Alston & Bird Health Care Week in Review, April 3, 2020

Week in Review Highlight of the Week:

On March 31, 2020, the Centers for Medicare & Medicaid Services released an interim final rule to give the U.S. health care system the flexibility to address COVID-19. Read more about the rule and other news below.

I. Regulations, Notices, & Guidance

• On March 29, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. FDA is issuing this guidance to provide a policy to help expand the availability and capability of sterilizers, disinfectant devices, and air purifiers during this public health emergency. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act).
• On March 30, 2020, FDA issued guidance entitled, Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency. FDA is issuing this guidance to provide a policy to help expand the availability of surgical apparel for health care professionals, including gowns (togas), hoods, and surgeon’s and patient examination gloves during this pandemic. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the HHS including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the PHS Act.
• On March 31, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule entitled, Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency. This interim final rule with comment period (IFC) gives individuals and entities that provide services to Medicare beneficiaries needed flexibilities to respond effectively to the serious public health threats posed by the spread of COVID-19. CMS is changing Medicare payment rules during the Public Health Emergency (PHE) for the COVID-19 pandemic so that physicians and other practitioners, home health and hospice providers, inpatient rehabilitation facilities, rural health clinics, and federally qualified health centers are allowed broad flexibilities to furnish services using remote communications technology to avoid exposure risks to health care providers, patients, and the community. CMS is also altering the applicable payment policies to provide specimen collection fees for independent laboratories collecting specimens from beneficiaries who are homebound or inpatients (not in a hospital) for COVID-19 testing. CMS is also expanding, on an interim basis, the list of destinations for which Medicare covers ambulance transports under Medicare Part B. In addition, CMS is making programmatic changes to the Medicare Diabetes Prevention Program and the Comprehensive Care for Joint Replacement Model in light of the PHE, and program-specific requirements for the Quality Payment Program to avoid inadvertently creating incentives to place cost considerations above patient safety. This IFC will modify the calculation of the 2021 and 2022 Part C and D Star Ratings to address the expected disruption to data collection and measure scores posed by the COVID-19 pandemic and also to avoid inadvertently creating incentives to place cost considerations above patient safety. This rule also amends the Medicaid home health regulations to allow other licensed practitioners to order home health services, for the period of this PHE for the COVID-19 pandemic in accordance with state scope of practice laws. CMS is also modifying its under arrangements policy during the PHE for the COVID-19 pandemic so that hospitals are allowed broader flexibilities to furnish inpatient services, including routine services outside the hospital.
• On April 1, 2020, FDA issued a proposed rule entitled, Microbiology Devices: Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices. The FDA is proposing to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, postamendments class III devices (product codes MZP and OBF), into class II (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name “nucleic acid-based Hepatitis C virus (HCV) ribonucleic acid tests” along with the 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 (general controls and premarket approval) to class II (general controls and 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 obtain clearance before marketing their device.
• On April 1, 2020, FDA issued a proposed rule entitled, Microbiology Devices: Reclassification of Certain Hepatitis C Virus Antibody Assays Devices. The FDA is proposing to reclassify certain HCV antibody assay devices intended for the qualitative detection of HCV, postamendments class III devices (product code MZO) into class II (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "hepatitis C virus (HCV) antibody tests" along with the 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 (general controls and premarket approval) to class II (general controls and special controls) and reduce the regulatory burdens associated with these devices, as these types of devices will no longer be required to submit a PMA, but can instead submit a premarket notification under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and obtain clearance before marketing their device.
• On April 2, 2020, FDA issued guidance entitled, Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised). FDA is issuing this guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals during this pandemic. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the HHS, including any renewals made by the Secretary in accordance with section 319(a)(2) of the PHS Act.
• On April 2, 2020, FDA issued guidance entitled, Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria. This revised guidance document provides blood establishments that collect blood and blood components with FDA’s recommendations to reduce the risk of transfusion-transmitted malaria (TTM). The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma. Blood establishments are not required to assess Source Plasma donors for malaria risk (see 21 CFR 630.15(b)(8)).
• On April 2, 2020, FDA issued guidance entitled, Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. This revised guidance document provides blood establishments that collect blood or blood components including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. FDA is also recommending making corresponding revisions to donor educational materials, donor history questionnaires and accompanying materials, along with revisions to donor requalification and product management procedures.  The recommendations contained in this guidance apply to the collection of blood and blood components, including Source Plasma.
• On April 2, 2020, FDA issued guidance entitled, Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components. FDA is issuing this guidance document to provide blood establishments that collect blood and blood components with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components. The recommendations in this guidance apply to the collection of whole blood and blood components intended for transfusion or for use in further manufacturing, including source plasma. FDA is revising or removing its prior recommendations to screen blood donors for: 1) geographic risk of possible exposure to bovine spongiform encephalopathy, including time spent on U.S. military bases in Europe; 2) receipt of a blood transfusion in certain vCJD risk countries; 3) risk factors for iatrogenic CJD (i.e., a history of taking human cadaveric pituitary-derived growth hormone (hGH)); 4) having blood relatives with CJD; and 5) a history of injecting bovine insulin.
• On April 2, 2020, FDA issued guidance entitled, Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency. FDA is issuing this guidance to provide a notice of exceptions and alternatives to certain requirements in Title 21 of the Code of Federal Regulations (CFR) regarding blood and blood components. This notice of exception or alternatives to certain requirements is being issued under 21 CFR 640.120(b) to respond to a national public health need and address the urgent and immediate need for blood and blood components. FDA expects that the alternative procedures will improve availability of blood and blood components while helping to ensure adequate protections for donor health and maintaining a safe blood supply for patients.
• On April 2, 2020, HHS issued a final rule entitled, Enforcement Discretion under HIPAA to Allow Uses and Disclosures of Protected Health Information by Business Associates for Public Health and Health Oversight Activities in Response to COVID-19. This notification is to inform the public that HHS is exercising its discretion in how it applies the Privacy Rule under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Current regulations allow a HIPAA business associate to use and disclose protected health information for public health and health oversight purposes only if expressly permitted by its business associate agreement with a HIPAA covered entity. As a matter of enforcement discretion, effective immediately, the HHS Office for Civil Rights (OCR) will exercise its enforcement discretion and will not impose potential penalties for violations of certain provisions of the HIPAA Privacy Rule against covered health care providers or their business associates for uses and disclosures of protected health information by business associates for public health and health oversight activities during the COVID-19 nationwide public health emergency.

Event Notices

• April 15, 2020: The National Institutes of Health (NIH) announced a Committee meeting of the National Institute of Allergy and Infectious Diseases Special Emphasis Panel NIAID Resource-Related Research Projects.
• April 16, 2020: The FDA announced a public meeting entitled, Scientific and Ethical Considerations for the Inclusions of Pregnant Women in Clinical Trials. The meeting is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development.
• April 20, 2020: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Meeting of the National Advisory Council on Nurse Education and Practice. During the meeting, the writing sub-committee of NACNEP will review recent literature and hear from an expert speaker on the topic of its 17th Report to Congress, Preparing Nurse Faculty, and Addressing the Shortage of Nurse Faculty and Clinical Preceptors.

II. Congressional Hearings

There were no health-related hearings this week.

III. Reports, Studies, & Analyses

• On April 1, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, Examining Medicare Part D Policies for Extended Supplies of Medication. This analysis examines the share of Medicare Part D enrollees who have access to extended supplies of generic, brand-name, and specialty-tier drugs covered by their plan in 2020, under policies that applied prior to the change in law, and that will apply after the COVID-19 emergency declaration ends, when Part D plans will no longer be required by law to issue extended supplies for all Part D drugs they cover.
• On April 3, 2020, KFF published an issue brief entitled, Long-Term Trends in Employer-Based Coverage. As the economic consequences of COVID-19 continue to play out, many households may lose access to employer sponsored coverage. Recent data from the Bureau of Labor Statistics indicates a record number of jobless claims, suggesting a marked increase in unemployment over the next couple of months and potentially longer. This updated brief examines long-term trends in employer-based coverage and offer rates over the last two decades. It also looks at the types of households which may be vulnerable as employer coverage continues to change and the economy responds to the pandemic.

IV. Other Health Policy News

• On April 2, 2020, the U.S. Department of Justice (DOJ) and HHS announced the distribution of hoarded personal protective equipment (PPE), including approximately 192,000 N95 respirator masks, to those on the frontline of the COVID-19 response in New York and New Jersey. The Federal Bureau of Investigation discovered the supplies during an enforcement operation by the DOJ's COVID-19 Hoarding and Price Gouging Task Force on March 30 and alerted HHS, which used its authority under the Defense Production Act to order that the supplies be immediately furnished to the United States. In addition to the N95 respirator masks, the supplies found included 598,000 medical grade gloves and 130,000 surgical masks, procedure masks, N100 masks, surgical gowns, disinfectant towels, particulate filters, bottles of hand sanitizer, and bottles of spray disinfectant. More information about this action can be found here.
• On April 2, 2020, CMS, in consultation with the Centers for Disease Control and Prevention (CDC), issued critical recommendations to state and local governments, as well as nursing homes, to help mitigate the spread of COVID-19 in nursing homes. The recommendations build on and strengthen recent guidance from CMS and CDC related to effective implementation of longstanding infection control procedures. More information on CMS’ recommendations can be found here.

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