Alston & Bird Health Care Week in Review, April 17, 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 April 16, President Trump and the White House COVID-19 Taskforce issued a three-stage plan for reopening America’s economy. Read more about the guidelines and other news below.

I. Regulations, Notices, & Guidance

• On April 13, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products. This guidance describes considerations for the development and labeling of in vitro companion diagnostic devices (referred to as companion diagnostics in this document) to support the indicated uses of multiple drug or biologic oncology products (referred to as therapeutic products or oncology therapeutic products in this document), when appropriate. The guidance includes factors for considering when broader labeling (i.e., labeling that is expanded) of a companion diagnostic would be appropriate. Oncology companion diagnostics with broader indications will optimally facilitate clinical use.
• On April 14, 2020, FDA issued guidance entitled, Product-Specific Guidances for Chloroquine Phosphate and Hydroxychloroquine Sulfate. In anticipation of increased demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA is taking steps to ensure that adequate supply of these drug products is available by publishing product-specific guidances (PSGs) to support generic drug development for these drugs. The PSG for chloroquine phosphate clarifies that the product is AA rated in the Approved Drug Products with Therapeutic Equivalence Evaluations publication (Orange Book), meaning that there are no known or suspected bioequivalence problems, and no in vivo studies are necessary. The PSG for hydroxychloroquine sulfate adds advice about a Biopharmaceutics Classification System-based biowaiver option. Given this public health emergency, the PSG for chloroquine phosphate is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate. This guidance document is being implemented immediately, but it remains subject to comment in accordance with the FDA’s good guidance practices.
• On April 14, 2020, FDA issued guidance entitled, Enforcement Policy for Digital Health Devices For Treating Psychiatric Disorders 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 digital health therapeutic devices for psychiatric disorders to facilitate consumer and patient use while reducing user and healthcare provider contact and potential exposure to COVID-19 during this pandemic. Psychiatric symptoms and psychiatric disorders are presented in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition and the International Classification of Diseases, 10th Revision. Common symptoms and disorders include depression, alcohol use disorder, anxiety, insomnia, suicidality, autism, attention deficit hyperactivity disorder, obsessive compulsive disorder, and post-traumatic stress disorder. 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 Services (PHS) Act.
• On April 14, 2020, the Drug Enforcement Administration (DEA) issued a final rule entitled, Designation of Benzylfentanyl and 4-Anilinopiperidine, Precursor Chemicals Used in the Illicit Manufacture of Fentanyl, as List I Chemicals. The DEA is finalizing the designation of N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (also known as benzylfentanyl), including its salts, and N-phenylpiperidin-4-amine (also known as 4-anilinopiperidine; N-phenyl-4- piperidinamine; 4-AP) (hereinafter referred to as 4-anilinopiperidine), including its amides, its carbamates, and its salts, as list I chemicals under the Controlled Substances Act (CSA). DEA proposed control of benzylfentanyl and 4-anilinopiperidine due to their use in clandestine laboratories to illicitly manufacture the schedule II controlled substance fentanyl. This rulemaking finalizes the control of benzylfentanyl and 4-anilinopiperidine as list I chemicals.
• On April 16, 2020, FDA issued guidance entitled, Enforcement Policy for Telethermographic Systems 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 telethermographic systems used for body temperature measurements for triage use for the duration of the public health emergency declared by the HHS on January 31, 2020. 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 PHS Act (42 U.S.C. 247d(a)(2)).
• On April 16, 2020, FDA issued guidance entitled, Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency. FDA is issuing this guidance to communicate its temporary policy for the compounding of certain human drug products for hospitalized patients by outsourcing facilities that have registered with FDA under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b).
• On April 16, 2020, DEA issued a final rule entitled, Control of the Immediate Precursor Norfentanyl Used in the Illicit Manufacture of Fentanyl as a Schedule II Controlled Substance. The DEA is designating the precursor chemical, N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl) as an immediate precursor for the schedule II controlled substance fentanyl. Furthermore, DEA is finalizing the control of norfentanyl as a schedule II substance under the CSA.
• On April 16, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2021. This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2021. As required by statute, this proposed rule includes the classification and weighting factors for the IRF prospective payment system’s case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2021. CMS is proposing to adopt the most recent Office of Management and Budget statistical area delineations and apply a 5 percent cap on any wage index decreases compared to FY 2020 in a budget neutral manner. CMS is also proposing to amend the IRF coverage requirements to remove the post-admission physician evaluation requirement and codify existing documentation instructions and guidance. Additionally, CMS is proposing to amend the IRF coverage requirements to allow non-physician practitioners to perform certain requirements that are currently required to be performed by a rehabilitation physician.
• On April 17, the Public Health Service (PHS) issued a final rule entitled, Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service. HHS is issuing this final rule to amend regulations for the Senior Biomedical Research Service, a component of the Public Health Service. These amendments are necessary to ensure consistency with amendments made to the 21st Century Cures Act to improve scientific expertise and outreach within the Service.

Event Notices

• 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 12, 2020: The National Institutes of Health (NIH) announced a public meeting entitled, Meeting of the National Cancer Institute. The purpose of this meeting is to go over Director’s Report; RFA, RFP, and PAR Concept Reviews; and Scientific Presentations.
• May 20, 2020: 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 1-2, 2020: CMS announced a public meeting entitled, New Public Requests for Revisions to the Healthcare Common Procedure Coding System (HCPCS) Coding for Durable Medical Equipment and Accessories, Orthotics and Prosthetics, Supplies and Other Non-Drug and Non-Biological Items. The purpose of this meeting is to discuss CMS’s preliminary coding recommendations for new public requests for revisions to the HCPCS Level II code set for Durable Medical Equipment (DME) and Accessories, Orthotics and Prosthetics (O&P), Supplies, and other non-drug and non-biological items.
• June 8, 2020: 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 15, 2020, the Kaiser Family Foundation (KFF) published an issue brief entitled, How Health Costs Might Change with COVID-19. As the coronavirus spreads rapidly across the United States, private health insurers and government health programs could potentially face higher health care costs. However, the extent to which costs grow, and how the burden is distributed across payers, programs, individuals, and geography are still very much unknown. This brief lays out a framework for understanding changes in health costs arising from the coronavirus pandemic, including the factors driving health costs upward and downward. The authors also highlight some special considerations for private insurers, Medicare, and Medicaid programs.
• On April 15, 2020, KFF published an issue brief entitled, How Much More Than Medicare Do Private Insurers Pay? A Review of the Literature. Prior to the COVID-19 outbreak, national and state-level policymakers were already debating several proposals that would build on Medicare’s payment structure—including Medicare-for-All and various public option proposals—to establish standardized rates for hospitals, physicians, and other health care providers. While supporters point to potential coverage gains and reductions in national health spending, critics contend that bringing private insurer payments closer to Medicare rates could threaten providers’ financial viability. Once the U.S. overcomes the immediate public health emergency, attention will likely return to underlying questions regarding provider payments, as well as their impact on health expenditures and out-of-pocket costs. To inform both discussions, this issue brief reviews the findings of 19 recent studies comparing Medicare and private health insurance payment rates for hospital care and physician services.
• On April 15, 2020, the Bipartisan Policy Center (BPC) published a report entitled, Integrating Care for Beneficiaries Eligible for Medicare and Medicaid: An Update and Policy Options. This is the first of two white papers on the integration of care for dual-eligible individuals. The purpose of this paper is to provide necessary background on this population of low-income Medicare beneficiaries. The paper discusses important demographics, eligibility for Medicare and Medicaid, covered services under each program, and the implications of being enrolled in both programs. It also discusses different types of integration of Medicare and Medicaid services, and how state and federal policymakers have worked to make the programs function better for those who are enrolled, what has worked, and what has not. The second white paper provides options for consideration by state and federal policymakers, as well as stakeholders representing consumers, providers, and plans. BPC will issue final recommendations in the summer of 2020 and is seeking comments on the second paper.

IV. Other Health Policy News

• On April 15, 2020, HHS, through HRSA, awarded $90 million for Ryan White HIV/AIDS Program recipients across the country to prevent, prepare for, and respond to COVID-19. This funding is provided by the CARES Act, which President Trump signed into law on Friday, March 27, 2020. This funding supports 581 Ryan White HIV/AIDS Program recipients across the country, including city/county health departments, health clinics, community-based organizations, state health departments, and AIDS Education and Training Centers, in their efforts to prevent or minimize the impact of this pandemic on people with HIV. More information about the awards can be found here.
• On April 15, 2020, CMS announced that Medicare will nearly double payment for certain lab tests that use high-throughput technologies to rapidly diagnose large numbers of COVID-19 cases. Medicare will pay the higher payment of $100 for COVID-19 clinical diagnostic lab tests making use of high-throughput technologies developed by the private sector that allow for increased testing capacity, faster results, and more effective means of combating the spread of the virus. High-throughput lab tests can process more than two hundred specimens a day using highly sophisticated equipment that requires specially trained technicians and more time-intensive processes to assure quality. Medicare will pay laboratories for the tests at $100 effective April 14, 2020, through the duration of the COVID-19 national emergency. More information about this decision can be found here.
• On April 16, 2020, President Trump and the White House COVID-19 Taskforce released a plan for reopening America’s economy. The plan, entitled Guidelines for Opening Up America Again, is a three-phased approach based on the advice of public health experts to help states to reopen amid the COVID-19 pandemic. The guidance does not lay out a specific timeline for reopening, but instead provides a set of criteria for local leaders to use in making decisions to reopen their state economies. President Trump and the White House COVID-19 Taskforce emphasized that reopening the nation’s economy will occur in a stepwise fashion, as some areas of the country are experiencing the COVID-19 outbreak more severely than other areas. More information and a link to the full guidelines can be found here.

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