Integrative Healthcare Policy Report - A Year in Review - Preview

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

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