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:
This week, CMS and HHS began distributing funds from the CARES Act to support hospitals and health care workers. Read more about these actions and other news below.
I. Regulations, Notices, & Guidance
- On April 4, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. FDA is issuing this guidance to provide a policy to help expand the availability of clinical electronic thermometers to address 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 (PHS) Act.
- On April 5, 2020, FDA issued guidance entitled, Enforcement Policy for Infusion Pumps and Accessories 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 remote capabilities of infusion pumps and their accessories for health care professionals during the COVID-19 pandemic. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the PHS Act.
- On April 6, 2020, the Drug Enforcement Administration (DEA) issued a proposed rule entitled, Schedules of Controlled Substances: Placement of 4,4'-DMAR in Schedule I. The DEA proposes placing the substance 4,4’-DMAR (Chemical name: 4,4’-dimethylaminorex), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act (CSA). This action is being taken to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle 4,4’-DMAR.
- On April 6, 2020, the DEA issued an interim final rule entitled, Schedules of Controlled Substances: Placement of Lemborexant in Schedule IV. On December 20, 2019, the FDA approved a new drug application for Dayvigo (lemborexant) tablets for oral use. Lemborexant is chemically known as (1R,2S)-2-[(2,4-dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)-N-(5-fluoropyridin-2-yl)cyclopropane-1-carboxamide. HHS provided the DEA with a scheduling recommendation to place lemborexant in schedule IV of the CSA. In accordance with the CSA, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing lemborexant, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the CSA.
- On April 6, 2020, FDA issued guidance entitled, Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the COVID-19 Public Health Emergency. FDA is issuing this guidance to provide a policy to help expand the capability of remote ophthalmic assessment and monitoring devices to facilitate patient care while reducing patient and healthcare provider contact and exposure to COVID-19 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 April 6, 2020, FDA issued guidance entitled, Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the COVID-19 Public Health Emergency. FDA is issuing this guidance to provide a policy to help expand the availability of devices used in extracorporeal membrane oxygenation (ECMO) therapy to address 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 HHS, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the PHS Act.
- On April 8, 2020, the Federal Communications Commission (FCC) issued a final rule entitled, Promoting Telehealth for Low-Income Consumers; COVID-19 Telehealth Program. This final rule establishes two programs: the COVID-19 Telehealth Program designed to distribute a $200 million appropriation from Congress under the Coronavirus Aid, Relief, and Economic Security (CARES) Act, to help health care providers provide connected care services to patients at their homes or mobile locations in response to the novel COVID-19 pandemic, and the Connected Care Pilot Program (Pilot Program) designed to make available up to $100 million over three years to examine how the Universal Service Fund can help support the trend towards connected care services to consumers, particularly for low-income Americans and veterans.
- On April 8, 2020, FDA issued guidance entitled, Investigational COVID-19 Convalescent Plasma. FDA is issuing this guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. The guidance also provides recommendations to blood establishments on the collection of COVID-19 convalescent plasma.
- On April 9, 2020, HHS issued an interim final rule entitled, Approval Tests and Standards for Air-Purifying Particulate Respirators. HHS is publishing this rule to update the regulatory requirements used by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) to test and approve air-purifying particulate respirators for use in the ongoing public health emergency. With this rulemaking, parallel performance standards are added to existing regulatory requirements for PAPRs to allow for the approval of respirators in a new class, PAPR100, that may be better suited to the needs of workers in the healthcare and public safety sectors currently experiencing a shortage of air-purifying particulate respirators due to COVID-19. This rulemaking also consolidates the technical standards for all types of air-purifying particulate respirators into one subpart, and standards pertaining to obsolete respirators designed for dust, fume, and mist; pesticide; and paint spray are removed from the regulation entirely. This rulemaking will have no substantive impact on the continued certification testing and approval by the NIOSH National Personal Protective Technology Laboratory of existing PAPR class HE (high-efficiency series) respirators or non-powered air-purifying particulate respirators, including N95 filtering facepiece respirators, currently in demand by healthcare workers and emergency responders. NIOSH expects that the addition of PAPR100 devices to the marketplace will help to relieve the current high demand for possibly hundreds of thousands of additional particulate filtering facepiece respirators needed specifically for healthcare and emergency medical response settings.
- On April 9, 2020, FDA issued guidance entitled, Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry. As demand for oxygen and nitrogen intended for medical use increases due to the COVID-19 pandemic, FDA has become aware of concerns regarding a low supply of portable cryogenic medical gas containers and has received inquiries regarding the use of gas containers that do not meet certain regulatory requirements for portable cryogenic medical gas containers (e.g., industrial gas containers). FDA is issuing this guidance to communicate its policy for the temporary use of certain gas containers for oxygen and nitrogen intended for medical use for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020.
- On April 10, 2020, FDA issued guidance entitled, Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency. Due to the COVID-19 pandemic, FDA has received a number of queries from compounders related to the impact of supply interruptions of face masks, gowns, gloves, and other garb (PPE). FDA is issuing this guidance to communicate its temporary policy related to PPE use during human drug compounding, at State-licensed pharmacies, or Federal facilities that are not registered with FDA as outsourcing facilities. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by HHS, including any renewals made by the HHS Secretary in accordance with section 319(A)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)).
- On April 10, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, FY 2021 Inpatient Psychiatric Facilities Prospective Payment System. This proposed rule would update the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an Inpatient Prospective Payment System hospital or critical access hospital. In addition, this proposed rule would adopt the most recent Office of Management and Budget (OMB) statistical area delineations, and apply a 2-year transition for all providers negatively impacted by wage index changes. These changes would be effective for IPF discharges beginning during the FY from October 1, 2020 through September 30, 2021 (FY 2021).
- On April 10, 2020, CMS issued a proposed rule entitled, Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Value-Based Purchasing Program for Federal Fiscal Year 2021. This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for FY 2021. The proposed rule includes proposals to make changes to the case-mix classification code mappings used under the SNF PPS and to make two minor revisions in the regulation text. This proposed rule also includes a proposal to adopt the recent revisions in OMB statistical area delineations. The proposed rule also includes proposals for the Skilled Nursing Facility Value-Based Purchasing (VBP) Program that affects Medicare payment to SNFs.
- On April 10, 2020, CMS issued a proposed rule entitled, FY 2021 Hospice Wage Index and Payment Rate Update. This proposed rule would update the hospice wage index, payment rates, and cap amount for FY 2021. This rule also proposes changes to the hospice wage index by adopting the most recent OMB statistical area delineations, with a 5 percent cap on wage index decreases. Finally, this proposed rule summarizes the changes to the hospice election statement finalized in the FY 2020 Hospice Wage Index and Rate Update final rule and effective for October 1, 2020; and provides hospices with a model election statement and sample addendum.
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.
- May 20, 2020: The NIH announced a public meeting entitled, Meeting of the National Institute of Biomedical Imaging and Bioengineering. The purpose of the meeting is to go over the Report from the Institute Director and other Institute Staff.
- June 8, 2020: The NIH announced a public meeting entitled, Meeting of the Muscular Dystrophy Coordinating Committee. The purpose of this meeting is to bring together committee members, representing government agencies, patient advocacy groups, other voluntary health organizations, and patients and their families to update one another on progress relevant to the Action Plan for the Muscular Dystrophies and to coordinate activities and discuss gaps and opportunities leading to better understanding of the muscular dystrophies, advances in treatments, and improvements in patients' and their families' lives.
II. Congressional Hearings
There were no health-related hearings this week.
III. Reports, Studies, & Analyses
- On April 6, 2020, the Government Accountability Office (GAO) published a report entitled, FDA Drug Approval: Application Review Times Largely Reflect Agency Goals. Before a drug can be marketed in the United States, the FDA must determine it is safe and effective. The company or entity seeking to market the drug must submit evidence for review. FDA’s goal is to complete 90 percent of these reviews within deadlines that vary depending on the drug. Some drugs—ones that may provide significant improvement over what’s available—receive priority designations for expedited reviews. GAO reviewed 637 new drug applications submitted from FY 2014-2018 and found the FDA met its goals. Differences in review times among FDA’s 17 divisions were largely driven by the characteristics of the applications being reviewed.
- On April 7, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, Estimated Cost of Treating the Uninsured Hospitalized with COVID-19. To date, few specifics on the new policy for covering COVID-19 treatment costs of uninsured patients have been released, but administration officials have said that hospitals would get reimbursed at Medicare rates. The administration has not provided any cost estimates for this new policy, other than to say that the funding will come from the $100 billion in the CARES Act. How much of that funding will be used to pay for care for the uninsured is an important part of thinking through the implications of this policy. In this brief, the authors estimate a range of costs for reimbursing hospitals for treatment of COVID-19 for the uninsured and discuss some outstanding questions about the Trump administration’s new policy.
- On April 7, 2020, KFF published an issue brief entitled, Communities of Color at Higher Risk for Health and Economic Challenges due to COVID-19. The COVID-19 outbreak presents potential health and financial challenges for families, which may disproportionately affect communities of color and compound underlying health and economic disparities. This brief analyzes data on underlying health conditions, health coverage and health care access, and social and economic factors by race and ethnicity to provide insight into how the health and financial impacts of COVID-19 may vary across racial/ethnic groups.
IV. Other Health Policy News
- On April 6, 2020, CMS published the Calendar Year (CY) 2021 Rate Announcement, finalizing Medicare Advantage (MA) and Part D payment methodologies for CY 2021. This Rate Announcement addresses comments received on Parts I and II of the CY 2021 Advance Notice, published on January 6 and February 5, 2020, respectively. The final policies in the Rate Announcement will continue to modernize and maximize competition within the MA and Part D programs. More information about the updated methodologies can be found here.
- On April 8, 2020, HHS, through the HRSA, awarded more than $1.3 billion to 1,387 health centers as part of a historic U.S. response to the COVID-19 pandemic. HRSA-funded health centers may use the awards to help communities across the country detect coronavirus; prevent, diagnose, and treat COVID-19; and maintain or increase health capacity and staffing levels to address this public health emergency. This funding comes from the CARES Act, which was signed into law on March 27, 2020. More information on this funding and a list of award recipients can be found here.
- On April 8, 2020, CMS issued a series of updated guidance documents focused on infection control to prevent the spread of COVID-19 in a variety of inpatient and outpatient care settings. The guidance, based on CDC guidelines, will help ensure infection control in the context of patient triage, screening and treatment, the use of alternate testing and treatment sites and telehealth, drive-through screenings, limiting visitations, cleaning and disinfection guidelines, staffing, and more. The guidance is designed to empower local hospitals and healthcare systems, helping them to rapidly expand their capacity to isolate and treat patients infected with COVID-19 from those who are not. Critically, the guidance includes new instructions for dialysis facilities as they work to protect patients with End-Stage Renal Disease (ESRD), who, because of their immunocompromised state and frequent trips to health care settings, are some of the most vulnerable Americans to complications arising from COVID-19. More information about these updated guidelines can be found here.
- As of April 9, 2020, CMS has delivered more than $51 billion in accelerated/advance payments to healthcare providers on the front lines of battling COVID-19 to ensure they have the resources they need to combat this pandemic. This is an increase from the $34 billion that CMS announced in an earlier press release. Processing time for a request of an accelerated or advance payment is now four to six days, down from the previous timeframe of three to four weeks. In a little over a week, CMS has already approved over 21,000 of the 32,000 requests it received from health care providers and suppliers seeking accelerated and advance payments.
- On April 9, 2020, CMS temporarily suspended a number of rules so that hospitals, clinics, and other healthcare facilities can boost their frontline medical staffs as they fight to save lives during the COVID-19 pandemic. These changes affect doctors, nurses, and other clinicians nationwide, and focus on reducing supervision and certification requirements so that practitioners can be hired quickly and perform work to the fullest extent of their licenses. The new waivers sharply expand the workforce flexibilities CMS announced on March 30. More information about the additional waivers can be found here.
- On April 10, 2020, HHS announced that it is beginning the delivery of the initial $30 billion in relief funding to providers in support of the national response to COVID-19 as part of the distribution of the $100 billion provider relief fund provided for in the CARES Act. The $100 billion of funding will be used to support healthcare-related expenses or lost revenue attributable to coronavirus and to ensure uninsured Americans can get the testing and treatment they need without receiving a surprise bill from a provider. The initial $30 billion in immediate relief funds will begin being delivered to providers today. The terms and conditions for accepting the relief funds can be found here.
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