- On July 26, 2019, FDA issued notice entitled, Generic Drug User Fee Rates for Fiscal Year 2020. The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes FDA to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2020 rates for GDUFA II fees.
Event Notices
- August 1, 2019: Department of Health and Human Services (HHS) announced a public meeting entitled, Advisory Committee on Heritable Disorders in Newborns and Children. The purpose of this meeting is to solicit public comments on the condition nomination, evidence review, and decision-making processes. The Committee can accommodate oral comments made in person or via the telephone.
- August 6 and August 7, 2019: HHS announced a public meeting entitled, National Committee on Vital and Health Statistics. The goal of this expert roundtable meeting is to identify research questions to inform evaluation of the benefit and cost of transition from International Classification of Diseases-10 (ICD-10) to ICD-11 for mortality and morbidity. Specific meeting objectives include: developing a shared understanding of lessons from the ICD-10 planning process/transition and the differences between ICD-10 and ICD-11; reaching consensus on the research questions to be answered to inform evaluation of cost and benefit of transition from ICD-10 to ICD-11 for mortality and morbidity—and to identify impacts of not moving to ICD-11 for morbidity; and identifying key topics and messages to communicate to the industry to foster early stakeholder engagement and preparation for the transition to ICD-11.
- August 21, 2019: HHS Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Center for Substance Abuse Prevention. The meeting will include the discussion of the substance use prevention workforce, as well as address marijuana and HIV. The meeting will also include updates on Center for Substance Abuse Prevention (CSAP) program developments.
II. Congressional Legislation & Committee Action
U.S. Senate
- On July 25, 2019, the Senate Finance Committee held a hearing entitled, Open Executive Session to Consider an Original Bill Entitled The Prescription Drug Pricing Reduction Act of 2019. During the hearing, the Committee considered the Prescription Drug Pricing Reduction Act of 2019 (PDPRA). As described in the Chairman’s Mark released on July 23, the bill is intended to restructure payment for prescription drugs under Medicare Part B and Part D as well as make changes to prescription drug aspects of Medicaid. The Modified Chairman’s Mark was reported favorably to the Senate floor by a vote of 19-9.
House of Representatives
- On July 24, 2019, the House voted on and passed four pieces of health care legislation. The bills include H.R. 776, the Emergency Medical Services for Children Program Reauthorization Act of 2019; H.R. 2035, the Lifespan Respite Care Reauthorization Act of 2019; H.R. 1058, the Autism CARES Act of 2019; and H.R. 2507, the Newborn Screening Saves Lives Reauthorization Act of 2019.
- On July 24, 2019, the House Committee on Veterans’ Affairs held a hearing entitled, True Transparency? Assessing Wait Times Five Years After Phoenix. Witnesses present included: Dr. Debra A. Draper, Director, Health Care Team, U.S. Government Accountability Office (GAO); Dr. Teresa Boyd, Assistant Deputy Under Secretary for Health for Clinical Operations, Veterans Health Administration (VHA); Dr. Susan Kirsh, Acting Assistant Deputy Under Secretary for Health for Access to Care, VHA; Dr. Clinton Greenstone, Deputy Executive Director for Clinical Integrity, VHA Office of Community Care; and the Honorable Kenneth W. Kizer, MD, MPH, Chief Healthcare Transformation Officer & Senior Executive Vice President, Atlas Research, Inc.
- On July 25, 2019, the House Committee on Veterans’ Affairs Technology Modernization Subcommittee held a hearing entitled, VistA Transition: Assessing the Future of an Electronic Health Record Pioneer. Witnesses present included: Dr. Paul Tibbets, Executive Director, Office of Technical Integration, Office of Information and Technology, Department of Veterans’ Affairs; Charles Hume, Acting Assistant Deputy Under Secretary for Health for Office of Health Informatics, VHA; Dr. Thomas O’Toole, Senior Medical Advisor, Office of the Assistant Under Secretary for Health for Clinical Operations, VHA; John Short, Chief Technology and Integration Officer, Office of Electronic Health Record Modernization, Department of Veterans’ Affairs; and Carol Harris, Director, Information Technology Acquisition Management, GAO.
III. Reports, Studies, & Analyses
- On July 22, 2019, Kaiser Family Foundation released a study entitled, A Look at People Who Have Persistently High Spending on Health Care. This analysis looks at the amounts and types of health spending for people with employer-based health insurance who have continuing high health care spending. To do this, the authors used the IBM MarketScan Commercial Claims and Encounters Database (MarketScan), which has clinical and enrollment information for millions of workers and their dependents. They looked at the spending for a subset of enrollees with three consecutive years of coverage (2015-2017) and then identified those who were in the top five percent of spenders in each of the three years, which were refer to as “people with persistently high spending.” Overall, these people with persistently high spending comprised only 1.3 percent of the continuously covered subgroup but accounted for 19.5 percent of total spending in the final year of the period (2017).
- On July 22, 2019, the Office of Inspector General (OIG) released a report entitled, July 2019 Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: OIG’s Top Recommendations. The Solutions to Reduce Fraud, Waste, and Abuse in HHS Programs: OIG's Top Recommendationsis an annual publication of the OIG. In this edition, OIG focuses on the top 25 unimplemented recommendations that, in OIG's view, would most positively affect HHS programs in terms of cost savings, program effectiveness and efficiency, and public health and safety if implemented.
- On July 23, 2019, OIG released guidance entitled, A Resource Guide for Using Diagnosis Codes in Health Insurance Claims to Help Identify Unreported Abuse or Neglect. This resource guide explains OIG’s approach to using claims data to identify incidents of potential abuse or neglect of vulnerable populations. The guide synthesizes the methodologies that OIG developed in their extensive work on identifying unreported critical incidents, particularly those involving potential abuse or neglect. These methodologies were used in work examining a variety of care settings, including nursing facilities and group homes. The guide includes a flow chart showing key decision points in the process and the detailed lessons that the OIG has learned using this approach. OIG encourages their public and private sector partners to use this guide to develop a process tailored to their specific circumstances and apply it to any vulnerable population they deem appropriate. The guide also provides technical information, such as examples of medical diagnosis codes, to support OIG public and private sector partners with analyzing their own claims data to help combat abuse and neglect.
- On July 25, 2019, Bipartisan Policy Center released a report entitled, Next Steps in Chronic Care. Recognizing the need to continue efforts to improve care for those with chronic conditions, this report makes recommendations in three areas: 1) Providing greater authority to CMS to integrate services for Medicare-Medicaid beneficiaries; 2) Improving on the Bipartisan Budget Act provisions allowing Medicare Advantage plans to offer special supplemental benefits for individuals with chronic illness; and 3) Improving care for those with chronic conditions in Medicare fee-for-service through Accountable Care Organizations, primary care models, and chronic care management.
IV. Other Health Policy News
- On July 25, 2019, HHS, through the Health Resources and Services Administration (HRSA), awarded almost $42 million in funding to 49 Health Center Controlled Networks (HCCNs). These awards will enable the HCCNs to support 1,183 federally funded health centers across all 50 states, the District of Columbia and Puerto Rico to expand the use of health information technology (health IT). More information about this action is available here.