Alston & Bird Health Care Week in Review, August 16, 2019

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 August 12, 2019, the Department of Homeland Security (DHS) issued a final rule entitled, Inadmissibility on Public Charge Grounds. This final rule amends DHS regulations by prescribing how DHS will determine whether an alien applying for admission or adjustment of status is inadmissible to the United States under section 212(a)(4) of the Immigration and Nationality Act (INA or the Act), because he or she is likely at any time to become a public charge. The final rule includes definitions of certain terms critical to the public charge determination, such as “public charge” and “public benefit,” which are not defined in the statute, and explains the factors DHS will consider in the totality of the circumstances when making a public charge inadmissibility determination. The final rule also addresses United States Citizenship and Immigration Services’ (USCIS) authority to issue public charge bonds under section 213 of the Act in the context of applications for adjustment of status. Finally, this rule includes a requirement that aliens seeking an extension of stay or change of status demonstrate that they have not, since obtaining the nonimmigrant status they seek to extend or change, received public benefits over the designated threshold, as defined in this rule.
• On August 13, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Child-Resistant Packaging Statements in Drug Product Labeling. This guidance is intended to assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging (CRP) statements in prescription and over-the-counter human drug product labeling. The guidance discusses what information should be included to support CRP statements and to help ensure that such labeling is clear, useful, informative, and, to the extent possible, consistent in content and format.
• On August 13, 2019, FDA issued draft guidance entitled, Gastroparesis: Clinical Evaluation of Drugs for Treatment. This draft guidance is intended to provide the FDA’s current thinking regarding clinical trial design and clinical endpoint assessments to support development of drugs for the treatment of diabetic and idiopathic gastroparesis. This draft guidance replaces the draft guidance for industry of the same name issued July 23, 2015.
• On August 14, 2019, FDA issued guidance entitled, Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment; Guidance for Industry. The purpose of this guidance is to provide recommendations to industry for designing nonclinical bone quality studies to support the approval of drugs and biologics (e.g., recombinant proteins and monoclonal antibodies regulated by the Center for Drug Evaluation and Research) intended for the treatment of osteoporosis
• On August 15, 2019, the Drug Enforcement Administration (DEA) issued a final rule entitled, Listing of Noroxymorphone in the Code of Federal Regulations and Assignment of a Controlled Substances Code Number. Noroxymorphone is a derivative of opium and opiates and, as such, is a schedule II controlled substance. The DEA has established the use of the Drug Enforcement Administration Code Number 9668 for tracking noroxymorphone and for establishing aggregate production quotas. This rule amends the Code of Federal Regulations (CFR) to reflect the current practice of using the Code Number 9668 for noroxymorphone. This rulemaking will list the schedule II controlled substance noroxymorphone as a basic class with the Code Number 9668. This rule does not affect the control of noroxymorphone as a schedule II controlled substance.

Event Notices         

• August 21, 2019: The Department of Health and Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Center for Substance Abuse Prevention. The meeting will include discussion of the substance use prevention workforce, as well as marijuana and HIV. The meeting will also include updates on Center for Substance Abuse Prevention (CSAP) program developments.
• August 22-23, 2019: HHS announced a public meeting entitled, Meeting of the Advisory Committee on Minority Health. The topics to be discussed during this meeting will include strategies to improve the health of racial and ethnic minority populations through the development of health policies and programs that will help eliminate health disparities with an emphasis on infectious disease, particularly HIV and Hepatitis B. The recommendations will be given to the Deputy Assistant Secretary for Minority Health.
• September 9-11, 2019: HRSA announced a public meeting entitled, National Advisory Committee on Rural Health and Human Services. The National Advisory Committee on Rural Health and Human Services (NACRHHS) provides advice and recommendations to the Secretary of HHS on policy, program development, and other matters of significance concerning both rural health and rural human services. During the September 9, 2019, through September 11, 2019, meeting, NACRHHS will examine the current delivery of health care and human services in rural areas. Agenda items are subject to change as priorities dictate. Refer to the NACRHHS website for any updated information concerning the meeting.
• September 11-12, 2019: FDA announced a public workshop entitled, Food and Drug Administration Science Forum 2019. The purpose of the public workshop is to share with the public the unique scientific research and collaborative efforts of FDA’s 11,000 scientists and researchers, who use novel science and technologies to inform FDA’s regulatory decision-making--and drive innovation.
• October 16-17, 2019: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Community Preventive Services Task Force (CPSTF). The CPSTF is an independent, nonfederal panel whose members are appointed by the CDC Director. CPSTF members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health. Matters proposed for discussion during the upcoming meeting include: Cancer Prevention and Control; Obesity Prevention and Control; Pregnancy Health; and Tobacco Cessation.
• November 7, 2019: FDA announced a public meeting entitled, Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs. The purpose of the public meeting is to solicit specific, actionable policy suggestions that could be implemented in the near-term by the review staff of the Center for Drug Evaluation and Research's (CDER's) Office of New Drugs to promote effective drug development programs without compromising FDA regulatory standards for the assessment of safety and effectiveness.

II. Congressional Hearings

• There were no health-related hearings this week.

III. Reports, Studies, & Analyses

• On August 13, 2019, the Government Accountability Office (GAO) released a report entitled, Medicare Part D: Use of Pharmacy Benefit Managers and Efforts to Manage Drug Expenditures and Utilization. GAO was asked to examine the role of pharmacy Benefit Managers (PBMs) in the Part D program. This report examines, among other objectives: 1) The extent to which Part D plan sponsors use PBMs, 2) Trends in rebates and other price concessions obtained by both PBMs and plan sponsors for Part D drugs, and 3) How PBMs earn revenue for services provided to Part D plans. To conduct this study, GAO analyzed Centers for Medicare & Medicaid Services (CMS) data on Part D plan sponsors’ use of PBMs in 2016 as well as CMS drug expenditure, pricing, and rebate and other price concession data for all Part D drugs from 2014 through 2016.
• On August 15, 2019, the Kaiser Family Foundation released an issue brief entitled, The Effects of Medicaid Expansion under the ACA: Updated Findings from a Literature Review. This issue brief summarizes findings from 324 studies of the impact of state Medicaid expansions under the ACA published beginning in January 2014 (when the coverage provisions of the ACA went into effect) and updates earlier versions of this brief with studies through June 2019. More recent studies continue to support earlier findings but provide additional findings in key areas, including expansion’s effects on health outcomes, access to services and medications for behavioral health – including opioid use disorder — and other needs, providers’ financial stability, and employment and the labor market.
• On August 15, 2019, RAND Corporation released a report entitled, The Use of Technology to Augment Clinical Care in Depression and Anxiety Disorders: An Evidence Map. The use of telehealth and online interventions might increase the reach of clinical services for disorders like anxiety and depression, as well as support more comprehensive treatment. This evidence map provides an overview of the existing research on technological approaches in depression and anxiety care. Comprehensive figures and tables document published and upcoming research to evaluate the role of technology to support clinical care. An online, interactive visualization provides direct access to the included studies. The evidence map presents the volume, nature, and characteristics of research in this field and, according to RAND “should be of interest to health policymakers and practitioners who oversee or implement treatment for those conditions.”

IV. Other Health Policy News

• On August 13, 2019, the U.S. District Court of Appeals for the D.C. Circuit reversed a lower court’s ruling and sided with CMS in a move that prevents hospitals from receiving Medicaid DSH payments to cover costs for which they have already been compensated by private insurers or Medicare. More information about the ruling is available here.
• On August 15, 2019, CMS announced that it will, for the first time, require the display of the five-star Quality Rating System (or star ratings) available nationwide for health plans offered on the Health Insurance Exchanges beginning with the 2020 Open Enrollment Period. According to CMS, this action is intended to allow consumers to compare health coverage choices using a five-star quality rating of each plan on Exchange websites, including HealthCare.gov, similar to other CMS star rating programs, such as the Nursing Home Compare website and Medicare Advantage. More information about this action is available here.