Alston & Bird Health Care Week in Review, January 24, 2020

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.

Week in Review Highlight of the Week:

On January 21, the U.S. Supreme Court rejected petitions to expedite a challenge to a lower court's ruling that the ACA’s individual mandate is unconstitutional. Read more about this decision and other news below.

I. Regulations, Notices, & Guidance

• On January 21, 2020, the Food and Drug Administration (FDA) issued a final rule entitled, Medical Devices; Radiology Devices: Classification of the Radiological Computer Aided Triage and Notification Software. FDA is classifying the radiological computer aided triage and notification software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological computer aided triage and notification software’s classification. FDA is taking this action because they have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On January 21, 2020, FDA issued a final rule entitled, Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer. FDA is classifying the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological CADx software for lesions suspicious for cancer’s classification. FDA is taking this action because they have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On January 21, 2020, FDA issued a final rule entitled, Radiology Devices; Reclassification of Medical Image Analyzers. FDA is issuing a final order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, postamendments class III devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. These devices are intended to direct the clinician’s attention to portions of an image that may reveal abnormalities during interpretation of patient radiology images by the clinician. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device type.
• On January 22, 2020, FDA issued guidance entitled, Clinical Drug Interaction Studies and In Vitro Drug Interaction Studies; Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions. FDA is announcing the availability of two final guidances for industry entitled "Clinical Drug Interaction Studies—Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions" and "In Vitro Drug Interaction Studies—Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions." These final guidances are intended to assist drug developers in the planning and evaluation of drug-drug interaction (DDI) potential during drug development and describe a systematic, risk-based approach to the assessment of DDIs.
• On January 22, 2020, FDA issued guidance entitled, Levonorgestrel; Intrauterine Device. The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for a levonorgestrel intrauterine device.
• On January 22, 2020, FDA issued guidance entitled, Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in - Premarket Notification (510(k)) Submissions. This guidance document provides recommendations to industry, systems and service providers, consultants, FDA staff, and others regarding clinical performance assessment of computer-assisted detection (CADe) devices applied to radiology images and radiology device data. CADe devices are computerized systems that incorporate pattern recognition and data analysis capabilities (i.e., combine values, measurements, or features extracted from the patient radiological data) intended to identify, mark, highlight, or in any other manner direct attention to portions of an image, or aspects of radiology device data, that may reveal abnormalities during interpretation of patient radiology images or patient radiology device data by the intended user (i.e., a physician or other health care professional).
• On January 22, 2020, FDA issued guidance entitled, Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. This guidance describes FDA’s policies regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound human drugs and register with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
• On January 23, 2020, the Department of Health and Human Resources (HHS) issued a final rule entitled, Modification of the Requirements for the Use of Health Insurance Portability and Accountability Act of 1996 National Council for Prescription Drug Programs D.0 Standard. This final rule adopts a modification of the requirements for the use of the Telecommunication Standard Implementation Guide, Version D, Release 0 (Version D.0), August 2007, National Council for Prescription Drug Programs, by requiring covered entities to use the Quantity Prescribed (460-ET) field for retail pharmacy transactions for Schedule II drugs. The modification enables covered entities to distinguish whether a prescription is a “partial fill,” where less than the full amount prescribed is dispensed, or a refill, where the full amount prescribed is dispensed, in the HIPAA retail pharmacy transactions. This modification is important to ensure the availability of a greater quantum of data that may help prevent impermissible refills of Schedule II drugs, which will help to address the public health concerns associated with prescription drug abuse in the United States.
• On January 23, 2020, FDA issued guidance entitled, Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry. This guidance provides stakeholders information regarding FDA’s implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) under Title IV of the FDA Reauthorization Act of 2017. Because BsUFA II created changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.
• On January 24, 2020, FDA issued guidance entitled, Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment. This guidance is intended to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials conducted under an investigational new drug application (IND) or to support marketing approval of drugs and biological products for treating specific hematologic malignancies. An analysis of marketing applications showed inconsistent quality of MRD data. Based on this analysis and discussion at various public workshops on MRD, FDA identified a need to provide guidance on the use of MRD as a biomarker in regulatory submissions.

Event Notices       

• January 27, 2020: HHS announced a public meeting entitled, Advisory Council on Alzheimer’s Research, Care, and Services. During the meeting, an invited panel will present lessons from epidemiology on understanding current rates of dementia, future trends, and potential preventive strategies. The Advisory Council will hear about the Department of Defense’s Peer Reviewed Alzheimer’s Research Program as well as an update on the recommendations from the Alzheimer’s Disease-Related Dementias Research Summit. Federal workgroups will also provide updates on work completed in the last quarter.
• January 28, 2020: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Meeting of the Substance Abuse and Mental Health Services Administration’s National Advisory Council. The meeting will include remarks and dialogue from the Assistant Secretary for Mental Health and Substance Use; updates from the SAMHSA Centers Directors, and a council discussion on clinical trends and emerging national issues with SAMHSA NAC members.
• January 30-31, 2020: 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 access to and success of clinical prevention services among racial and ethnic minority populations. The recommendations will be given to the Deputy Assistant Secretary for Minority Health to inform efforts related to the Department’s community-wide, chronic disease prevention strategies.
• February 13-14, 2020: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee. During the February 2020 meeting, sessions will focus on vaccine innovation and vaccine confidence with updates from subcommittees and members.
• February 24, 2020: FDA announced a public meeting entitled, Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development. The goal of this meeting is to obtain stakeholders' perspectives on challenges and solutions in rare disease product development and identify commonalities that can support product development across a variety of rare diseases.
• February 26, 2020: FDA announced a public meeting entitled, Oncologic Drugs Advisory Committee. During the morning session, the committee will discuss new drug application 212578 for padeliporfin di-potassium powder for solution for injection, submitted by STEBA Biotech, S.A. The proposed indication (use) for this product is for the treatment of patients with localized prostate cancer. During the afternoon session, the committee will discuss supplemental biologics license application 125477/S-034, for CYRAMZA (ramucirumab) injection for intravenous use, submitted by Eli Lilly and Company. The proposed indication (use) for this product is in combination with erlotinib, for first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 (L858R) substitution mutations.
• March 4, 2020: FDA announced a public meeting entitled, Vaccines and Related Biological Products Advisory Committee. The committee will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2020 to 2021 influenza season. Also, on March 4, 2020, under Topic II, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Respiratory and Special Pathogens (LRSP), Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, CBER.

II. Congressional Hearings

There were no health-related hearings this week.

III. Reports, Studies, & Analyses

• On January 21, 2020, the Government Accountability Office (GAO) published a report entitled, Artificial Intelligence in Health Care: Benefits and Challenges of Machine Learning in Drug Development. The report was published in conjunction with the National Academy of Medicine (NAM) and analyzes the use of machine learning in the development of new drug products. In their report, GAO identifies several challenges that hinder the adoption and impact of machine learning in drug development. Gaps in research in biology, chemistry, and machine learning limit the understanding of and impact in this area. A shortage of high-quality data, which are required for machine learning to be effective, is another challenge. Accessing and sharing these data is also difficult, due to costs, legal issues, and a lack of incentives for sharing. Furthermore, a low supply of skilled and interdisciplinary workers creates hiring and retention challenges for drug companies. Lastly, uncertainty about potential regulation of machine learning used in drug development may limit investment in this field. GAO developed six policy options in response to these challenges. Five policy options are centered around research, data access, standardization, human capital, and regulatory certainty. The last is the status quo, whereby policymakers—federal agencies, state and local governments, academic and research institutions, and industry, among others—would not intervene with current efforts.
• On January 23, 2020, Kaiser Family Foundation published an issue brief entitled, Pricing and Payment for Medicaid Prescription Drugs. The cost of prescription drugs is a leading health policy issue in the United States, with 79 percent of the public believing that the cost of prescription drugs is unreasonable and both major parties introducing legislation aimed at lowering drug costs. Though much of the focus of the current debate is on the effect of drug prices on consumer spending within Medicare and commercial insurance, proposed policy changes may have implications for Medicaid as well. This brief explains Medicaid prescription drug prices to help policymakers and others understand Medicaid’s role in drug pricing and any potential consequences of policy changes for the program by examining: (1) what factors determine Medicaid prices for prescription drugs; (2) how prices impact Medicaid spending; and (3) the policy debates and proposals that exist regarding Medicaid pricing.

IV. Other Health Policy News

• On January 21, 2020, the Centers for Medicare & Medicaid Services (CMS) announced that Medicare will begin to cover acupuncture services for beneficiaries with chronic back pain. People enrolled in Medicare will be able to receive up to 12 acupuncture treatments during a 90-day period if they have non-specific lower back pain that lasts 12 weeks or more, but not if it is not associated with surgery or pregnancy. They will be eligible for eight more sessions if their symptoms improve, but Medicare will not cover more than 20 sessions each year. Congress and the administration have sought to expand coverage for non-opioid pain management treatments to reduce the health care system's reliance on opioids to treat pain and cut down on substance use disorder.
• On January 21, 2020, the U.S. Supreme Court rejected an effort by Democrats to expedite a challenge to a lower court's ruling striking down a key tenet of the Affordable Care Act (ACA), narrowing the possibility that the court takes up the case this year. The House of Representatives and a group of blue states had asked the court to fast-track their appeal after the 5th Circuit Court of Appeals ruled that the ACA’s individual mandate is unconstitutional. The Supreme Court’s statement means the petitions will now proceed through the court’s normal process: both sides will submit more briefs in the coming weeks or months, followed by a decision from the court on whether to review the 5th Circuit’s decision.

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