Below is Alston & Bird’s Healthcare 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 February 20, 2020, the Food and Drug Administration issued a final rule to define the term “biological product.” Read more about this regulation and other news below.

I. Regulations, Notices, & Guidance

• On February 19, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics. This guidance expands upon, consolidates, and supplements the recommendations on nonclinical immune system assessments provided across multiple guidance documents, most notably the International Conference on Harmonization (ICH) guidance for industry “S8 Immunotoxicity Studies for Human Pharmaceuticals.” The topics addressed include multiple aspects of immune suppression, modulation, and stimulation, including carcinogenicity assessment, dermal sensitization, adjuvanted vaccine development, and developmental and juvenile animal studies.
• On February 20, 2020, FDA issued a final rule entitled, Definition of the Term Biological Product. FDA is issuing this rule to amend its regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 and the Further Consolidated Appropriations Act, 2020, and to provide its interpretation of the statutory term “protein.” Under this final rule, the term protein means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This final rule is intended to clarify the statutory framework under which such products are regulated.
• On February 20, 2020, FDA issued a proposed rule entitled, Microbiology Devices: Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests. The FDA is proposing to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests, postamendments class III devices with the product code MZF, into class II (special controls), subject to premarket notification. FDA is also proposing new device classification regulations along with special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. FDA is proposing this reclassification on its own initiative. If finalized, this order will reclassify these types of devices from class III (premarket approval) to class II (special controls) and reduce the regulatory burdens associated with these devices, as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a premarket notification (510(k)) and receive clearance before marketing their device.
• On February 20, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Comprehensive Care for Joint Replacement Model Three Year Extension and Changes to Episode Definition and Pricing. This proposed rule would revise certain aspects of the Comprehensive Care for Joint Replacement (CJR) model including the episode of care definition, the target price calculation, the reconciliation process, the beneficiary notice requirements and the appeals process. In addition, for proposed performance years 6 through 8, it would eliminate the 50 percent cap on gainsharing payments, distribution payments, and downstream distribution payments for certain recipients. This proposed rule would also extend the additional flexibilities provided to hospitals related to certain Medicare program rules consistent with the revised episode of care definition. Additionally, the proposed rule would allow time to test the proposed changes by extending the length of the CJR model for an additional 3 years, through December 31, 2023, for certain participant hospitals. Finally, it solicits comment on how CMS might best conceptualize and design a future bundled payment model focused on lower extremity joint replacements procedures performed in the ambulatory surgical center setting.
• On February 21, 2020, FDA issued guidance entitled, Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. FDA has identified certain submission types that warrant an exemption (Type III drug master files (DMFs)) or a long-term waiver (certain positron emission tomography (PET) drug products and certain Type II DMFs supporting PET drugs or noncommercial submissions or applications) from the requirement to submit to the Agency in electronic common technical document (eCTD) format. In addition, this guidance outlines certain circumstances where FDA may determine that a short-term waiver from eCTD submission requirements could be granted. This guidance finalizes the revised draft guidance of the same title issued in July 2019 and replaces the final guidance issued in January 2019 (Revision 6).

Event Notices

• 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 2-4, 2020: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, National Advisory Committee on Rural Health and Human Services (NACRHHS). NACRHHS provides advice and recommendations to the Secretary of the Department of Health and Human Services (HHS) on policy, program development, and other matters of significance concerning both rural health and rural human services.
• 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, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, CBER.
• March 9, 2020: FDA and the Federal Trade Commission (FTC) announced a public workshop entitled, Workshop on a Competitive Marketplace for Biosimilars. The purpose of the public workshop is to discuss FDA and FTC's collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading communications about biosimilars, and deter anticompetitive behaviors in the biologic product marketplace.
• March 10, 2020: FDA announced a public meeting entitled, Patient-Focused Drug Development for Stimulant Use Disorder. The purpose of the meeting is to allow FDA to obtain stakeholder perspectives on the impact of stimulant use disorder and views on treatment approaches for stimulant use disorder.

II. Congressional Hearings

There were no health-related hearings this week.

III. Reports, Studies, & Analyses

• On February 18, 2020, JAMA published a study entitled, Private Equity Acquisitions of Physician Medical Groups Across Specialties, 2013-2016. Examining U.S. physician group practice acquisitions by private equity firms using the Irving Levin Associates Health Care M&A data set, the authors of the study found that acquisition of physician practices by private equity firms accelerated between 2013 and 2016, with unknown implications for care delivery and patient outcomes. In this study, the authors describe the physician group practices acquired during this time span across specialties.
• On February 19, 2020, the Kaiser Family Foundation published its updated Preventative Services Tracker. The Affordable Care Act (ACA) requires new private health insurance plans to cover many recommended preventive services without any patient cost-sharing. For adults, the required services are recommended by the U.S. Preventive Services Task Force, the Advisory Committee on Immunization Practices, and HRSA based on recommendations issued by the Institute of Medicine Committee on Women’s Clinical Preventive Services. As new recommendations are issued or updated, coverage must commence in the next plan year that begins on or after exactly one year from the recommendation’s issue date. This tracker presents up-to-date information on the adult preventive services non-grandfathered private plans must cover, by condition, including a summary of the recommendation, the target population, the effective date of coverage, and related federal coverage clarifications.
• On February 19, 2020, the pharmacy benefit manager (PBM) organization Pharmaceutical Care Management Association (PCMA) published a study entitled, Pharmacy Benefit Managers: Generating Savings for Plan Sponsors and Consumers. The study concluded that PBM tools provide substantial savings to plan sponsors and consumers. Plan sponsors balance controlling costs against minimizing change for their members, all while ensuring access to needed care. Savings can range from 20 percent to 30 percent, from limited use to high/incentivized use of PBM tools consistent with best practices. At current/average use, PBM tools will save $1 trillion compared to low or limited use over the next decade. In addition to these expected savings, an additional $1 trillion could be saved if all plan sponsors adopted high use of PBM tools best practices. Likewise, $1 trillion could be lost if PBM tools are limited by government policies or other factors.

IV. Other Health Policy News

• On February 18, 2020, HHS announced that it is taking further steps to prepare for and address the 2019 Novel Coronavirus (SARS-CoV-2). First, as part of the rapid global response to SARS-CoV-2, the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) will use an existing partnership with Janssen Research & Development, part of Johnson & Johnson, to help develop treatments for coronavirus infections. The Biomedical Advanced Research and Development Authority (BARDA), part of ASPR, will collaborate with Janssen to identify medicines that might be used safely and effectively to reduce the severity of illness and treat coronavirus infections. The company also will identify compounds that have antiviral activity against SARS-CoV-2 as an initial step in developing new treatments. Currently, there are no vaccines or therapeutics approved by FDA to treat or prevent novel coronavirus infections. Read more about this partnership here. HHS has also engaged Sanofi Pasteur, the vaccines global business unit of Sanofi, to develop a vaccine against SARS-CoV-2. BARDA will provide expertise and reallocated funds to support the vaccine’s development. Sanofi will use its egg-free, recombinant DNA platform to produce a recombinant 2019 novel coronavirus vaccine candidate. For more information about the vaccine development, go here.
• On February 21, 2020, HHS announced the publication of its Strategy on Reducing Regulatory and Administrative Burden Relating to the Use of Health IT and EHRs. This report describes examples of electronic health record (EHR) related burden, as well as strategies and recommendations that HHS and other stakeholders can use to help clinicians focus their attention on patients rather than paperwork, when they use health information technology (health IT). The finalized report reflects additional input from the more than 200 comments submitted in response to the draft strategy and recommendations. The report outlines three primary goals and offers recommendations to:
  • Reduce the effort and time required to record information in EHRs for health care providers when they are seeing patients;
  • Reduce the effort and time required to meet regulatory reporting requirements for clinicians, hospitals, and health care organizations; and
  • Improve the functionality and intuitiveness (ease of use) of EHRs.

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