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Exclusive Interview with Dr. Paul Anderson: The FDA and the Fate of Compounded Medicines

The following is an excerpt of interview with Paul Anderson, ND on the FDA’s recent stance on compounded medicine as published in the Journal of Restorative Medicine, Volume 8, Number 1, 4 January 2019, pp. 1-5(5). Excerpt provide by Today’s Practitioner.

The Journal of Restorative Medicine (JRM) recently interviewed Paul Anderson, ND, who is testifying atU.S. Food and Drug Administration (FDA) hearings in support of maintaining the availability of several hundred compounded medicines. The FDA is considering enacting legislation that would make it illegal to compound or possess these commonly prescribed natural substances. If enacted, this legislation would affect clinicians as well as compounding pharmacies. JRM believes it is crucial for integrative medicine practitioners to have information about this process.

JRM: You’ve been attending hearings at the FDA, where the fate of a large number of natural medicines is under review. Please give us an overview of what’s going on and how you came to be present at these hearings.

Dr. Anderson: A number of years ago, the FDA asked compounding pharmacies, natural medicine practitioners, and integrative medicine practitioners to nominate substances for a hearing process. I believe the people who nominated substances took the FDA at its word, namely that all substances would get a fair hearing. However, the FDA’s motivation was that if any of these substances did not have what is known as a USP-NF federal monograph (a combination of two compendia: the United States Pharmacopeia and the National Formulary), regardless of whether the substance was a regular drug, an off-label drug, or a natural substance, it would become illegal to compound. These hearings are referred to as the “bulk drug substances for pharmacy compounding” under Section 503A of the Federal Food, Drug, and Cosmetic Act. Around 310 substances were nominated for review. The FDA said it would look at each of these substances individually. I’ve attended the hearings as a subject matter expert. Subject matter experts write testimony that gets included when a substance is nominated for review, as well as attending in person to testify on behalf of that substance.

JRM: So, what is happening to the fate of these 310 substances?

Dr. Anderson: Contrary to what we expected, the FDA went through the list of 310 substances and said that only a certain number of them even warranted a hearing. As a result, the list was cut down from 310 to about 68 substances that were deemed worthy of a hearing. The remaining approximately 242 substances, most of which happen to be natural medicines, got assigned to category 3, comprising bulk drug substances nominated without adequate support. This means that if the FDA process is enacted as a federal rule, these substances will automatically become illegal to compound, without even having had a hearing.

JRM: What are examples of some of the substances listed under category 3 that would become illegal to compound?

Dr. Anderson: Lactobacillus acidophilus, alfalfa, anise seed, certain types of copper, certain types of magnesium, a lot of minerals, a number of herbal substances that might be used in a compounded sense, and a whole host of things nominated by pharmacists that aren’t used as medicine but are used as binders or excipients (such as powdered milk) and would become illegal according to this list for a pharmacy to use. In reality, what it comes down to is everything will automatically be illegal to compound, except whatever tiny fraction of substances of the already small group deemed worthy of hearings that make it to the FDA “yes” list!

JRM: What has happened to the remaining 68 or so substances that were deemed worthy of a hearing?

Dr. Anderson: Those substances were put on the category 1 list. As of this time, hearings have taken place for 53 of them. Thirty have been deemed unsafe for compounding; 16 have been approved as safe; and about 18 are still awaiting hearings. Examples of things on the category 1 list that did get FDA hearings and which the FDA says should be illegal to compound include many substances that are inside our bodies, such as acetyl carnitine, certain forms of glutamine, chondroitin, D-ribose, and a number of other things that we actually can’t live without. The list also includes commonly used natural substances such as artemisinin, Boswellia, MSM (methylsulfonylmethane), glycyrrhizin, and certain B vitamins such as nicotinamide. The way the FDA hearings are set up, if these substances do not have some very clear medical indication for which they are the only treatments, the FDA essentially tells the committee that they should not approve it.

Click on the link below to read the full interview and more on how the FDA’s stance places integrative providers in a difficult situation and what you can do to support Dr. Anderson and others. 

Click Here for the Full Interview

Paul Anderson, ND, is a graduate of the National University of Natural Medicine and a full professor at Bastyr University. He is cofounder of Advanced Applications in Medical Practice and is a well-known continuing education presenter specializing in complex clinical medicine, intravenous and injection medicine, oncology, and genomics. Dr. Anderson has participated in National Institutes of Health – funded research in integrative oncology and is coauthor of Outside the Box Cancer Therapies: Alternative Therapies That Treat and Prevent Cancer. He has also authored or coauthored numerous peer-reviewed and educational publications in science and health.

Legislators and Staffers Get a Hands-On Introduction to Integrative Medicine
By Kimberly Lord Stewart

WASHINGTON DC – On March 6, 2019, the second annual Congressional Integrative Health and Wellness Caucus, co-led by Rep. Judy Chu (D-CA), and Rep. Jackie Walorski (R-IN), was held for an audience of 50 Democratic and Republican House offices, representing 24 states, and eight Senate offices, including the Democratic Leader, Democratic Whip, Assistant Democratic Leader, Senate HELP Committee, and Senate Committee on Homeland Security and Government Affairs.

“The Congressional Briefing and interdisciplinary therapy demonstration were extremely successful with representation form 58 legislative offices from both sides of the aisle. The briefing provided important information regarding effective, non-opioid, integrative approaches to the treatment of pain which will hopefully impact future policy,” said Len Wisneski, IHPC Board of Director’s Chair.

“The response was amazing,” said Kallie Guimond, IHPC’s Director of Government Affairs. “These people are the very same who are going to write legislation for non-pharma options to pain management. Eight Senatorial offices crossed the street to find out more.”

Above all, this year’s caucus itinerary gave participants a true reflection of the heart and soul of integrative medicine. That humanistic touch started with the opening chairs remarks. “The two Co-chairs of the Congressional Caucus broke away from their critical Ways and Means Committee meetings to open the briefing, sharing touching personal stories about why they are committed to advancing non-pharmacological approaches to pain and doing so now,” said Margaret Chesney, PhD, IHPC’s Special Advisor, Professor of Medicine School of Medicine, University of California, San Francisco.

In her remarks, Rep. Walorski shared the following, “I have heard from physicians and providers in my district who are eager to see the nonopioid methods of treating become more integral in patient’s conversations.” She closed by reiterating the horrific story of a death in South Bend, Indiana of a dear friend, Dr. Todd Graham, a local physician who believed in finding creative and alternative ways to address pain. A little more than a year ago, he was shot in his practice driveway from an opioid addict after trying to falsify records to get opioids. Graham’s refusal led to his death. Rep. Walorki said this tragedy is the motivation behind her work to expand the scope of integrative care for chronic pain.

In her opening statement, Rep. Chu held nothing back as she praised the skills of experts in the room and how their respective professions can make a significant difference in the opioid crisis. “The opioid epidemic is taking over lives in every state every day. Right now, deaths from overdoses exceeds those of all other deaths for people under 50,” said Rep. Judy Chu in her opening statement. “The good news is that studies conducted by NIH have concluded that alternative treatments can be effective in treating conditions like chronic pain.” Rep. Chu shared how she has been a long-time advocate of acupuncture. In 2001, when she was elected to the state legislature, Chu worked to get approval for acupuncture to be included in the workman’s compensation system. “I understand well, how important these alternative therapies are. But here in Congress, our biggest challenge is convincing our fellow members that not only do these integrative therapies work, but they should be available to all patients no matter how they get their health coverage,” she said. Click here for video of opening remarks.

The caucus made great headway this year to get that message across. There were multiple opportunities for legislators and staff to learn about integrative medicine. Integrative health experts from academic, government, and association settings held an educational briefing, a lunch featuring anti-inflammatory foods, as well as demonstrations on complementary therapies whereby attendees experienced the benefits of integrative medicine for pain and stress management.

Speakers included members of the military who shared moving and captivating testimonials of how integrative care made a dramatic impact on their health, said Guimond. Other speakers included:

• Margaret Chesney, PhD, on an integration to integrative health;
• Bob Twillman, PhD, on comprehensive integrative pain management;
• Casey Seenauth, ND, on non-pharmacological multi-modality approach to pain;
• Susan Luria, MD, MPH, on models of care in the Veterans Administration;
• Jill Sheppard Davenport, MS, MPP, CNS, NBC-HWC, LDN, LN, on nutrition’s role in pain management.

The integrative therapy room was remarkably successful thanks to teams of therapists and practitioners in acupuncture, chiropractic, massage therapy, and naturopathy, as well as certified reflexologists and craniosacral practitioners. “In a matter of minutes, a meeting room in the Rayburn Building was transformed into a healing environment, said Chesney. “This is a first. We’ve never had so many therapies and disciplines in one room on Capitol Hill. Ninety offices took time out of their day to stop in for 20 minutes for a therapy session. Many came back twice,” said Guimond.

Capitol Hill is known for being a pressure tank. This was not lost on the therapists who immediately saw a difference after a 20-minute treatment. “The feedback that I got from staffers and legislators was how fried they were and how much better they felt with the treatment,” said Amy Mager, vice chair of the American Society of Acupuncturists. “A staffer came in and said she was so grateful we were there because she didn’t have time to get to her acupuncturist. It was a privilege to be of service and watch staffers and legislators slow down. I watched them hold their bodies with more ease during and after the treatment. Providing value and the opportunity for people to reframe what’s going on in their body and come to a place of ease is a privilege.”

A common observation among the therapists was the level of genuine interest by those who came in for a therapy session. “What I found surprising, was that each person I worked with had quite a few questions about reflexology,” said Tish Gilmore, owner of Reflexology by Tish. “I thought people were just being polite, but I was given thoughtful, in depth and inquisitive questions. It was an honor to be there, answering questions and showing them how reflexology works. Within just a few minutes of working on their feet, the participants were truly beginning to relax; shoulders began to drop, breathing became slower and deeper, faces softened.  Believe me, the people I worked with were sorely in need of some relaxation!”

At the end of a very productive day, all agreed that the caucus was a great success. “Many asked if we could do this once a month,” said Guimond. “Monthly is ambitious, but it showed that if we are to move the needle forward on interdisciplinary care, examples of integrative medicine need to be hands-on.” The experts, patients and practitioners set a shining example of the potential for integrative care. Now that message needs to translate to legislative change.

In the coming months, IHPC will post each of the speaker’s videos so that you hear from the speakers and can gain a better understanding of this very important day for integrative care.

The Congressional Integrative Health and Wellness Caucus and IHPC would like to thank our title sponsor Life University. Without their support, and the support of those listed below, this event would not have been possible:

• Academy of Integrative Health & Medicine
• American Academy of Medical Acupuncture
• Bastyr University
• International Chiropractic Association
• Palmer College of Chiropractic
• Boiron Homeopathy
• +CBD Oil/CV Sciences 

Rep. Judy Chu, D-CA., and Rep. Jackie Walorski , R-IN led the Congressional Integrative Health & Wellness Caucus in the 116th Congress. The Caucus serves as a non-partisan educational forum for legislators to receive up-to-date information from experts related to best practices and new research, and to discuss legislative and administrative opportunities for integrative health.

ABOUT IHPC /The Integrative Health Policy Consortium is the national policy and advocacy voice of integrative health and wellness healthcare professional organizations, representing the voice of more than 600,000 healthcare providers. IHPC functions as a critical watchdog and monitor of federal agencies charged with overseeing America’s health and health research needs, working towards eliminating barriers to health. IHPC Chair Dr. Len Wisneski is a Clinical Professor of Medicine at George Washington University Medical Center, Adjunct Faculty at Georgetown University, and is on faculty at The University of Colorado. He has published over 30 scientific articles and a landmark textbook, “The Scientific Basis of Integrative Health.” Website: http://www.ihpc.org.

Bipartisan Effort Cites Prevention and Healthcare Delivery Change

The bipartisan Congressional Integrative Health and Wellness Caucus has been registered with two new co-chairs at the helm for the 116 th Congress. Representative Judy Chu (CA-21 st ) will serve as the Democratic leader with Representative Jackie Walorski (IN-2 nd ) as the Republican leader, replacing former Caucus co-chairs Colorado Congressmen Polis and Coffman, respectively.

The Caucus will hold its first meeting of the new Congress on Wednesday, March 6, 2019 on Capitol Hill with an education program and active demonstrations of integrative treatments provided to House Members and staff.  Given the recent passage of the HR6 SUPPORT Act addressing the country’s opioid crisis, the focus of the event will be integrative models of care for pain management. Both Representatives sit on the powerful Committee for Ways and Means, which ultimately governs Medicare, along with payments to health care providers delivering care to Medicare beneficiaries, such as those working in hospitals, surgery centers and outpatient departments.

Both new Caucus co-chairs were instrumental in crafting language for the HR6 SUPPORT Act and are involved in seeking legislative solutions regarding patient access to nonpharmacologic treatments and services for pain and addiction.

Congresswoman Chu stated, “The opioid epidemic in our country has made it more important than ever to explore non-opioid alternatives to pain management. That is why I am so pleased to be a cofounder of the Integrative Health and Wellness Caucus. Through this caucus, we hope to educate our colleagues about safe alternatives like acupuncture, which for millennia has been successful at treating a number of health conditions in addition to pain. I am hoping we can help make more healthcare options available and accessible to all Americans.”

“Integrative health care approaches are critical to treating pain, one of the biggest health challenges Americans face,” said Congresswoman Walorski. “As co-chair of the bipartisan Integrative Health and Wellness Caucus, I look forward to working with my colleagues to combat the opioid crisis and help patients by improving access to innovative and multidisciplinary approaches to pain management. I am committed to working across the aisle to ensure patients and providers have access to non-opioid alternatives and the comprehensive care they need.”

The event sponsored by the bipartisan Representatives is open to all members of Congress and their staff. Hosted by the Integrative Health Policy Consortium, speakers will educate lawmakers on what integrative health models of care look like, what current barriers to access for these care models are, as well as hold demonstrations of services designed to treat chronic neck and back pain with nonpharmacologic methods.

IHPC Director of Government Affairs, Kallie Guimond, stated “IHPC applauds the efforts of the Integrative Health and Wellness Caucus co-chairs in addressing the current opioid crisis and looking for innovative ways to deliver healthcare services and treatment options that include nonpharmacologic options for the millions of Americans that struggle with pain and addiction. We look forward to working with the co-chairs to build Caucus membership and to be a resource for its members for many years to come.”

Members of Congress who would like to join the Caucus should contact Representative Chu’s office directly at 202-225-5464. For more information on the IHW Caucus, contact IHPC’s Director of Government Affairs, Kallie Guimond, at kguimond@ihpc.org or visit IHPC Info For Congress.

See Full Report Here

As we enter the latest week of the Federal Government shutdown, there is still a flurry of activity in the states that impact Integrative Health organizations, practitioners and patients. IHPC is currently tracking 84 bills nationwide with most of the state legislatures looking to resolve the opioid crisis by expanding access to complementary treatment services and fill gaps in healthcare delivery regarding pain management.

Read Our Full Report Here

Want your voice heard about integrative pain management? The Pain Management Best Practices Interagency Task Force issued its draft report in late Dec. 2018. The comment period is open for the next 90 days. Read more here.

While Congress spent much of 2018 locked in a stalemate, a key integrative health and wellness legislative effort gained traction and was moved to enactment, which created a significant opportunity for 2019. HR6, the SUPPORT Patients and Communities Act (PL 115-271), touted by mainstream media as “the opioid package,” was signed into law on October 28, 2018 and set up the integrative health community as stakeholders in a series of government studies.

The anticipated outcomes will shape new integrative models of care for people who suffer from pain and addiction to include a variety of treatment options and therefore, reduce both the amounts of opioids being prescribed and the number of people suffering from substance-use disorders.

HR6 was an unusually bipartisan effort on the part of the 115^th Congress, answering the call of an immediate crisis that has brought what seems to be a rare example of cooperation between Republican and Democratic constituencies. Upcoming studies will identify barriers of access to nonpharmacologic treatment options and define appropriations for demonstration programs to state acute care and emergency room settings. These actions will determine effective models of care for pain management that are medically-assisted, nonpharmacologic and incorporate multiple modalities.

Many members of the Congressional Integrative Health and Wellness Caucus (IWHC) contributed directly to language that was enacted in HR6. IHPC will continue to help build out this Caucus as the 116^th Congress begins their duties following the Democrats taking the House gavel on January 3, 2019. Priorities for the upcoming members of Congress will continue in this arena, with an effort to provide appropriations for coverage and reimbursement for integrative treatment options not currently covered.

The legislative environment in the states also mimicked this trend of efforts to combat the opioid crisis with numerous states passing legislation that would either provide coverage for integrative treatment options or fund pilot programs to study the issues. As the 2019 legislative season unfolds, the states will begin to apply for available funding to participate in the initial fifteen state demonstration programs to share data regarding models of care.

IHPC and their Partners for Health played instrumental roles in building out the new IHW Caucus, helping shape language surrounding pain management, expansion of providers who can prescribe medically assisted treatments and the study and implementation of nonpharmacologic treatment options. These efforts will continue and grow through state and federal initiatives as we move forward in 2019.

The Integrative Health Policy Consortium (IHPC) is a unique interprofessional federation of organizations focused on health creation—the proactive promotion of and focus on prevention, wellness, and well- being. As the policy and advocacy voice of integrative health and wellness professionals, IHPC has achieved groundbreaking success toward the transformation of health and healthcare delivery, even as the prevailing paradigm of healthcare remains entrenched in a disease-based philosophy.

IHPC–a 501(c)(4) non-profit organization—advocates 1) for better access by individuals to their choice of licensed or certified providers within a pluralistic healthcare system, 2) for non-discrimination in payer coverage of all licensed providers within their scope of practice, and 3) for collaborative efforts among healthcare providers and other stakeholders to take a whole-person healthcare-delivery approach to the individual, which includes consideration of the social, cultural, economic, and environmental determinants of health.

The Integrative Health Policy Consortium (IHPC) again partnered for the 2^nd invitation-only Integrative Pain Care Policy Congress, in Boston, on Saturday, November 10, 2018. Sixteen IHPC Partner for Health (PFH) members attended. The Congress was facilitated by the Academy of Integrative Pain Management in partnership with IHPC and Pain Action Alliance to Implement a National Strategy (PAINS).

The Integrative Pain Care Policy Congress event brought together as many as 100 leaders and 65 organizations (see the complete list here), who have expertise and are dedicated to advancing integrative pain management. The organizations represented the licensed and certified health care professionals, public and private payers, people with pain, members from the Executive Branch, purchasers of healthcare, researchers, policymakers, and policy experts.

“Patients and clinicians and public health policy makers are really being forced to confront the reality that we have a number of Americans who suffer from chronic pain,” said Clayton Jackson, MD, president, Academy of Integrative Pain Management (AIPM), and clinical assistant professor of family medicine and psychiatry, University of Tennessee College of Medicine, Memphis, said in a statement to Medscape Medical News. “Those patients have inadequate access to proper resources for pain management. We can’t just throw opioids at the problem; we have to acknowledge that many patients require multimodal treatment to achieve best symptomatic reduction and functional improvement,” he added.

On the heels of recent passage and signing into law of HR6, the Support Act, this Congress is all the more important to helping solve the opioid crisis. “Comprehensive, integrative pain management (CIPM) will improve the lives of millions of Americans, save billions of dollars, and reduce opioid prescribing,” says Len Wisneski, MD, Board Chair of IHPC. “The only way this crisis will ever be resolved is if stakeholders come together to advocate and identify federal and state action. The Integrative Pain Care Policy Congress is providing a platform for that consensus development of policy change,” he said.

In 2017, participants of the inaugural Policy Congress developed a consensus definition of comprehensive, integrative pain care. Since then, three working groups mobilized to advance this definition of care through timely and relevant action. The Workgroups include: Coverage and Constraints; Promoting Comprehensive, Integrative Pain Care; and Strategic Communication—with participants comprising the breadth of stakeholder views mentioned above.

The agenda this year included interactive presentations and discussions in the morning and over lunch from invited policymakers, regulators, payers, people with pain, and members of the Executive Branch agencies. During the break-out sessions IHPC members joined other integrative pain care experts to discuss key issues affecting the advancement of a CIPM system. They included Executive Branch programs and activities, state and federal policy and advocacy activities, provider reimbursement and best practices of care for pain and how to transition toward these best practices.

There is no shortage of work to be done to advance comprehensive integrative pain care. However, despite the somewhat daunting task, there are a number of opportunities for best practices within the integrative community to be transformed into scalable policies. The participants identified a number of next steps that are critical to accomplishing these goals and lowering the barriers to care. Jackson says that by the end of the year, white papers are expected to be published, which will provide a blueprint and clear framework for policy makers.

At present, it is very difficult for patients to access and afford the treatments that are the most beneficial. “This is the whole reason for the congress’s existence — so we can use the power of multiple patient advocacy organizations, professional societies, and others to say this is what we need,” said Jackson in a MedScape statement. “Everybody is under the same tent; everybody is working together and pulling in the same direction for what’s best for patients,” he said.

The Integrative Health Policy Consortium (IHPC) is a unique interprofessional federation of organizations focused on health creation—the proactive promotion of and focus on prevention, wellness, and well- being. As the policy and advocacy voice of integrative health and wellness professionals, IHPC has achieved groundbreaking success toward the transformation of health and healthcare delivery, even as the prevailing paradigm of healthcare remains entrenched in a disease-based philosophy.

IHPC–a 501(c)(4) non-profit organization—advocates 1) for better access by individuals to their choice of licensed or certified providers within a pluralistic healthcare system, 2) for non-discrimination in payer coverage of all licensed providers within their scope of practice, and 3) for collaborative efforts among healthcare providers and other stakeholders to take a whole-person healthcare-delivery approach to the individual, which includes consideration of the social, cultural, economic, and environmental determinants of health.

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This survey, Life in Rural America, conducted for National Public Radio, the Robert Wood Johnson Foundation, and the Harvard T.H. Chan School of Public Health, shows that rural Americans identify drug addiction or abuse (including opioids) and economic concerns as the two biggest problems facing their local communities. This summary infographic of the report paints an alarming picture of the problem. To access full report, click here.

On Wednesday, October 24, 2018, the President signed into law: H.R. 6, the “Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the “SUPPORT for Patients and Communities Act,” which addresses the opioid crisis by reducing access to and the supply of opioids and by expanding access to prevention, treatment, and recovery services. Passage was overwhelmingly bipartisan (98-1 in the Senate and 396-14 in the House).

“While much remains to be done, the Integrative Health Policy Consortium (IHPC) is encouraged by this first legislative step to give patients better access to integrative therapies for pain treatment,” says Leonard Wisneski, MD, FACP, Chair of the IHPC Board of Directors.

The bill contains more than 200 provisions designed to improve opioid prevention and treatment efforts. The IHPC believes the H.R.6 Act provides opportunities for the integrative healthcare community to align themselves around a single mission for patients to have better access to non-pharma, whole-person integrative care for pain management.

“Regardless of modality, the integrative community is ideally positioned to serve as experts in education, evidence-based approaches and treatments and as an important community resource regarding non-pharma solutions to pain management,” says Kallie Guimond, IHPC’s Director of Government Affairs. “There are a number of provisions in HR6 that IHPC will be pursuing as the opportunity to unite and educate physicians about the science and effectiveness of integrative approaches and solutions for pain,” she says.

Among the hundreds of provisions, Guimond identified a number of opportunities:

1. By January 1, 2019, The Secretary of Health and Human Resources (acting through the Administrator of the CMS), “will present one or more financial documents (new or updated) to states for mandatory and optional items and services for non-opioid treatment and management of pain, including evidence-based, non-opioid pharmacological therapies and non-pharmacological therapies.”

2. The Social Security Act (42 U.S.C. 1395b-2) has been amended to include: 1) “references to education resources regarding opioid use and pain management;” 2) “descriptions of categories of alternative, non-opioid pain management treatments covered under this title;” and, 3) “a suggestion for the beneficiary to talk to a physician regarding opioid use and pain management.”

3. As part of the Opioid Addiction Action Plan, within 3 months of enactment, there will be a request for public feedback regarding ways for the CMS to help address the opioid crisis.

4. Within one year of enactment, a study will be conducted to analyze best practices and coverage for pain management. The study will include evidence-based treatments and technologies for acute pain, including treatments that are covered, not covered or have limited coverage under the title XVII of the Social Security Act. Evaluation of treatments, such as acupuncture, therapeutic massage and services provides by integrative pain management programs are included in the provision, as is the VA/DOD Clinical Practice Guideline for Opioid Therapy for Chronic Pain.

5. Lastly, a variety of financially substantial grant programs will be available to develop strategies and train providers and personnel on protocols and best practices that target treatment alternatives to opioids in hospital and emergency room settings. This will include demonstration programs for experts with robust knowledge that have successfully implemented programs that use alternatives to opioids. Acceptable programs, including those from the National Center for Complimentary and Integrative Health or other centers within the National Institutes of Health will be included.

IHCP’s Partner For Health member organizations will continue to advance alignment with key stakeholders in pain management to provide resources and tools for integrative health resources for education and treatment protocols for non-pharmacological and non-opioid pain solutions. Following their partnership with IHPC member the Academy of Integrative Pain Management for the upcoming 2nd Integrative Pain Policy Congress, IHPC will address a campaign strategy to integrate the provisions of H.R.6 within the organization’s policy goals and partnership with Congressional House members through the recently formed Integrative Health and Wellness Caucus.

To assist in expanding collaboration, regardless of modality, IHPC has formed a new National Alliance for Integrative Health Policy Advocacy. “Our voices and expertise can make a dramatic difference to give patients more opportunities for effective, evidence-based integrative pain treatments,” says Dr. Wisneski.

If you haven’t already done so, please support IHPC (more information here) and take a look at the Moving Beyond Medications guidelines for pain management and treatments.

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The Integrative Health Policy Consortium (IHPC) is a unique interprofessional federation of organizations focused on health creation—the proactive promotion of and focus on prevention, wellness, and well- being. As the policy and advocacy voice of integrative health and wellness professionals, IHPC has achieved groundbreaking success toward the transformation of health and healthcare delivery, even as the prevailing paradigm of healthcare remains entrenched in a disease-based philosophy.

IHPC–a 501(c)(4) non-profit organization—advocates 1) for better access by individuals to their choice of licensed or certified providers within a pluralistic healthcare system, 2) for non-discrimination in payer coverage of all licensed providers within their scope of practice, and 3) for collaborative efforts among healthcare providers and other stakeholders to take a whole-person healthcare-delivery approach to the individual, which includes consideration of the social, cultural, economic, and environmental determinants of health. For more information go to IHPC.org or call, 202.505-IHPC (4472)

Having an undergrad in Aerospace Engineering was probably not the best preparation for acupuncture training.  I was taught there were universal “laws” that could be communicated through equations (F=MA, E=Mc²…), and the cosmos operates predictably within those parameters.  And then I was introduced to the concept of “Qi” (pronounced “chee”) that can’t exactly be measured, quantified, or mathematically modeled.  Some call it universal energy, scientists refer to it as biophotonics, others describe it as life force, and they’re all correct.  The Chinese actually have myriad types of Qi supporting the conceptual framework of Traditional Chinese Medicine (TCM).  There’s Gu Qi (aka “grain Qi”) which is the energy contained in food.  (A modern view would be fats, carbohydrates, protein, etc.)  Yuan Qi (“original Qi”) – is the energy you receive from your parents; today we refer to it as DNA.  Jing Qi (or “essence Qi”) is the actual genetic material that’s believed to be stored in the Kidneys.  Wei Qi (or “Defensive Qi”) is visualized as an energetic protective layer on the surface of our bodies, in our muscles and skin – today we would call that our immune system.  There are several others, but you get the point.

In TCM, Qi is considered the commander of Blood, and Blood follows the Qi.  If you have a contusion from an impact injury, a TCM practitioner would refer to that as “Blood stagnation” or Blood stasis.  The Qi fails to move the Blood, thus Qi is “blocked” by the Blood, leading to pain.  There’s a classic Chinese saying:  “If there is free flow, there is no pain; If there is no free flow, there is pain.”  If you look at a hematoma, it’s blood that’s extravasated from broken blood vessels (and is no longer moving) and is painful to the touch.  Inserting filiform needles into precise acupoints will promote the free flow of Qi and Blood, and reduce pain.  There are very interesting scientific explanations for how this works, but they’re beyond the scope of this article.

From a western medical point of view, pain is categorized as nociceptive (that due to some kind of noxious insult to the tissue) which is further broken down into somatic and visceral, neuropathic (nerve related due to a lesion or disease in the somatosensory nervous system), and inflammatory.  Similarly, TCM practitioners have various categories of pain that include:

1. Blood stasis/stagnation (fixed location, sharp/stabbing pain, impact injuries)
2. Qi stagnation (repetitive motion injuries, pain with emotional basis, paroxysmal pain)
3. Internal cold (types of arthritis that get worse with cold weather, menstrual cramps)
4. Heat or Fire (rheumatoid arthritis with redness and warmth, infection, burning eyes, sore throat, etc.)
5. Dampness (dull, aching pain, fatigue)
6. Wind Invasion (pain that moves around, like fibromyalgia)

To further complicate matters, you can mix and match some of the above conditions, such as having wind-damp.  Patients can have both internal wind conditions, and those related to external wind (like the common cold, that is further differentiated into “wind cold” and “wind heat”).  This also applies to heat and cold:  you can have both internal and external “invasion” of heat or cold as well as an “excess” or “deficient” condition.  A simple example is a bladder infection; the TCM diagnosis is “damp heat of the bladder,” which corresponds to the symptoms – burning during urination, fever, and fatigue.  There are acupuncture points that “clear heat,” “subdue wind,” or “resolve dampness,” that are applied to various pain conditions.

Acupuncture/electroacupuncture, herbal medicine and moxibustion (burning moxa or mugwort/artimesia vulgaris), cupping, tui na (Chinese therapeutic massage) and gua sha (special scraping technique) are all effective techniques for resolving acute and chronic pain.  Here’s an example to put all this together:

A 55 year-old white male complained of right side facial pain for three months, and was diagnosed with trigeminal neuralgia.  He had severe burning/cutting pain ten to twenty times per day. Physical examination showed a sallow complexion, red tongue with yellow coating, and string-taut, rapid pulse.  His TCM diagnosis was heat of the three yang meridians attacking the head and qi stagnation. Excessive stomach fire combined with a qi stagnation can lead to facial pain. The point prescription was S 44, located on the foot.  Oblique insertion (45 degree angle) to a depth of approximately .5 to .8 inches with rotating manipulation of the needle caused a cool sensation going upward along the lateral aspect of his abdomen, stomach and cheek.  The pain was relieved immediately.  After three treatments, he was greatly improved, and was cured after seven treatments.

Chen, Y., Deng, L.  Essentials of Contemporary Chinese Acupuncturists’ Clinical Experiences. Beijing, China: Foreign Languages Press; 1989

Did you know that Naturopathic Medicine Week, Oct. 7-13 and Acupuncture and Oriental Medicine Day (AOM Day), October 24^th are coming up soon? This is the perfect time to highlight your professions and bring attention to the fabulous work that you do. There are a number of ways to get involved and the Integrative Health Policy Consortium (IHPC) is helping get the word out to practitioners.

Naturopathic Medicine Week / In prior years, countless AANP members (practicing NDs as well as students) have organized events ranging from open houses, fun runs and lectures to wine tastings, film showings, health fairs and raffles. Here are a few ideas to spark your creative abilities:

1. Participate in the Whole Patient Whole Person Photo Contest. From October 7th – October 13th, submit your photo on Instagram (@institutefornaturalmedicine, hashtags #NatMedWeek2018, #WholePatientWholePerson) to share your whole patient, whole person experience, describing how naturopathic medicine takes care of the mind, body, and soul.
2. Shop for some Naturopathic Medicine Week gear or register for a special webinar offering on Resilience, Stress, and Epigenetics.

Get creative. Do your bit to promote the benefits of what you do professionally! You’ll be helping to gain patients, generate visibility, and ultimately improve our health care system. Click here for more information.

AOM Day / The website (www.aomday.org), sponsored by the Commission for Acupuncture and Oriental Medicine (NCCAOM), is an ideal resource to bring AOM awareness to your community. Whether you are an acupuncturist or not, IHPC encourages all of you to promote this unique day. Here are a few ideas to get started:

1. Link the AOM Day website (http://www.aomday.org/) and Facebook page to your website.
2. Inspire others and promote your events by registering your activities on the AOM Day website’s “Submit an Event” page.
3. Hold an Open House or a free clinic day in your community where you demonstrate acupuncture, Asian bodywork or Chinese herbal treatments free of charge or at a discounted rate.
4. Publicize your event for free on local radio stations and newspapers as a community event. There is even a handy toolkit from ASA and Acupuncture Media Works to promote your practice and acupuncture.
5. For more ideas go to the “Get Involved” page to take advantage of the various free marketing tools to advertise AOM Day as well as their practice.

In June, leaders in integrative care and advocacy met at the Integrative Medicine for the Underserved (IM4US) Conference on Capitol Hill. IHCP was honored to support the organizations first ever congressional briefing, Non-drug Solutions to Opioid Use and Chronic Pain Management in Underserved Populations.

IM4US fundamentally believes that healthcare is a right, not a privilege. The organization advocates to preserve those rights and promote the benefits of Integrative Medicine and the impact it can have on not only improving health outcomes for chronic diseases, but also in addressing the opioid epidemic.

The event, held at George Washington University (GW) School of Medicine and Health Sciences (SMHS) and the Milken Institute School of Public Health, attracted hundreds of experts in integrative care who shared practical ways of making people healthier, and discussed sustainable care models that make integrative health care more accessible.

“We are sincerely grateful for the GW School of Medicine and Health Sciences and Dr. Misha Kogan for hosting our annual conference,” IM4US President Priscilla Abercrombie, RN, NP, PHD. “It was incredible to see so many local practitioners and organizations who provide integrative services for the underserved participating in our conference either as presenters, attendees or volunteers. Our organization and movement is stronger when more voices like those from GW are engaged in the work we do.”

The conference attendees learned about affordable integrative approaches to common health conditions, shared evidence-based best integrative practices, and what does and doesn’t work when it comes to advocating for integrative medicine for the underserved.

“IM4US is a bright light that attracts holistic providers who cares for people unable to afford the cash prices required to receive care at most of Integrative Medicine clinics,” said IM4US Conference Co-Chair Mikhail “Misha” Kogan, MD, an assistant professor of medicine and associate director of the Integrative Geriatric Fellowship at the GW SMHS. “One would think that a deteriorating health care system, access disparities, poor federal and local funding for underserved communities would stop us from trying to do this work. Yet this conference proved that the light of passion in hearts of those trying to care for all is only getting stronger.”

Conference speaker, John Weeks, a writer, speaker, chronicler, and event organizer, was particularly struck by the leadership of IM4US in exploring the value of group visits and group-delivered services. For example, there were workshops and breakout sessions on various aspects of group visits, including how to build the facilitation skills needed to do them effectively. “The rest of medicine, and specifically those in the integrative health field, have a good deal to learn from the pioneering of people who presented,”

Next year’s event will be held in San Francisco. For more on the organization and the toolkit it designed for healing professionals interested in working in underserved settings, go to im4us.org.

Act Today! Your Voice Can Make the Difference.

The IAM4US congressional briefing on alternatives to opioids for chronic pain management is just one of the ways that IHCP is advancing awareness about integrative care, The only way to really make this happen, is for you to enlist your elected officials to join the Integrative Health and Wellness caucus. Constituent phone calls are effective in making change. Don’t hesitate!

Click here for more information to make your call.

Contact Your Representative to Join the Caucus

Interview with Tracy Gaudet, MD, Founding Director, VA Office of Patient-Centered Care and Cultural Transformation

Medical Acupuncture, Dr. Gaudet discusses with John Weeks, how she and her colleagues have worked to change the culture of the Veterans Administration. Her work is relevant to all practitioners who wish to change communication patterns and organizational “wellness” to improve the workplace interactions, physician burnout and patient outcomes.

Read More Here

Any service that is on track to consume 40 percent of the gross national product of the world’s largest economy by the year 2050 cannot be ignored and that service is US healthcare. The reason that IHPC encouraged House of Representative members Mike Coffman (R-CO) and Jared Polis (D-CO) to form the bipartisan Congressional Integrative Health and Wellness Caucus was explicitly to ensure that Integrative Health has an authoritative voice at the table with people making decisions about policy, legislation and regulations. Both Members Coffman and Polis also belong to the congressional Problem Solvers Caucus working to craft bipartisan healthcare solutions.

They know that when it comes to costly, chronic diseases, and crises like the opioid epidemic, integrative health approaches can offer improved outcomes with lower costs. In fact, a just released study today in JAMAshows there is no time to wait. The study revealed sad and striking numbers, “all deaths attributable to opioids increased 292% (from 0.4% to 1.5%) between 2001 and 2016, resulting in approximately 1.68 million person-years of life lost in 2016 alone.” Sadly, 20% of those deaths were adults age 24-35, a demographic that should be celebrating the future, not losing their lives to drug overdoses.

While there is high skepticism and often cynicism as to what Congress can accomplish in the current highly partisan and polarized environment, there are committed bi-partisan Members working to make a difference. What Congress does matters to more Americans than you might think! Congressional action has direct impact on the Centers for Medicare and Medicaid Services (CMS), the Marketplace, the Children’s Health Insurance Program (CHIP), the Federal Employees Health Benefits (FEHB) Program, the Veterans Administration and the Department of Defense health services. Millions of Americans are impacted by these services, and the private insurer and health services market usually follow their lead.

The Capitol Hill Caucus briefing on March 15, focused on integrative pain care and the opioid crisis, generated significant interest and requests for education and information from more than 30 Congressional offices (thank you to IHPC member AANP who included Caucus info in their Lobby Day). IHPC has continued to meet with legislators and their staff. On April 9, along with Board Member and AIPM Partner for Health Bob Twillman, PhD and interim Executive Director Susan Haeger, I met with both new Members and many interested in joining the Caucus. The whirlwind day across multiple buildings and offices confirmed high enthusiasm and interest in transforming healthcare to focus on prevention, wellness and well-being for health creation.

There is a sea change in the landscape for health and healthcare. Large systems of care are embracing integrative health and turning attention to how communities and states can promote health and wellness, as well as encourage more attention to disease prevention. In pain care and especially in the opioid crisis – non-pharmacological and integrative approaches are being sought out. The time is now for communicating with, connecting and catalyzing legislators to champion this shift so that Integrative Health and Wellness can take center stage in health and healthcare in America.

If you haven’t already done so, it’s time to enlist your elected officials to join the caucus. Constituent phone calls are most effective. Don’t hesitate! Click here for more information to make your call.

In Good Health,
Sincerely,

Leonard A. Wisneski, MD
Chair, Integrative Health Policy Consortium

Video Highlights from Caucus Briefing on Capitol Hill In March, the inaugural Health and Wellness Caucus took place in Washington DC. The bipartisan efforts of Reps. Jared Polis (D) and Mike Coffman (R) with the support of IHPC, were met with great success. We’ve collected the various presentations from the caucus speakers. Click on the image to the right to access all the videos. Click on the titles below to listen to the highlighted speakers:   1.  Introduction by Len Wisneski, MD, IHPC Board of Directors Chair 2.  Opening Remarks from Caucus Co-Chairs Reps. Jared Polis (D) and Mike Coffman (R) 3.  Ben Kligler, MD, MPH presents a segment on integrative practices within the Department of Veterans Affairs (VA).

CONTACT YOUR REPRESENTATIVES TO JOIN THE CAUSE

New Study: Active Integrative Protocols for Pain Management In this new study, researchers show that when patients are educated in integrative-care solutions, they are most likely to elect an active complementary pain management program. Study provided by our partners at Today’s Practitioner.   Read More Here

IHPC has responded to an RFI from the Centers for Medicare and Medicaid Services, CMS, on the issue of the future of the CMS Innovation Center, known as CMMI

CMMI was created by the Affordable Care Act to fund the development of new models of payment that would ultimately reduce the costs of healthcare in the U.S., at least that portion of it paid for care delivered through Medicare and Medicaid. The initial funding for this ambitious initiative was $10 billion. CMMI developed categories of clinical models through which it thought savings could be gained, through risk-sharing and other methods. In 2016 CMS presented the most important adjustment to its payment structure since Medicare was established, declaring that it would start to reimburse providers for value, rather than fee-for-performance.

The Innovation Center was created to assess, fund and underwrite payment models that serve its Medicare and Medicaid beneficiaries. Many score of models have been initiated since in recent years. But rarely have these models included integrative clinical centers or practitioners.

CMMI depends on stakeholders to come forward with applications for models, but because of the historic chasm between CMS and the integrative clinical community — despite its adoption by conventional systems in recent years — few integrative centers have made application to participate in its Alternative Payment Models (APM) program. This is due to the sustained uncertainty as to how even licensed practitioners who provide services that are “not usually paid for” (acupuncture, massage therapy, tai chi, yoga, etc.) can effectively participate to achieve CMS’ ambitious cost-saving programs. And that remains to be determined.

(Click the image of the letter for the PDF version.)

In its response to the CMS RFI, IHPC cited its mission: “Eliminating barriers to health” and noted:

The remaining and over-arching barrier that CMS can directly resolve is the inequitable status of reimbursement for services provided by state-licensed integrative providers, despite long-standing patient demand and robust clinical outcomes.

The letter, signed by IHPC Chairman Len Wisneski (at right), set out the summary of the cost-effectiveness research that IHPC compiled and published in 2015, “Integrative Health and Medicine: Today’s Answer to Affordable Healthcare”.

The letter also noted the important affirmation on the role that integrative non-pharmacologic pain treatment options have attained in the last several years, quoting from the President’s Commission on Combating Drug Addiction and the Opioid Crisis, released in November:

“The Commission recommends CMS review and modify rate-setting policies that discourage the use of non-opioid treatments for pain, such as certain bundled payments that make alternative treatment options cost prohibitive for hospitals and doctors, particularly those options for treating immediate post-surgical pain”

The letter also points out the important roles that integrative practitioners have assumed in primary care as the nation faces a primary care physician shortage; in group visits that Medicaid already funds; and in state innovation projects. It also requests that CMMI ensure that if necessary, integrative practitioners and clinical programs are granted waivers to ensure that payment for services is equitably distributed.

In its announcement of the RFI CMS said it may or may not respond to submitted recommendations.

Your voice and action can make a difference as our nation faces critical challenges in healthcare reform and management, including the national opioid crisis.

One of IHPC’s long-standing objectives has been to support simple and direct access for members of Congress to the most recent developments about the improved health outcomes and cost-reducing qualities of integrative practice and its increasing adoption within the U.S. healthcare system.

Bi-partisan partners — Democrat Judy Chu and Republican Jackie Walorski —have now taken leadership of the  Congressional Integrative Health and Wellness Caucus. Serving as a non-partisan educational forum for up-to-date information regarding the role of integrative health, wellness and medicine, the Caucus provides the opportunity for education and discussion regarding legislative and administrative options that can make integrative healthcare more readily available. Congress has significant authority over federally funded programs and grants to the states that impact health and healthcare in America.

Take Action as a constituent and urge your Representative to join this important bipartisan effort in Congress.

Click here to see all Caucus Videos

• The Campaign Moving Beyond Medications
• Press Release Supports 37 State AGs calling for Non-drug Treatment

Moving Beyond Medications

The crescendo that has been building over the last 24 months to bring non-pharmacologic pain treatment methods to the top of the therapeutic order has reached into the most important national U.S. medical organizations and standards bodies. While there is now strong acknowledgement of the importance of providing physicians and patients a full range of balanced pain management treatment options, making those choices is not yet as clear as it must be. To help that learning process, IHPC and its collaborative integrative partners have launched Moving Beyond Medications, whose principals are embodied in this succinct Pocket Guide.

The Academic Consortium of Integrative Medicine and Health (ACIMH), the Academic Collaborative for Integrative Health (ACIH), and the Academy of Integrative Health & Medicine (AIMH) joined forces with IHPC to address the critical need to inform and educate clinicians and the public on the importance of the balanced pain management treatments.

The Sept. 18, 2017 letter from the National Association of Attorneys General (NAAG) to the president of America’s Health Insurance Plans (AHIP) reinforced the calls from the American Medical Association, the College of Physicians and many other conventional medical organizations that non-pharmacological pain management treatments must be included in reimbursement plans.

In a press release supporting the NAAG letter, IHPC board chairman Leonard A. Wisneski, MD, FACP wrote: “This is a big step forward with the potential to save millions of lives and billions of dollars. Those in pain should not be denied proven and effective non-opioid options because of lack of coverage by insurers.”

Seasoned Advocacy Leader, Susan Haeger, Appointed Interim ED —

After four years leading significant growth of IHPC, Executive Director Alyssa Wostrel has stepped down to focus on new professional opportunities. Veteran policy and advocacy leader, and IHPC board member, Susan Haeger, has taken the reins as interim Executive Director of IHPC.

(more…)

In this short video, IHPC Executive Director Alyssa Wostrel speaks to the policy imperatives IHPC has pursued in support of Section 2706, the non-discrimination provisions of the ACA. (more…)

IHPC has submitted “Comments on proposed 2016 Guidelines for Prescribing Opioids for Chronic Pain” to the Centers for Disease Control and Prevention (CDC) strongly endorsing the evaluation of the Guidelines by the American Academy of Pain Management (AAPM, an IHPC Partner for Health).

Click the image above for the CDC page describing the guidelines

The letter (click here for a PDF of the letter) highlighted comments by AAPM’s Executive Director Bob Twillman, Ph.D., FAPM who noted the proven treatment value of acupuncture, chiropractic, naturopathic medicine and massage therapy as “chief among non-opioid treatments,” noting that “We need to find a way to increase patient access by ensuring adequate insurance reimbursements.”

AAPM has been a stalwart supporter of and partner with IHPC’s CoveMyCare campaign which seeks to end insurer discrimination against licensed integrative providers, as is called for in Section 2706 of the Affordable Care Act.

In its “Intended Purpose and Use of Guideline,” CDC presents on its web page:

“The purpose of the CDC guideline is to provide recommendations for the prescribing of opioid pain medication for patients 18 and older in primary care settings. Recommendations focus on the use of opioids in treating chronic pain (i.e., pain lasting longer than 3 months or past the time of normal tissue healing) outside end-of-life care.”

IHPC’s letter also notes the necessity of reversing the therapeutic order that too often has led to opioid prescribing before any other choice. “It’s clear that a balanced approach should be used in treating chronic pain, applying the least harmful and invasive techniques first in an integrative patient-centered setting.”

Citations used in the IHPC Letter to the CNC

• Integrative non-pharmacological approaches. Tick, H., Chauvin, S. W., Brown, M. and Haramati, A. (2015)
• American Academy of Pain Management (AAPM) Comments on proposed 2016 Guidelines for Prescribing Opioids for Chronic Pain
• ACCAHC Policy Brief – Never Only Opioids: The Imperative for Early Integration of Non-Pharmacologic Approaches and Practitioners in the Treatment of Patients with Pain
• Joint Commission Revisions to Pain Management Standard effective January 1, 2015
• Tick, H., et al. Core Competencies in Integrative Pain Care for Entry-Level Primary Care Physicians. Pain Medicine, 16: 2090–2097
• APHA Proposed Statement authored by Michele Maiers, DC, MPH
• Integrative Health and Medicine: Today’s Answer to Affordable Health Care: Health Creation Economics
• Tick, H., Integrative pain medicine: A holistic model of care. Pain Clin Updates, 2014
• World Health Organization Scoping Document for Treatment Guidelines on chronic non-malignant pain in adults. October 14, 2008

A new RAND report, Complementary and Alternative Medicine: Professions or Modalities? examines the state of CAM/integrative practice and the barriers they face to greater use and to reimbursement, and offers options for resolving some of them. (more…)

IHPC and AIHM encourage the new National Academy of Medicine to embed integrative practitioners into its important initiatives such as Healthy America, and Grand Challenges in Health and Medicine.

IHPC Chair
Len Wisneski, MD

AIHM President
Mimi Guarneri, MD

“Integrative Health and Medicine offers a comprehensive prevention-based approach
to effectively treat chronic disease and enhance health promotion, embracing a
multi-disciplinary team of licensed healthcare providers working at the highest level
of their scope of practice.”

 
 
The letter was written in response to a request from the new National Academy of Medicine (the former Institute of Medicine) for recommended topics for its series of “Perspectives” that are contributed by outside experts and organizations. You can see the current list of these contributions here.

Click the image for the full
joint IHPC-AIHM letter.

• Inter-professional Education and Collaboration, including the introduction to complementary and integrative health courses in medical school curricula
• Non-Discrimination in Healthcare (Affordable Care Act Section 2706) and working with state advocates and officials and federal agencies to enforce this law
• Improving research methodologies at the National Center for Complementary and Integrative Health (NCCIH) to ensure the best outcomes for investigations into complementary and integrative health topics
• The role that several integrative health disciplines play in primary care
• Traditional World Medicines
• Integrative pain management and the over-prescribing of narcotic and psychoactive drugs
• The transition to a patient-centered or “relationship based care” models

In August, IHPC’s Alyssa Wostrel introduced the real-world experience and benefits of integrative pain care to policy and legislative leaders of several of the nation’s primary pain advocacy organizations. (more…)

In addition to their important leadership experience in integrative health, Elizabeth Goldblatt and Martha Menard have contributed 20 years of volunteerism to ACCAHC. (more…)