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 $1.75 billion in PRF Phase 4 payments and announced $226.5 million for the Community Health Worker Training Program. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On April 11, 2022, the Food and Drug Administration (FDA)
issued final guidance entitled, Orthopedic Fracture Fixation Plates -
Performance Criteria for Safety and Performance Based Pathway:
Guidance for Industry and Food and Drug Administration
Staff. This guidance provides performance criteria for
Orthopedic Fracture Fixation Plates in support of the Safety and
Performance Based Pathway. Under this framework, submitters
planning to submit a 510(k) using the Safety and Performance Based
Pathway for Orthopedic Fracture Fixation Plates will have the
option to use the performance criteria proposed in this guidance to
support substantial equivalence, rather than a direct comparison of
the performance of the subject device to that of a predicate
- On April 11, 2022, FDA issued final guidance entitled, Surgical Sutures - Performance Criteria for
Safety and Performance Based Pathway: Guidance for Industry and
Food and Drug Administration Staff. This guidance provides
performance criteria for surgical sutures in support of the Safety
and Performance Based Pathway. Under this framework, submitters
planning to submit a 510(k) using the Safety and Performance Based
Pathway for surgical sutures will have the option to use the
performance criteria provided in this guidance to support
substantial equivalence, rather than a direct comparison of the
performance of the subject device to that of a predicate
- On April 11, 2022, the Centers for Medicare & Medicaid
Services (CMS) issued a proposed rule entitled, Medicare Program; Prospective Payment System
and Consolidated Billing for Skilled Nursing Facilities; Updates to
the Quality Reporting Program and Value-Based Purchasing Program
for Federal Fiscal Year 2023; Request for Information on Revising
the Requirements for Long-Term Care Facilities to Establish
Mandatory Minimum Staffing Levels. This proposed rule
would update: payment rates; forecast error adjustment; diagnosis
code mappings; the Patient Driven Payment Model (PDPM) parity
adjustment, the SNF Quality Reporting Program (QRP), SNF
Value-Based Purchasing (VBP) Program. It also proposes to establish
a permanent cap policy. This proposed rule also includes a request
for information related to long-term care (LTC) facilities. CMS
requests comments on these proposals as well as on related subjects
and announces the application of a risk adjustment for the SNF
Readmission Measure for COVID-19 beginning in FY 2023.
- On April 12, 2022, FDA issued final guidance entitled, Performance Criteria for Safety and Performance
Based Pathway; Guidance for Industry and Food and Drug
Administration Staff; Availability. These device-specific
guidance documents provide performance criteria for premarket
notification (510(k)) submissions to support the optional Safety
and Performance Based Pathway, as described in the guidance
entitled "Safety and Performance Based Pathway." As
described in that guidance, substantial equivalence is rooted in
comparisons between new devices and predicate devices.
- On April 12, 2022, NIH issued a notice entitled, Government-Owned Inventions; Availability for
Licensing. The invention, humanized murine monoclonal
antibodies that neutralize type-1 interferon (IFN) activity, is
owned by an agency of the U.S. Government and is available for
licensing to achieve expeditious commercialization of results of
federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market
coverage for companies and may also be available for
- On April 13, 2022, FDA issued draft guidance entitled, Considerations for Waiver Requests for pH
Adjusters in Generic Drug Products Intended for Parenteral,
Ophthalmic, or Optic Use; Draft Guidance for Industry;
Availability. This guidance is intended to assist
abbreviated new drug application (ANDA) applicants that reference a
drug product intended for parenteral, ophthalmic, or optic use in
seeking approval of a drug that is qualitatively (Q1) different or
quantitatively (Q2) different from the reference listed drug (RLD)
with respect to the pH adjuster(s). This draft guidance describes
how FDA intends to evaluate a request for a waiver of Agency
requirements, for a Q1 or Q2 difference in pH adjuster, including
recommendations on the type of information to provide in support of
such a waiver request. This draft guidance also includes
recommendations on the timing and process for submitting such
- On April 13, 2022, FDA issued draft guidance entitled, Diversity Plans to Improve Enrollment of
Participants From Underrepresented Racial and Ethnic Populations in
Clinical Trials; Draft Guidance for Industry;
Availability. The purpose of this guidance is to provide
recommendations to sponsors developing medical products on the
approach for developing a Race and Ethnicity Diversity Plan
(referred to as the "Plan") to enroll adequate numbers of
participants in clinical trials from underrepresented racial and
ethnic populations in the U.S.
- On April 14, 2022, the Agency for Healthcare Research and
Quality (AHRQ) issued a notice entitled, Request for Information: AHRQ's Proposed
Patient-Centered Outcomes Research Trust Fund Strategic Framework;
Extension of Comment Period. In the Federal Register of
February 18, 2022, AHRQ announced that it was seeking input from
the public on its proposed strategic framework for AHRQ's
Patient-Centered Outcomes Research Trust Fund investments. This
notice extends the comment period 35 days from April 19, 2022, to
May 24, 2022.
- On April 14, 2022, FDA issued final guidance entitled, Bioavailability Studies Submitted in NDAs or
INDs--General Considerations; Guidance for Industry;
Availability. This guidance provides recommendations to
sponsors planning to include bioavailability (BA) information for
drug products in investigational new drug applications (INDs), new
drug applications (NDAs), and NDA supplements. This guidance
finalizes the draft guidance of the same title issued on February
- On April 14, 2022, FDA issued draft guidance entitled, Celiac Disease: Developing Drugs for Adjunctive
Treatment to a Gluten-Free Diet; Draft Guidance for Industry;
Availability. This draft guidance addresses FDA's
recommendations regarding clinical trials for drugs being developed
for the treatment of celiac disease as an adjunct to a gluten-free
diet in adults.
- On April 15, 2022, NIH issued a notice entitled, Government-Owned Inventions; Availability for
Licensing. The invention, Novel Methods of MHC-I - LILRB
Checkpoint Inhibition, is owned by an agency of the U.S. Government
and is available for licensing to achieve expeditious
commercialization of results of federally funded research and
development. Foreign patent applications are filed on selected
inventions to extend market coverage for companies and may also be
available for licensing.
- On April 15, 2022, NIH issued a notice entitled, Government-Owned Inventions; Availability for Licensing. The invention, Expression of Prefusion-stabilized Spike S Glycoprotein of SARS CoV-2 from Avian Paramyxovirus Type 3 (APMV3), is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
- April 20, 2022: The Centers for
Disease Control and Prevention (CDC) announced a public meeting of the Advisory
Committee on Immunization Practices (ACIP). The agenda will include
discussions on COVID-19 vaccine booster doses. A recommendation
vote(s) is scheduled.
- May 10, 2022: NIH announced a public meeting of the National
Advisory Council on Drug Abuse. The agenda will include
presentations and other business of the Council.
- May 12-13, 2022: The Health
Resources and Services Administration (HRSA) announced a public meeting of the Advisory
Committee on Heritable Disorders in Newborns and Children (ACHDNC).
Agenda items include the following: a final evidence-based review
report on the guanidinoacetate methyltransferase (GAMT) deficiency
condition nomination for possible inclusion on the Recommended
Uniform Screening Panel (RUSP). Following this report, the ACHDNC
expects to vote on whether to recommend the Secretary add GAMT
deficiency to the RUSP; An update on the Krabbe disease condition
nomination; A possible vote on whether to move Krabbe disease
forward to full evidence-based review; A presentation on
homocystinuria newborn screening status; and a presentation on the
Newborn Screening Family Education Program.
- May 18, 2022: NIH announced a public meeting of the National
Institute of Dental & Craniofacial Research (NIDCR). The agenda
will include the Report of the Director, NIDCR and concept
- May 19-20, 2022: NIH announced a public meeting of the Council
of Councils. The agenda will include NIH Program Updates;
Scientific Talks and Other Business of the Committee.
- May 23-24, 2022: NIH announced a public meeting of the National
Advisory Council on Minority Health and Health Disparities. The
agenda will include administrative matters, a director's
report, presentations, and other business of the Council.
- June 9-10, 2022: FDA announced a public meeting of the
Cellular, Tissue and Gene Therapies Advisory Committee. The morning
session of June 9, 2022 will include presentations of the
effectiveness and product-specific safety results from the clinical
trials in BLA 125755. The afternoon session will include
presentations of safety concerns relevant to both products,
followed by committee discussion of BLA 125755. On June 10, 2022,
the morning session will include presentations of the effectiveness
and product-specific safety results from the clinical trials in BLA
125717. The afternoon session will include committee discussion of
- June 23, 2022: CMS announced a public meeting for the
Medicare program entitled, Medicare Program; Public
Meeting on June 23, 2022 Regarding New and Reconsidered Clinical
Diagnostic Laboratory Test Codes for the Clinical Laboratory Fee
Schedule for Calendar Year 2023. This public meeting is being
held to receive comments and recommendations (including data on
which recommendations are based) on the appropriate basis for
establishing payment amounts for new or substantially revised
Healthcare Common Procedure Coding System codes being considered
for Medicare payment under the Clinical Laboratory Fee Schedule
(CLFS) for calendar year (CY) 2023. This meeting also provides a
forum for those who submitted certain reconsideration requests
regarding final determinations made last year on new test codes and
for the public to provide comment on the requests.
- July 12-13, 2022: FDA announced a public meeting of the Patient
Engagement Advisory Committee. On July 12 and 13, 2022, the
Committee will discuss and make recommendations on the topic of
"Augmented Reality (AR) and Virtual Reality (VR) Medical
Devices." AR/VR devices are increasingly applied to healthcare
settings across the patients' care continuum. From diagnostics
to clinical decision making, to surgical support, and to directly
treating patients, AR/VR devices are used across multiple medical
specialties. These devices have novel attributes and considerations
for the end users that impact FDA's evaluation of the
device's safety and effectiveness.
- July 18-19, 2022: CMS announced a public meeting of the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests. The agenda will include discussion on the Calendar Year (CY) 2023 Clinical Laboratory Fee Schedule (CLFS) new and reconsidered test codes and other CY 2023 CLFS issues designated in the Panel's charter.
II. Reports, Studies & Analyses
- On April 12, 2022, the Kaiser Family Foundation (KFF) published
an issue brief entitled, Many Workers, Particularly at Small Firms,
Face High Premiums to Enroll in Family Coverage, Leaving Many in
the 'Family Glitch'. This analysis uses the KFF
Employer Health Benefits Survey (EHBS) to look at the shares of workers that
might pay significant amounts to enroll families and how these
shares vary across firms. These are the workers most likely to
benefit from a fix to the family glitch.
- On April 14, 2022, the Congressional Budget Office (CBO) gave a presentation entitled, Variation in Prices for Hospitals' Services. The presentation covered the variation among states in prices for hospitals' inpatients services, inpatient price variation within metropolitan areas, the relationship between hospitals' wages and commercial insurers' prices for inpatient services, and concentration in hospital markets and commercial insurers' prices.
III. Other Health Policy News
- On April 12, 2022, HHS Secretary Xavier Becerra renewed the
determination that a public health emergency (PHE) exists. The full
notice of the renewal can be found here.
- On April 13, 2022, HRSA announced more than $1.75 billion in
Provider Relief Fund (PRF) payments to 3,680 providers across the
country. With this disbursement, HRSA has distributed approximately
$13.5 billion from the PRF to nearly 86,000 providers and nearly
$7.5 billion in American Rescue Plan (ARP) Rural
payments to more than 44,000 providers since November 2021.
Providers can use PRF payments received in the first half of 2022
to cover losses and expenses until June 30, 2023. With these latest
payments, approximately 92 percent of all Phase 4 applications have
been processed. Remaining applications require additional manual
review and HRSA is working to process them as quickly as possible.
More information on this funding can be found here.
- On April 13, 2022, CMS announced key actions to reduce maternal
morbidity and mortality. CMS is released more details about the
proposed "Birthing-Friendly" hospital designation
intended to drive improvements in maternal health outcomes. The new
designation would assist consumers in choosing hospitals that have
demonstrated a commitment to maternal health and the delivery of
high-quality maternity care. Additional information about the
initial requirements for the designation will be released in the
coming days as a part of the Hospital Inpatient Prospective Payment
System (IPPS) proposed rule. More information about this new
initiative can be found here.
- On April 13, 2022, HHS announced approximately $16 million to
strengthen Maternal, Infant, and Early Childhood Home Visiting
(MIECHV) Programs through seven awards supporting eight states.
These awards will advance data and technology innovations to
support positive maternal and child health outcomes in states and
communities and focus on addressing health disparities. In
addition, HRSA announced the availability of up to $9 million
through the State Maternal Health Innovation and Data Capacity
Program to expand the State Maternal Health Innovation and
Implementation Program. This program supports state-level
development and implementation of proven strategies to improve
maternal health and address maternal health disparities. The new
funding will continue to build state capacity to deliver
high-quality maternity care services, provide training for maternal
care clinicians, and enhance the quality of state-level maternal
health data through better collection, reporting and
analysis. The program will fund up to nine cooperative
agreements, and each will receive up to $1 million over five years.
More information on this funding can be found here.
- On April 15, 2022, HHS announced the availability of $226.5 million in American Rescue Plan funding to launch the Community Health Worker Training Program. This new program will increase the number of community health workers who play a critical role in connecting people to care, including COVID-19 care; mental health and substance use disorder prevention, treatment and recovery services; chronic disease care; and other important health services. More information on this funding can be found here.
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