Below is Alston & Bird’s Health Care Week in
Review, which provides a synopsis of the latest news in health
care 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, HHS distributed $482 million in PRF payments and
announced $1.5 billion for State Opioid Response (SOR) grants. Read
more about these actions and other news below.
I. Regulations, Notices & Guidance
- On May 16, 2022, the Department of Health and Human Services
(HHS) issued a request for information entitled, 2022 HHS Environmental Justice Strategy and
Implementation Plan Draft Outline; Comment Period
Extended. HHS would like to identify priority actions and
strategies to best address environmental injustices and health
inequities for people of color, disadvantaged, vulnerable,
low-income, marginalized, and indigenous populations. With the
engagement of and input from the public, the 2022 Environmental
Justice Strategy and Implementation Plan will serve as a guide to
confront environmental and health disparities and implement a
multifaceted approach that will serve vulnerable populations and
communities disproportionately impacted by environmental burdens.
To be assured consideration, comments must be received no later
than midnight Eastern Time (ET) on June 18, 2022. - On May 16, 2022, the Food and Drug Administration (FDA) issued
final guidance entitled, Infant Formula Enforcement Discretion Policy:
Guidance for Industry. FDA is issuing this guidance
document to help increase the supply of infant formula in the
United States. FDA intends to temporarily exercise enforcement
discretion with respect to certain requirements for infant formulas
that may not comply with certain statutory and regulatory
requirements and is seeking information from manufacturers
regarding the safety and nutritional adequacy of their products.
This guidance document is intended to explain factors that FDA
intends to consider in making case-by-case determinations about
whether to exercise enforcement discretion to allow the
introduction into interstate commerce (including importation) of
infant formula that is safe and nutritionally adequate, but that
may not comply with all statutory and regulatory requirements. The
guidance is also intended to advise infant formula manufacturers
about the type of information to provide to FDA, if they would like
FDA to consider whether to exercise enforcement discretion with
regard to particular products. - On May 17, 2022, FDA issued final guidance entitled, Safety Considerations for Container Labels and
Carton Labeling Design to Minimize Medication Errors; Guidance for
Industry; Availability. The guidance focuses on safety
aspects of the container label and carton labeling design for human
prescription drug and biological products. The guidance provides
sponsors of new drug applications (NDAs), biologics license
applications (BLAs), abbreviated new drug applications (ANDAs), and
prescription drugs marketed without an approved NDA or ANDA with a
set of principles and recommendations for ensuring that critical
elements of product container labels and carton labeling are
designed to promote safe dispensing, administration, and use of the
product. - On May 17, 2022, FDA issued final guidance entitled, Assessing User Fees Under the Generic Drug User
Fee Amendments of 2017; Guidance for Industry;
Availability. This guidance provides stakeholders
information regarding the implementation of the Generic Drug User
Fee Amendments of 2017 (GDUFA II) and policies and procedures
surrounding its application. This guidance is finalizing FDA’s
draft guidance for industry “Assessing User Fees Under the
Generic Drug User Fee Amendments of 2017,” published in
November 2019. - On May 18, 2022, the Health Resources and Services
Administration (HRSA) issued a notice entitled, Criteria for Determining Maternity Care Health
Professional Target Areas. HRSA is directed to identify
Maternity Care Target Areas (MCTAs), or geographic areas within
health professional shortage areas that have a shortage of
maternity care health professionals, for the purpose of providing
maternity health care assistance to such health professional
shortage areas. HRSA solicited feedback on proposed criteria in
September 2021. This notice summarizes and responds to the comments
received during the 60-day comment period and presents the final
criteria which will be used to identify and score MCTAs. - On May 18, 2022, the Centers for Disease Control and Prevention
(CDC) issued a notice entitled, Solicitation of Nominations for Appointment to
CDC’s Advisory Committee to the Director (ACD) Data and
Surveillance Workgroup (DSW); Re-opening of Solicitation
Period. The establishment and formation of the DSW is to
provide input to the ACD on agency-wide activities related to the
scope and implementation of CDC’s data modernization strategy
across the agency, ultimately playing a key role in the
agency’s work with public health, healthcare, and academic and
private sector partners and with the promotion of equity. DSW
members will serve terms ranging from six months to one year and be
required to attend DSW meetings approximately one to two times per
month (virtually or in person), and contribute time between
meetings for research, consultation, discussion, and writing
assignments. - On May 19, 2022, FDA issued a notice entitled, Medical Devices; 510(k) Sterility Change Master
File Pilot Program. The 510(k) Sterility Pilot Program is
voluntary and intends to give interested companies that terminally
sterilize single-use devices using certain sterilization methods a
pathway to submit a Master File for FDA’s review. FDA will
accept a Master File into the 510(k) Sterility Pilot Program when
it determines, among other things, that there is not a likelihood
that switching from a fixed chamber ethylene oxide (EtO)
sterilization method to the sterilization method described in the
Master File could significantly affect the safety or effectiveness
of a 510(k)-cleared device that meets the product definition in the
Master File. - On May 19, 2022, FDA issued draft guidance entitled, Risk Management Plans To Mitigate the Potential
for Drug Shortages; Draft Guidance for Industry; Availability;
Agency Information Collection Activities; Proposed Collection;
Comment Request. This draft guidance is intended to help
stakeholders develop, maintain, and implement, as appropriate, risk
management plans (RMPs) to proactively assist in the prevention of
human drug product and biological product shortages. This draft
guidance recommends a framework and factors to consider that
stakeholders can use to develop RMPs. This draft guidance is
relevant for all stakeholders, including those with oversight and
control responsibilities for drug quality and contract
establishments, and for manufacturers of active pharmaceutical
ingredients (APIs), approved or licensed drug and biological
products, and drug products marketed without an application. - On May 19, 2022, FDA issued draft guidance entitled, Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry; Availability. The guidances
provide product-specific recommendations on, among other things,
the design of bioequivalence (BE) studies to support abbreviated
new drug applications (ANDAs). - On May 20, 2022, FDA issued a proposed rule entitled, Current Good Manufacturing Practice,
Certification, Postmarketing Safety Reporting, and Labeling
Requirements for Certain Medical Gases. FDA is proposing
new regulations that would amend the requirements concerning
current good manufacturing practice (CGMP) and post-marketing
safety reporting that apply to certain medical gases. FDA further
proposes to establish regulations regarding certification of
designated medical gases and amend the labeling regulations that
apply to certain medical gases. This action, if finalized, will
clarify the regulatory obligations of entities that manufacture,
process, pack, label, or distribute certain medical gases, as well
as reduce regulatory burden in this area. This proposed rule is
intended to establish requirements that are more specifically
tailored to the medical gas industry.
Event Notices
- June 6, 2022: The National
Institutes of Health (NIH) announced a public meeting of the National
Advisory Allergy and Infectious Diseases Council. The agenda will
include reports from the Institute Director, the Division Director,
and Division Staff. - June 6, 2022: NIH announced a public meeting of the AIDS
Research Advisory Committee. The agenda will include a report from
the Division Director and Division Staff. - June 7, 2022: NIH announced a public meeting of the National
Arthritis and Musculoskeletal and Skin Diseases Advisory Council.
The agenda will include a discussion of program policies and
issues. - June 14, 2022: FDA announced a public meeting of the Science
Board to the Food and Drug Administration Advisory Committee. The
Board will consider challenges in evaluating the safety of dietary
supplement and food ingredients with predicted pharmacological
activity, utilizing cannabinoids as a case study. The Board will
also hear about FDA’s enhanced efforts to spur the development,
qualification, and adoption of new alternative methods for
regulatory use that can replace, reduce, and refine animal testing
and have the potential to provide both more timely and more
predictive information to accelerate product development and
enhance emergency preparedness. The Board will also hear about
FDA’s efforts to ensure optimal organization, infrastructure,
and expertise for data science efforts in alignment with its
regulatory scope and evidence-based decision making, in support of
FDA’s public health priorities. - June 17, 2022: NIH announced a public meeting of the National
Advisory Eye Council. The agenda will include the presentation of
the National Eye Institute (NEI) Director’s report, discussion
of NEI programs, and concept clearances. - June 21-22, 2022: The Substance
Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center
for Substance Abuse Prevention’s (CSAP) Drug Testing Advisory
Board (DTAB). The agenda will include a discussion of the Mandatory
Guidelines for Federal Workplace Drug Testing Programs, updates on
the Drug Free Workplace Program as well as updates from the
Department of Transportation, the Nuclear Regulatory Commission, a
presentation by Dr. Barry Sample on Workforce Drug Testing for
Marijuana in 2021, and a presentation by Dr. Svante Vikingsson on
Hydroxy Cocaine and Cocaine Ratios in Hair. - September 12-13, 2022:
HHS announced a public meeting of the
Presidential Advisory Council on Combating Antibiotic-Resistant
Bacteria (PACCARB). The agenda will be dedicated to a One Health
anti-microbial resistance (AMR) and Pandemic Preparedness Policy
Workshop with the goal of identifying key issues and critical
policy gaps through a series of facilitated discussions examining a
hypothetical large-scale disease outbreak scenario based on
historic examples and estimates of future AMR outbreaks.
II. Congressional Hearings
U.S. House of Representatives
- On May 17, 2022, the House Committee on Oversight and Reform
Select Subcommittee on the Coronavirus Crisis held a hearing
entitled, Underpaid, Overworked, and Underappreciated:
How the Pandemic Economy Disproportionately Harmed Low-Wage Women
Workers. Witnesses present included: Ms. Mary Katharine
Ham, CNN Commentator and Author; Dr. C. Nicole Mason, President
& Chief Executive Officer, Institute for Women’s Policy
Research; Ms. Cynthia Murray, Fitting Department Associate,
Walmart; Dr. Yana van der Meulen Rodgers, Professor of Labor
Studies and Employment Relations, Faculty Director, Center for
Women and Work, on behalf of Rutgers University; and Ms. Vicki
Shabo, Senior Fellow – Paid Leave Policy and Strategy, Better Life
Lab, New America. - On May 18, 2022, the House Committee on the Judiciary held a
hearing entitled, Revoking Your Rights: The Ongoing Crisis in
Abortion Care Access. Witnesses present included: Ms.
Aimee Arrambide, Executive Director, Avow Texas; Ms. Catherine
Glenn Foster, President & CEO, Americans United for Life; Ms.
Michele Bratcher Goodwin, Chancellors Professor of Law, University
of California, Irvine; and Dr. Yashica Robinson, At-Large Member,
Board of Directors, Physicians for Reproductive Health. - On May 18, 2022, the House Committee on Homeland Security
Subcommittee on Border Security, Facilitation, and Operations held
a hearing entitled, Examining the Department of Homeland
Security’s (DHS) Efforts to Combat the Opioid
Epidemic. Witnesses present included: Mr. Brian Sulc,
Executive Director, Transnational Organized Crime Mission Center,
Office of Intelligence & Analysis, U.S. Department of Homeland
Security; Mr. Pete Flores, Executive Assistant Commissioner, Office
of Field Operations, U.S. Customs & Border Protection, U.S.
Department of Homeland Security; and Mr. Steve Cagan, Assistant
Director for Countering Transnational Organized Crime, Homeland
Security Investigations, U.S. Immigration & Customs
Enforcement, U.S. Department of Homeland Security. - On May 18, 2022, the House Committee on Energy & Commerce
held a markup of six bills. Legislation
discussed included: H.R. 7667, the Food and Drug
Amendments of 2022, H.R. 7666, the Restoring Hope for
Mental Health and Well-Being Act of 2022, H.R.
7233, the Keeping Incarceration Discharges Streamlined for
Child and Accommodating Resources in Education (KIDS CARES)
Act, H.R. 623, the Gabriella Miller Kids First
Research Act 2.0, H.R. 3771, the South Asian Heart
Health Awareness Act of 2021, and H.R. 5585,
the Advanced Research Project Agency-Health (ARPA-H)
Act. All six bills, as amended, were ordered reported
favorably to the House. - On May 19, 2022, the House Committee on Appropriations
Subcommittee on Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies held a hearing
entitled, Fiscal Year 2023 Budget Request for the Food
and Drug Administration. Witnesses present included: The
Honorable Robert M. Califf, Commissioner of Food and Drugs, Food
and Drug Administration.
U.S. Senate
- On May 17, 2022, the Senate Committee on Appropriations
Subcommittee on Labor, Health and Human Services, Education, and
Related Agencies held a hearing entitled, A Review of the President’s FY 2023
Funding Request and Budget Justification for the National
Institutes of Health. Witnesses present included, Dr.
Lawrence Tabak, Acting Director, National Institutes of Health; Dr.
Anthony Fauci, Director, National Institute of Allergy and
Infectious Diseases; Dr. Gary Gibbons, Director, National Heart,
Lung, and Blood Institute; Dr. Joshua Gordon, Director, National
Institute of Mental Health; Dr. Richard Hodes, Director, National
Institute on Aging; and Dr. Nora Volkow, Director, National
Institute on Drug Abuse. - On May 18, 2022, the Senate Committee on Health, Education,
Labor, and Pensions held a hearing entitled, Cybersecurity in the Health and Education
Sectors. Witnesses present included: Ms. Denise Anderson,
President and CEO, Health Information Sharing and Analysis Center;
Mr. Joshua Corman, Founder, I Am The Cavalry; Ms. Amy McLaughlin,
Cybersecurity Program Director, Consortium of School Networking;
and Ms. Helen Norris, Vice President and Chief Information Officer,
Chapman University. - On May 19, 2022, the Senate Special Committee on Aging held a
hearing entitled, Mental Health Care for Older Adults: Raising
Awareness, Addressing Stigma, and Providing Support.
Witnesses present included: Dr. Erin E. Emery-Tiburcio, Ph.D.,
ABPP, Co-Director, Rush Center for Excellence in Aging; Dr. Kenneth
M. Rogers, M.D., MSPH, MMM, State Director, South Carolina
Department of Mental Health; Ms. Kimberly Williams, President and
CEO, Vibrant Emotional Health; and Mr. Jim Klasen, Certified Older
Adult Peer Specialist (COAPS) Facilitator.
III. Reports, Studies & Analyses
- On May 16, 2022, KFF published an issue brief entitled, State Actions to Address Nursing Home Staffing
During COVID-19. This issue brief summarizes federal and
state standards related to nursing home staffing prior to COVID-19
and builds on existing information by identifying changes to state
minimum staffing requirements adopted since the onset of the
COVID-19 pandemic. KFF also examined state legislative and
regulatory actions since the onset of the pandemic that directly
affect worker wages and training requirements. - On May 16, 2022, the Congressional Budget Office published a
report entitled, Budgetary Effects of a Policy That Would Lower
the Age of Eligibility for Medicare to 60. In this report,
CBO discusses an estimate of the federal budgetary costs of a
policy that would lower the age of eligibility for Medicare,
largely reflecting current program rules for people who would be
newly eligible. The estimate was prepared in conjunction with the
staff of the Joint Committee on Taxation (JCT). This report also
describes the resulting changes in the number of people with health
insurance coverage and the sources of that coverage.On May 17,
2022, the RAND Corporation published a report entitled, Prices Paid to Hospitals by Private Health
Plans. This report uses medical claims data from a large
population of privately insured individuals, including hospitals
and other facilities from across the United States, and allows an
easy comparison of hospital prices using a single metric. The
report found that in 2020, across all hospital inpatient and
outpatient services (including both facility and related
professional charges), employers and private insurers paid 224
percent of what Medicare would have paid for the same services at
the same facilities. - On May 17, 2022, the RAND Corporation published a report
entitled, Prices Paid to Hospitals by Private Health
Plans. This report uses medical claims data from a large
population of privately insured individuals, including hospitals
and other facilities from across the United States, and allows an
easy comparison of hospital prices using a single metric. The
report found that in 2020, across all hospital inpatient and
outpatient services (including both facility and related
professional charges), employers and private insurers paid 224
percent of what Medicare would have paid for the same services at
the same facilities. - On May 19, 2022, KFF published a report entitled, Medicaid Coverage of Pregnancy-Related
Services: Findings from a 2021 State Survey. The survey
asked states about the specific maternity services they cover. The
range of pregnancy-related services that states cover is shaped by
many factors, and states have significant latitude to set income
eligibility levels, define specific maternity care services, and
apply utilization controls such as prior authorization and
preferred drug lists (PDL). This report presents detailed survey
findings from 41 states and DC on fee-for-service coverage and
utilization limits for Prenatal care and Delivery, Fertility
Services, Counseling and Support Services, Substance Use Disorder
Services, and Breastfeeding Supports and Postpartum Care.
IV. Other Health Policy News
- On May 16, 2022, HHS announced a funding opportunity of nearly
$15 million for a three-year federal grant to establish a SAMHSA
program that will strengthen the delivery of behavioral health care
to residents of nursing homes and other long-term care facilities.
Funded by the Centers for Medicare & Medicaid Services (CMS),
this program will establish a Center of Excellence for Building
Capacity in Nursing Facilities to Care for Residents with
Behavioral Health Conditions (Center for Excellence). The Center of
Excellence is expected to improve overall health care in nursing
homes and other long-term care facilities by providing direct
consultation to staff to increase understanding, improve awareness,
reduce stigmatization, and build knowledge and skills for effective
resident care. The program will be funded with CMS’ Civil Money
Penalty (CMP) funds, which come from collected CMPs that are
imposed against nursing homes and other long-term care facilities
when they are not in substantial compliance with one or more
Medicare and Medicaid program participation requirements for
long-term care facilities. More information on this funding can be
found here. - On May 17, 2022, HHS announced a nearly $3.5 million
five-year grant opportunity to develop a Center of Excellence,
advancing behavioral health care for Asian American, Native
Hawaiian, and Pacific Islander (AANHPI) communities while reducing
behavioral health-related disparities. The AANHPI
Behavioral Health Center of Excellence will promote culturally
and linguistically appropriate behavioral health information and
practices; establish a steering committee to identify emerging
issues; and provide training, technical assistance, and
consultation to practitioners, educators, and community
organizations. Training topics include addressing mental health
impacts caused by unconscious bias and hate against AANHPI
communities. The Center of Excellence will also develop accessible,
public-facing infographics and other materials that address
behavioral health, including those that provide data disaggregated
by race and ethnicity, as well as best practices for improving
engagement and retention of AANHPI behavioral health professionals.
More information on this funding can be found here. - On May 18, 2022, HHS announced its first-ever behavioral health
Recovery Innovation Challenge. The goal of this challenge is to
identify innovations developed by peer-run or community-based
organizations, and entities that may partner with them—such
as local or state governments, health systems, hospitals, or health
plans—that advance recovery. As part of this challenge,
participants are encouraged to share details about the practices
they are using to advance recovery and demonstrate how these
practices have: 1) expanded upon SAMHSA’s definition of
recovery, or 2) helped them overcome challenges in incorporating
recovery into their behavioral health services or systems. SAMHSA
is using the challenge to directly engage with a larger and more
diverse number of organizations, including groups providing
recovery services and supports at all levels in the continuum of
care for behavioral health. More information on this opportunity
can be found here. - On May 18, 2022, HHS announced $2 million in funding to
establish a national center of excellence on social media and
mental wellness. The purpose of the CoE will be to develop and
disseminate information, guidance, and training on the
impact—including benefits and risks—that social media
use has on children and youth, especially the risks to their mental
health. This center of excellence will also examine clinical and
social interventions that can be used to mitigate the risks. The
center of excellence on Social Media and Mental Wellness will focus
on three priorities: 1) education and resources around the risks
and benefits of social media use for children and youth; 2)
culturally and linguistically appropriate technical assistance
focusing on active learning, consultation, and support on how to
best assist children and youth when interfacing with the digital
world in a way that enhances their mental health while reducing
harm; and 3) best practices and research updates. More information
on this funding can be found here. - On May 18, 2022, HRSA announced the distribution of more than
$482 million from previously-appropriated funding for the Provider
Relief Fund (PRF) in Phase 4 General Distribution payments. These
payments are being issued to nearly 2,300 providers across the U.S.
HRSA will continue to distribute additional PRF Phase 4 General
Distribution payments as it processes remaining applications from
providers. Including these payments, HRSA has distributed a total
of nearly $14 billion in PRF Phase 4 payments to approximately
88,000 providers across the U.S. In addition to these PRF payments,
HRSA also has distributed a total of $7.9 billion from funding
appropriated for American Rescue Plan (ARP) Rural payments to more
than 46,000 providers since November 2021. More information on this
funding can be found here. - On May 18, 2022, the Centers for Medicare & Medicaid
Services (CMS) announced a series of monthly calls for health care
stakeholders related to the unwinding of the Public Health
Emergency (PHE) that was declared in response to the COVID-19
pandemic. The first call will be held on May 25, 2022. Registration
information for the CMS monthly calls can be found here. Previously, in December 2021, HHS
Secretary Xavier Becerra pledged to provide a 60-day notice before
any termination or expiration of the declaration of a PHE. Notably,
HHS would have been expected to announce the 60-day notice of
termination of the PHE by May 16, 2022 in advance of the expiration
of the current PHE on July 15, 2022. However, to date, HHS has not
announced a date for ending the PHE, indicating that HHS expects to
extend the PHE beyond July 15, 2022. - On May 19, 2022, HHS announced a State Opioid Response (SOR)
grant funding opportunity that will provide nearly $1.5 billion to
states and territories to help address the nation’s opioid
addiction and overdose epidemic. The SOR grant program provides
formula funding to states and territories for increasing access to
FDA-approved medications for the treatment of Opioid Use Disorder
(OUD), and for supporting prevention, harm reduction, treatment,
and recovery support services for OUD and other concurrent
substance use disorders (SUD). The SOR program also supports care
for stimulant misuse and use disorders, including for cocaine and
methamphetamine. The SOR program helps reduce overdose deaths and
close the gap in treatment needs across America by giving states
and territories flexibility in funding evidence-based practices and
supports across different settings to meet local community needs.
More information on this funding can be found here.
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