Reproductive Health Care
APhA is committed to advancing equitable access to comprehensive reproductive health care for all patients. The association advocates for policies that ensure access to essential reproductive services and opposes legal actions against pharmacies and pharmacists who provide care within their scope of practice. APhA strives to ensure that pharmacists play a vital role in facilitating informed, patient-centered reproductive health care.
COVID-19 Advocacy
APhA's COVID-19 advocacy efforts
focus on maintaining the
flexibilities and authorities
extended to pharmacists by the
federal government, while continuing
to advocate for changes that will
allow pharmacists to utilize their
full expertise to care for patients.
The federal government is looking at
ways to improve access to care by
being more flexible about certain
requirements and expanding scope of
practice through new authorities
during the COVID-19 public health
emergency. Our current areas of
focus include immunizations,
testing, payment, compounding,
telehealth, and future pandemic
planning.
COVID-19 Test to Treat Access
APhA’s analysis of COVID-19 Test to
Treat locations, as of May 6, 2022,
demonstrates that underserved and
vulnerable communities do not have
equitable access to care in the
current program.
As hospitalization rates and deaths
from COVID-19 persist, the need to
quickly connect high-risk patients
who test positive for COVID-19 to
lifesaving treatments remains
essential.
Pharmacists’ Patient Care Services
Pharmacists’ patient care services are not included in key sections of the Social Security Act (SSA), which determines eligibility for health care programs such as Medicare Part B. In the case of Medicare Part B, the omission of pharmacists’ patient care services limits Medicare beneficiaries’ access to pharmacists’ services in the outpatient setting. Pharmacists have demonstrated their value while playing a crucial role in COVID-19 pandemic response by being available and accessible as front-line health care professionals. APhA encourages Congress to pass legislation that recognizes pharmacists’ patient care services in Medicare Part B and as integral members of the health care team to provide patients with access to and coverage for our quality patient care services.
Pharmacist and Pharmacy Payment
Reform
The pharmacy reimbursement and drug
pricing scheme in the U.S. has grown
out of control, with misaligned
incentives that neither benefit the
patient nor lead to better health
outcomes. These misalignments are
causing pharmacies across the
country to shut their doors, leaving
patients without access to their
local pharmacies. APhA supports
transparency and accountability in
reimbursement and pricing and is
thus concentrating policy efforts to
1) support pharmacists’ ability to
focus on patient care and to be
appropriately paid for these
services and 2) reform pharmacy
payment and PBMs’ actions and
activities that are disrupting the
pharmacy ecosystem. Recent advocacy
and
legal action
led to CMS issuing a final rule that
eliminates harmful retroactive
direct and indirect remuneration
(DIR) fees.
Other Improvements to Medicare
As scientific innovation leads to
medications that are exponentially
more complex, we believe that
pharmacists, as the medication
experts, need to be key players on
patient health teams. APhA advocates
for the expansion and enhancement of
the Medicare Part D Medication
Therapy Management (MTM) program.
Further, APhA supports CMS’s efforts
to increase patient access and
choice by requiring Part D plans and
pharmacy benefit managers (PBMs) to
contract with any pharmacy willing
to accept the PBM’s contractual
terms and conditions for network
participation (i.e. “any willing
pharmacy” requirement). In addition,
APhA will continue to advocate for
increased transparency regarding
Part D plans, including efforts to
provide beneficiaries with
up-to-date information about actual
access standards and cost-sharing
information.
Prescription Drug Misuse and Abuse
APhA supports legislative,
regulatory, and private sector
efforts that address prescription
drug abuse, misuse, and treatment.
We acknowledge that any effort must
balance the need for
patient/consumer access to
medications for legitimate medical
purposes with the need to prevent
diversion and abuse. Pharmacists’
knowledge, accessibility, and
expertise, puts them in a unique
position to help combat this
epidemic. APhA believes prescription
drug misuse and abuse that leads to
substance use disorder should be
addressed using multi-pronged
approach that includes
medication-assisted treatment,
abuse-deterrent formulations, access
to treatment, integrated
prescription drug monitoring
programs, guidelines, and access to
prescription drug take-back
receptacles and programs.
Biologics and Biosimilars
APhA strongly supports the
development of biologics and
biosimilars as well as state
biosimilar substitution practices
that mirror those for small-molecule
drugs unless science dictates
otherwise. APhA has advocated
against unique names and/or suffixes
for reference biologics and
biosimilars for reasons including
such distinction could contribute to
confusion regarding biosimilar
interchangeability.
Health Information Technology
APhA has continued our involvement
with standards development
organizations to ensure standards
are aligned with the needs and
interests of pharmacists who will be
using the technology. Through the
Pharmacy Health Information
Technology Collaborative, APhA works
with other pharmacy stakeholders to
address pharmacist services’ billing
and documentation codes,
communication standards, pharmacist
electronic health records, and
documentation codes and values sets
for use in the national electronic
health information exchanges for
pharmacy.
Compounding
APhA urges policymakers to defer to
existing state laws related to
traditional compounding, including
laws related to “office-use,” and
has asked FDA to clarify that its
guidance is not designed to infringe
on the practice of pharmacy as
historically regulated by the
states. APhA also remains concerned
that arbitrary limitations on the
out-of-state distribution of
compounded drug products may
adversely impact patient access to
medically-necessary medications.
Track and Trace (DSCSA)
APhA supports efforts to protect the
integrity of our Nation’s drug
supply. The
Drug Supply Chain Security Act of
2013 (DSCSA) outlines a stepwise
approach to construct an electronic,
interoperable system that identifies
and traces certain prescription
drugs down to the package level as
they move through the supply chain.
APhA will continue to advocate for
pharmacists’ interests as
requirements are established.
-
APhA comment letter to FDA on
DSCSA small dispenser
assessment
(May 2024)
-
APhA comments to FDA on Request
for Information and Comment on
Implementing Interoperable
Systems and Processes for DSCSA
Enhanced Drug Distribution
Security Requirements
(February 2024)
-
APhA NCPA DSCSA Small Business
Dispenser Assessment Comment
Letter FINAL
(September 2023)
-
APhA Joint Letter to FDA to
Request for Phased
Implementation of the Upcoming
DSCSA Requirements
(July 2023)
-
APhA Request for Enforcement
Discretion for DSCSA Small
Business Dispensers Letter
(December 2022)
-
Dispensers: What you should
know about DSCSA
(November 2021 APhA powerpoint)
-
DSCSA Resources for
Dispensers – a compilation of DSCSA
resources including checklists,
CPE courses, FAQs, podcasts,
presentations, publications, and
webinars
-
Pharmacies Must Comply With
Certain Track and Trace
Requirements, FDA Says (December 1, 2020, in
Pharmacy Today)
-
Locked on Pharmacy Podcast:
Track and Trace: Pharmacists New
Responsibilities to Combat
Counterfeit Drugs (January 7, 2021)
-
Q&As on dispenser
requirements, Pharmaceutical
Distribution Security
Alliance (October 2020)
-
FDA offers a free 45-minute
continuing education course for
pharmacists to help explain DSCSA
requirements and has a
pharmacist-specific page
regarding DSCSA
Cybersecurity
APhA stands ready to work with
policymakers to discuss lessons
learned from the Change Healthcare
cyberattack, and what’s needed to
implement these recommendations for
prevention, mitigation, emergency
preparedness and response, and
penalties to ensure this does not
happen again.