INTEGRATIVE HEALTHCARE POLICY
A YEAR IN REVIEW
Academy of Integrative Pain Management ceases operations
Joint Commission introduces new pain management standards
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FDA issues warning for unsubstantiated CBD claims, prioritizes regulation PAGE 23
Contents
INTEGRATIVE HEALTHCARE POLICY
A YEAR IN REVIEW
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Looking Back at 2019
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FDA cracks down on unapproved stem cell therapies
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ACAOM publishes complete Comprehensive Standards
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New representatives take leadership of Congressional Integrative Health and Wellness Caucus
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Academy of Integrative Pain Management ceases operations
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EAT-Lancet Commission recommends “planetary healthy diet” at United Nations meeting
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FDA steps up policing of dietary supplements
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Weil makes $15 million gift to UA Center for Integrative Medicine
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Idaho regulates naturopathic doctors
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AHA releases Clinical Practice Guidelines on Primary Cardiovascular Prevention
EDITORIAL Katherine Rushlau Editor krushlau@divcom.com
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WHO latest ICD includes Traditional Chinese Medicine
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Bill for chiropractic in Arizona Medicaid does not move forward
LEADERSHIP Faith Irek Digital Product Manager
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New Mexico governor signs naturopathic regulation, licensing bill into law
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HHS Pain Management Task Force finalizes recommendations
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World Health Organization defines “burnout” as official medical diagnosis
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MARKETING Kelcey Leshinski Marketing Coordinator SALES Carmella Perrone Sales Manager DESIGN Theresa Slusher Senior Production Designer EDITORIAL BOARD Kellie Blake, RDN, LD, IFNCP Carolina Brooks, ND, BA, IFMCP Melissa Carr, B.Sc., Dr.TCM Nancy Gahles, DC, CCH, RSHom(NA), OIM Gary Goldman, MD, FACOG, IFMC Julie Luzarraga, LICSW, DCSW Karen Malkin, NBC-HWC Bill Reddy, L.A.c., Dipl.Ac. Ken Sharlin, MD, MPH, IFMCP
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2019 Integrative Healthcare Policy | A Year in Review
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Trump signs executive order to make healthcare costs more transparent
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Joint Commission introduces new pain management standards
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Integrative health community endorses Social Determinants Accelerator Act
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JAMA commentary calls for more physician nutrition education
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Inspector General reports DEA slow to respond to opioid crisis
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FDA issues warning to for unsubstantiated CBD claims, prioritizes regulation
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Going Forward
FROM THE EDITOR
Integrative Healthcare Policy
Looking Back at 2019 THE HEALTHCARE INDUSTRY— and the laws and policies that regulate the system—has been changing rapidly over the past few years. At the demand of both patients and practitioners who advocate for a preventative, whole-person approach to care, the industry has started to shift away from the traditional “sick care” model and bring integrative medicine to the general public eye.
H
management have prompted yet another shift towards non-pharmacologic and integrative approaches. The time has never been better for integrative medicine to take center stage, and developments in integrative healthcare policy and regulation are reflective of this.
owever, a real shift to integrative healthcare
integrative healthcare, it did open doors for many
The purpose of this annual update is to summarize
requires not only awareness and acceptance,
integrative care providers to receive coverage for
the past year’s successes, challenges, and progress
their services.
in integrative healthcare policy on the national
but solid organizational, institutional, and policy change. This process historically includes
level. This includes key laws, actions, and other
standard-setting, self-regulation, and then
Additionally, Section 3502 recommended
influential statements by both federal government
governmental action..
healthcare teams include “doctors of chiropractic,
and quasi-governmental agencies. The focus is on
licensed complementary and alternative
practitioners and their patient practices, as well
In the early ‘90s, when the New England Journal
medicine practitioners.”; Section 4001 included
as nutrition and product-related regulations that
of Medicine published a special report revealing
integrative health as a focal point in its National
significantly affect integrative practitioners. In
more Americans (425 million) sought care from
Prevention Council; Section 5101 mandated a
addition, we do our best to outline any significant
“providers of unconventional therapy,” than
complementary and alternative medicine (CAM)
progress made on the state level, specifically
primary care physicians (388 million), stakeholders
workforce for the National Healthcare Workforce
regarding licensing, mandates, and inclusion in
started to pay more attention to the need for
Commission, though it was never funded; Section
state-specific legislation.
integrative care in the greater healthcare industry.
2301 allowed licensed midwives to be included as practitioners in birth centers; and Section 6301
As agents for change, it has never been more
More recently, the Affordable Care Act put
discussed patient-centered outcomes research,
important to remain at the forefront of this
integrative medicine in federal policy for the
and required advisory panels to include “experts in
bridging between conventional and integrative
first time. In Section 2706, which covered
integrative health,” and a licensed member of the
care. We hope you find this resource useful in your
nondiscrimination in healthcare, insurance plans
CAM professions to sit on its Board of Governors.
endeavors.
could not refuse participation in the plan or coverage for providers if they act within the scope
While much of the current healthcare system
EDITOR’S NOTE: For questions or comments, please
of their license or certification under applicable
in the U.S. remains uncertain, national health
e-mail Integrative Practitioner editor Katherine
state laws. While this does not explicitly call out
crises with both opioid use and chronic pain
Rushlau at krushlau@divcom.com.
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JANUARY 2019
FDA CRACKS DOWN ON UNAPPROVED STEM CELL THERAPIES Stem cell therapy seems an intriguing opportunity in integrative medicine, but in January, the U.S. Food and Drug Administration (FDA) cracked down on clinics that offer such treatment methods.
T
hought to treat or prevent chronic diseases
contaminated stem cell
and injuries, stem cell therapy, also known
treatments. The cases were
as regenerative medicine, involves implanting
traced back to Genetech
specialized cells into a person. For example, if a
Inc., which prompted a
person has heart disease, the cells could be injected
warning letter issued by the
into the heart muscle, and the healthy transplanted
FDA shortly after. Representatives from Genetech
announced a streamlined clinical trial process,
cells could then contribute to repairing defective
Inc. responded, noting they would take steps to
where clinics can team up on trials and pool their
heart muscle. A common form of this type of
regulate unapproved treatments.
patients to save time and money.
therapy is a bone marrow transplant. Scientists and bioethicists also expressed
The FDA is offering up to a 36-month grace period
Some clinics are performing fat-derived stem
concern, and in a paper published in the journal
for clinics to comply with its guidelines. Clinics
cell therapy, where a practitioner removes a
Perspectives in Biology and Medicine, authors found
can continue to operate on patients without
small amount of a person’s fat, processes it, and
that marketing claims across 716 stem cell clinics
clinical trials for now, but the FDA is monitoring
injects it back into them. This is thought to jump-
in the U.S. were misleading and, in some cases,
and warning patients to do their part to stay safe.
start the healing process. The therapy is not FDA-
dangerous.
approved, though hundreds of clinicians and
Practitioners performing these therapies argue
clinics across the U.S. offer fat-derived stem cell
The problem is misunderstanding what types of
that, even with the new process, clinical trials are
therapy, according to the Cell Surgical Network.
stem cells provide a platform for regenerating
expensive and can last for many years, which takes
muscle or rebuilding organs. Stem cells derived
their attention away from patient care.
In 2017, three FDA scientists published a report in
from embryos have this ability, known as
the New England Journal of Medicine noting that the
pluripotency. Adult stem cells do not have
lack of evidence is concerning. In May 2018, the
pluripotency, and to acquire pluripotency, adult
Department of Justice, on behalf of the FDA, sued
cells must be biologically reprogrammed. These
clinics in California and Florida for “experimenting
induced pluripotent stem cells allow doctors
on patients with misleading products.”
to treat serious disease like leukemia and other cancers in the blood and bone marrow.
Currently, the only stem cell therapy that is approved by the FDA is the bone marrow
Fat-derived stem cell therapy uses mesenchymal
transplant, where doctors use cells to treat
stem cells found in fat, which have limited function
autoimmune, neurologic, and other chronic and
and effectiveness, experts caution.
serious diseases. The FDA called on clinics to prove the safety
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In December 2018, the U.S. Centers for Disease
and efficacy of fat-derived stem cell treatments
Control and Prevention (CDC) reported 12 cases
through rigorous clinical trials. To make this
where patients suffered bacterial infections from
feasible for small businesses, the agency
2019 Integrative Healthcare Policy | A Year in Review
INTEGRATIVE PRACTITIONER TAKEAWAY For providers, the priority is the patient, but the obligation is to do no harm. Stem cell therapy sounds promising, but the research isn’t there yet to make sure therapies deliver on that promise. It is at the hands of practitioners conducting ethical, thorough clinical trials to make sure these innovative treatments are safe and effective.
Integrative Healthcare Policy
Going Forward Our work as the leading online community for integrative practitioners is made possible through your comments, tips, and ideas. We invite our audience to submit to our next volume.
For more information, please e-mail editor Katherine Rushlau at: krushlau@divcom.com
INTEGRATIVE HEALTHCARE POLICY
A YEAR IN REVIEW
An Integrative Practitioner Publication
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