David Dolan, MBA
Susan Miller, MD
Centers for Medicare & Medicaid Services (CMS)
7500 Security Boulevard
Baltimore, MD 21244
July 30, 2019
Ref: Proposed Decision Memo for Acupuncture for Chronic Low Back Pain (CAG-00452N)
Dear Dr. Miller and Mr. Dolan:
On behalf of the American Association of Chinese Medicine and Acupuncture, we have some suggestions for CMS on the proposed analysis. AACMA is founded in California 36 years ago and one of the largest professional groups of Chinese medicine and acupuncture in the United States. We strongly support CMS to carry out the clinical trial of acupuncture for chronic low back pain (cLBP). Acupuncture originated from China and has a history of more than 3,000 years, yet in recent decades it has increasingly been popular around the world and recognized by the mainstream conventional medicine in the United States. With its good efficacy shown by many studies, safeness with minimum side effects, and high cost-effectiveness, acupuncture is the obviously advantageous treatment for cLBP and a variety of diseases. We believe that integrating acupuncture therapy into the Medicare insurance system would provide patients with an easier access to the opportunity to have an effective and safe alternative or complementary therapy to reduce pain, restore functions, minimize reliance on opioids, and even more could cut down the overall expense of our medical system. Therefore, it is in the best interests of Medicare beneficiaries and also our medical system to include acupuncture treatment in Medicare insurance.
The following are our recommendations for the proposed memo:
1. According to the 2012 Andrew Vickers meta-analysis [1], acupuncture treatment of chronic back pain and other pains was found to be superior to both no acupuncture control and sham acupuncture group. However, the sham acupuncture is considered to be undermining the true acupuncture’s therapeutic effect. Given the inherent flaws by the design of sham acupuncture and the nature of acupuncture treatment itself, please consider adopting pragmatic research design to better study and recognize the effectiveness of acupuncture therapy.
2. The Decision Summary B states, “Physician assistants, nurse practitioners/clinical nurse specialists (as identified in 1861(aa)(5)), and auxiliary personnel may furnish acupuncture if they meet all applicable state requirements and have:
• A masters or doctoral level degree in acupuncture or Oriental Medicine from a school accredited by the Accreditation Commission on Acupuncture and Oriental Medicine (ACAOM);
• a current certification by the National Certification Commission for Acupuncture and Oriental Medicine (NCCAOM); and
• maintained licensure in a U.S. state or territory to practice acupuncture.”
The above requirements do not meet the reality of acupuncture profession. Different state has different acupuncture laws. To practice acupuncture in California, California laws require passing the California Acupuncture Licensing Exam (the board exam) which is totally different and independent from the NCCAOM Exams. Holding a NCCAOM certificate doesn’t meet the California laws. About the degree requirement from an ACAOM accredited school, an applicant who has completed education and training outside the U.S. is allowed to take the board exam and eventually acquire license to practice if the applicant meets the educational standards established pursuant to the California laws. California licensed acupuncturists (L.Ac.) account for nearly 40% of the nation’s total. If this proposal is passed with the above requirements, most of the California L.Ac.s will not be allowed to participate in the project. That will be regrettable to the project and unfair to many competent California L.Ac.s. Therefore, it’s more realistic to keep only the last requirement, “maintained licensure in a U.S. state or territory to practice acupuncture.” Furthermore to make sure the participant L.Ac. is better qualified for the proposed analysis, the L.Ac. is recommended to have at least five years of clinical experience.
3. The Decision Summary B states, “Auxiliary personnel furnishing acupuncture must be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist.”
Currently the entry level for a L.Ac. is master degree, and many of them have already acquired PhD degree. Many states’ laws describe L.Ac. as an independent health care provider. It’s natural to consider them as the more educated and seasoned experts in their own profession relative to professionals from other fields. I’m wondering how PA, NP, or nurse would supervise L.Ac. in acupuncture aspect. This requirement should be modified in a way to reflect the appropriate collaboration relationship among the personnel.
4. It’s best to invite some senior L.Ac.s in the design, operation, and evaluation of this clinical trial. The participation of senior L.Ac.s will reduce errors and have greater credibility in the design, operation and evaluation of this clinical trial.
5. AACMA strongly recommends the senior acupuncture experts in the United States, Lixing Lao [2], Jun Mao [3], and Yongming Li [4], to participate in the design and review of this CMS clinical trial.
6. AACMA here provides the “Clinical Guide for Chronic Low Back Pain” [5] developed by experts from the World Federation of Acupuncture-Moxibustion Societies two years ago. It is recommended that CMS announce it in its networks and use it as a reference in the design and review of this clinical trial.
7. It is recommended that CMS establish a big data platform [6,7,8], and then collect, analyze and compare the clinical data of acupuncture treatment of cLBP in the United States and even around the world, and conduct this clinical trial from a larger scope to reflect the true effectiveness of acupuncture on cLBP.
We expect CMS’s acupuncture clinical trial for cLBP to go smoothly and successfully. AACMA will be glad to provide assistance and contribute to the completion of the project.
Sincerely,
The Board of the American Association of Chinese Medicine and Acupuncture
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3658605
[2] https://scm.hku.hk/Views/People/English-ProfessoriateStaff.html
[3] https://www.mskcc.org/cancer-care/doctors/jun-mao#
[4] https://www.herbacupuncture.com/
[5] https://www.sciencedirect.com/science/article/pii/S1003525717300168
[6]https://www.congress.gov/bill/114th-congress/house-bill/34
[7]https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
[8]https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-electronic-health-record-data-clinical-investigations-guidance-industry
[9]https://www.medicalacupuncture.org/Portals/2/PDFs/Coding%20Fact%20Sheet%20Final%20Version.pdf