ASA / NCCAOM Town Hall #2 Q&A

Question: What is the name of the herbal organization that was mentioned during the presentation?Answered on 4/10/20: American Herbal Products Association (AHPA);Michael McGuffin is the President of AHPABill Egloff is the Chair of AHPA’s Chinese Herbal Products CommitteeQuestion: What are the herbs that the FDA is cautious of, as mentioned by Michael McGuffin?Answered on 4/10/20: The FDA considers any botanical with pyrrolizidine alkaloids to beadulterated.Common Chinese herbs used are:- Kuan Dong Hua, Coltsfoot Flower, Tussilago farfara flos- Pei Lan, Eupatorium, Eupatorium Fortunei HerbaHerbs with aristolochic acid are also of concern. Aristolochic acid is a chemical constituent ofChinese herbs, such as Ma Dou Ling (Aristolochia debilis), Tian Xian Teng (Aristolochiacontorta), Qing Mu Xiang (Aristolochia cucurbitifolia), Guang Fang Ji (Aristolochia fangchi), GuanMu Tong (Aristolochia manshuriensis), and Xixin (Radix et Rhizoma Asari)Please note that Chuan Mu Tong, Caulis Clematidis Armandii, and Han Fang Ji, RadixStephaniae Tetrandrae, do not contain aristolochic acid.Question: What are the herbal formulas used as treatments in China?Answered on 4/10/20: Please review Lotus Institute’s How COVID-19 is Currently Treated inChina with TCM.Question: Bill Egloff mentioned studies done on TCM herbs. How can we get access to thisinformation?Answered on 4/10/20: Here are the links requested:- Herbal Safety information from Cleveland Clinic- Safety of Custom Traditional Chinese Herbal Medicine Practice at Cleveland ClinicQuestion: Is it illegal to grow ma huang and use it in your own preparations?Answered on 04/10/20: Ma huang, Ephedra sinica, seeds are available commercially, and donot contain ephedrine. The North American species of ephedra, Ephedra nevadensis, commonlyknown as “Mormon Tea” does not contain ephedrine.Question: Can we use ma huang in formula now? Can ma huang be used legally by practitioners?Answered on 4/10/20: Ma huang can be used by qualified health practitioners. However, it isillegal to import ma huang. For more information, see The US Food and Drug Administration’sFinal Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated BecauseThey Present an Unreasonable Risk; Final Rule, February 11, 2004Several Ephedra species (including those known as ma huang) have a long history of use intraditional Asian medicine. These products are beyond the scope of this rule because they arenot marketed as dietary supplements. The use of ephedrine alkaloids in traditional Asian04/07/2020 Town Hall MeetingPage 8

medicine is discussed in more detail in section V.B.5 of this document. As we describe there,this rule does not change how these products are regulated under the act. .V.B.5. Traditional Asian Medicine(Comment 44) Many comments stated that the use of ephedrine alkaloids in dietarysupplements is safe based on its traditional use in Asian medicine for thousands of years.Several comments asserted that few or no adverse effects have been recorded with the use ofEphedra in traditional Asian medicine. Numerous other comments, including those by traditionalAsian medicine practitioners, disagreed with these comments about dietary supplements,highlighting the differences in the products themselves and how they are used from whatis used in traditional medicine.Several comments suggested that the raw Ephedra and Ephedra extracts used in traditionalAsian medicine formulae differ in potency, toxicity, pharmacokinetics, and pharmacological andphysiological effects from many dietary supplements containing ephedrine alkaloids and,therefore, that these formulations should be considered distinct in scientific, medical, andregulatory contexts. Comments stated that Ephedra'' properly refers to dried aerial parts ofmedicinal plants, or crude extracts thereof, not to isolated alkaloidal constituents. Severalcomments further distinguished the various products containing Ephedra as follows: Herb andextracts of raw herb of medicinal Ephedra plants containing naturally occurring alkaloids andother compounds without further manipulation, concentration, or adulteration; Ephedraextracts that are concentrated, manipulated, or adulterated such that naturally occurringproportions and/or quantities of ephedrine alkaloids are altered; products containing ephedrinealkaloids combined with other agents such as caffeine, caffeine-containing herbs,salicylate-containing herbs, synephrine, and other substances; and traditional Asian herbalmedicinal formulae.Several comments asserted that traditional Asian medicine Ephedra formulae often deliverlower amounts of ephedrine alkaloids compared to other types of ephedrine alkaloid-containingproducts and that traditional formulae rarely contain more than 15 percent Ephedra in theherb mixture. Comments also asserted that Ephedra in traditional formulae is usually combinedwith other botanicals that typically modify Ephedra's inherent stimulant effects. Anothercomment attributed the relative safety of Ephedra to the mixture of ephedrine alkaloidisomers not present in purified or synthetic alkaloids. One comment suggested that theestablished therapeutic dose range of Ephedra sinica in herbal medicine formulae is 60 to 90mg total alkaloids per day (adults), which falls within the dosage range established for OTCephedrine/pseudoephedrine-containing drugs (150 mg and 240 mg alkaloids daily,respectively), and the recommendations of the Germany Commission E (maximum dailyEphedra alkaloid dose of 300 mg daily). Other comments asserted that infusions or teas ofEphedra are effective in relieving respiratory symptoms but have fewer side effects and aresafer than formulations containing isolated or synthetic ephedrine alkaloids or prescriptiondrugs. Another comment stated that supplements in a liquid tea form greatly reduce the risk ofexcess acute consumption by the public.04/07/2020 Town Hall MeetingPage 9

In contrast, several other comments stated that the presence of varying amounts, proportions,and chemical configurations of ephedrine alkaloids in crude Ephedra and prepared Ephedraextracts, as well as the presence of unknown compounds, leads to uncertainty as to dose,purity, and composition and to a greater risk of adverse effects. Comments noted that thisvariability is not an issue for synthetic or pure isolated ephedrine alkaloids.Numerous comments, including those by traditional Asian medicine practitioners, also noteddifferences in how the products are used. Several comments stated that most traditional Asianuses of Ephedra are the same as the indications for OTC ephedrine and pseudoephedrinedrugs (e.g., short-term use to improve respiratory function) and that few if any adverse effectshave been recorded. Several comments stated that use of Ephedra (ma huang) for weightcontrol or for its stimulating effects, for more than a short period of time, in combination withcaffeine and other botanical stimulants, and without the supervision of a health care provider, isirresponsible and dangerous. A number of traditional Asian medicine practitioners maintainedthat many consumers experienced adverse effects because of this improper use,over-dosage, or conflict with their illnesses.Because of these differences, many practitioners of traditional Asian medicine commented thatthey support our June 1997 proposal except to the extent that it would restrict their use ofEphedra in traditional Asian medicine. Several comments asserted that since most seriousadverse effects involve use of ephedrine alkaloids and not whole herb or whole herb extracts ofEphedra, any rule must exempt whole herb Ephedra or whole herb Ephedra extracts thatcontain no added ephedrine alkaloids. Furthermore, ephedrine alkaloid-free species ofEphedra should also be exempted.Numerous comments asserted that because traditional Asian herbal products are prescribed byappropriate practitioners (licensed, certified, and registered acupuncturists, herbalists, andnaturopathic physicians) and because these products are not associated with seriousadverse effects, the products do not appear to constitute a public health risk and their useshould not be prohibited. Many traditional Asian medicine practitioners stated that Ephedra isan essential medicine and requested an exemption from the final rule for use of Ephedra bytraditional Asian medicine practitioners and acupuncturists. A few comments asserted thatEphedra should not be used commercially, but be restricted to professional use, to bedispensed by licensed health care professionals trained in the appropriate use of traditionalAsian medicine.(Response) This final rule does not affect the use of Ephedra preparations in traditional Asianmedicine, although we considered the comments' views and information on the use of Ephedrain traditional Asian medicine in the context of their possible relevance to the risks of dietarysupplements containing ephedrine alkaloids. This rule applies only to products regulated asdietary supplements (See 62 FR 30678 at 30691). Traditional Asian medicine practitioners donot typically use products marketed as dietary supplements.With respect to the absence of adverse effects recorded with the use of traditional Asianmedicine, as we stated in the June 1997 proposal, we are not aware of any systematiccollection of data related to adverse effects occurring in individuals treated with Ephedra in04/07/2020 Town Hall MeetingPage 10

traditional Asian medicine. The absence of recorded adverse events with the use of Ephedra,therefore, may be related to the lack of a mechanism for reporting. Under these circumstances,there are no data to evaluate. We note that the potential for adverse effects resulting from thetraditional Asian use of Ephedra is implied in several reference texts that list precautions andcontraindications for the use of the botanical Ephedra in traditional Asian medicine preparations(Refs. 3, 107, and 108). Moreover, even if we could say that the absence of recorded adverseevents with the use of Ephedra in traditional Asian medicine was due to its safety for that userather than due to a lack of mechanism for reporting, the history of use of Ephedra in traditionalAsian medicine primarily for the treatment or mitigation of respiratory illness cannot provideassurance about the safety of dietary supplements containing ephedrine alkaloids for otheruses.Question: If a clerk at your local drug store can sell you a product containing ephedra, why can't alicensed acupuncturist/Chinese Herbalist or an NCCAOM Dipl. of Chinese medicine? That should beincluded in our argument to the FDA & DEA.Answered on 04/10/20: OTC or prescription drugs containing ephedrine alkaloids are notincluded in the FDA Final Rule. For more information, see The US Food and DrugAdministration’s Final Rule Declaring Dietary Supplements Containing Ephedrine AlkaloidsAdulterated Because They Present an Unreasonable Risk; Final Rule, February 11, 2004This final rule also does not include OTC or prescription drugs that contain ephedrine alkaloids.The use of ephedrine or pseudoephedrine for the treatment of asthma, colds, allergies, or anyother disease is beyond the scope of this final rule. Ephedrine is allowed as an active ingredientin oral OTC bronchodilator drugs for use in the treatment of medically diagnosed mild asthma(Sec. 341.16 (21 CFR 341.16)), when used within the established dosage limits and when theproduct is labeled in accordance with the required statements of identity, indications, warnings,and directions for use found in Sec. 341.76. In the near future, we intend to propose revisions toSec. 341.76 to reflect current scientific information about the risks of ephedrine. Both ephedrine(topical) and pseudoephedrine (oral) are permitted as active ingredients for use as nasaldecongestants (Sec. 341.20), when they are used within the dosage limits established by andlabeled in accordance with Sec. 341.80. The topical use of ephedrine will not be furtherdiscussed in this rule because it is not relevant to oral consumption of ephedrine in dietarysupplements. The use of ephedrine alkaloids in drug products is discussed in more detail insection V.B.3 of this document.Question: Is there any information on available herbal alternatives?Answered on 4/10/20: Wei qi and EPF herbs are available. Please see the list above.Practitioners are reminded to use differential diagnosis for the most appropriate formulas to treatthe patient’s presenting signs and symptoms.Question: For Bill Egloff, Why does the herb product list sometimes say that some formulas, “aren’tavailable in my area”? This was before COVID-19?Answered on 4/10/20: Crane Herb Company lists products as “not available in your area” whenproducts are not available or out of stock, specifically when manufacturers cannot provide ETAsfor the products. Please call Crane Herb Company for more information.04/07/2020 Town Hall MeetingPage 11

Telehealth and BillingQuestion: Can we get the new codes the insurance companies have put out for the treatment of thevirus for virtual treatments?Answered on 4/13/20 – Mori West: I want to be clear – NONE of the telehealth codesmentioned in my presentation were to be used for treatment of the virus.If you are using the codes for payment, the treatment must still be for a medically necessarydiagnosis, which is typically a pain related condition.Question: At the April 1, 2020 Town Hall meeting Mr. West mentioned to use code 97802 for theVeterans Administration. Do you have confirmation the VA is accepting it for TriWest?Answered on 4/13/20 – Mori West: I NEVER mentioned using 97802 for the VA, however I haveseen others who recommend billing that code or saying they have been paid when providing thatcode.I WOULD NEVER recommend billing 97802- Medical nutrition therapy, initial assessment andintervention, individual, face to face with patient, each 15 min. First off carriers only pay for thiscode for a limited number of providers (certified nutritionists) and for a limited number ofconditions (end-stage renal disease, diabetes).I have recommended using E/M codes when authorized for the VA and either providing a trueE/M service or using the codes to indicate the majority of time spent was providing counselingand/or coordination of care services. In both cases – documentation must be stellar.Potential Codes for Telehealth ServicesMori West has provided a list of potential codes for telehealth services. Click here to access.NCCAOM Certification and RecertificationNote: The NCCAOM application for certification and recertification must be submitted through yourNCCAOM online portal. All Diplomates are required to report their continuing education for recertificationelectronically in their NCCAOM online portal. Continuing education reporting instructions are availablehere.Question: I live in Maryland and am not required to be a Diplomate. Can I receive CEUs to apply to mystate requirement?Answered on 4/13/20: Per Maryland (F) Continuing Education COMAR 10.26.02.05:(1) A licensee applying for renewal shall complete 30 hours of relevant continuing educationduring the 2-year period preceding the expiration of the license which include the following:04/07/2020 Town Hall MeetingPage 12

(a) At least 20 hours in formally organized programs which are relevant to the practiceof acupuncture and Oriental medicine and are approved by the Board or sponsored by, butnot limited to, the following organizations and their member organizations:(i) – (iv) .(v) National Commission for the Certification of Acupuncture and Oriental Medicine(NCCAOM);(vi) – (vii) .Question: What is the current position that NCCAOM has with ACAOM and individual students andtheir respective schools? There is currently a major issue with students who would have graduated inApril or August and the amount of internship hours that are required to graduate. Is NCCAOM aware ofthis issue and if so, what is being done about it?Answered on 4/07/20: The NCCAOM is not involved in any way with the school curriculum ortheir teaching methods and must maintain a distance from the education required for certificationbased on the National Commission of Certifying Agencies (NCCA) standards, NCCAOM’scredentialing agency. This is why the NCCAOM certification relies on a third-party educationstandard; degrees in the U.S. earned at a school accredited by the Accreditation Commission forAcupuncture & Oriental Medicine (ACAOM). During this uncertain time the schools are workingto make sure that any changes to their curriculum are approved by ACAOM so that you can beassured you are graduating from a program that has maintained its ACAOM accreditation.ACAOM has posted updates for the schools on their website "Regarding COVID-19 and ClinicalTraining (2 April 2020)". The website for ACAOM if you would like further information iswww.acaom.org.ACAOM will be one of the presenters at the NCCAOM / ASA Town Hall Meeting this Tuesday,April 14, 2020. Click here to register.The NCCAOM has made multiple temporary emergency changes to the examination process dueto the closing of the Pearson VUE testing centers and the cancelation of the in-person Council ofColleges of Acupuncture and Oriental Medicine (CCAOM) Clean Needle Technique (CNT)program courses. If you are a student due to graduate in 2020 the NCCAOM is working withyour school to ensure you are able to begin the testing process prior to graduation. The studentwill need to:1. Contact the school to confirm you are eligible for a 2020 graduation date.2. Once the school submits your graduation class information to NCCAOM, you will becontacted by NCCAOM and guided through the application process.3. Request your CNT course verification from CCAOM once your application for certificationwith NCCAOM has been completed.a. Applicants who have not previously completed the in-person CCAOM CNT coursemust register for a future CCAOM CNT program course and submit the CCAOMconfirmation registration letter to the NCCAOM at covid19alerts@thenccaom.org.Final NCCAOM certification requires (1) successfully passing all required NCCAOM certificationexams, (2) receipt of the CCAOM CNT certificate of completion directly from the CCAOM toNCCAOM, and (3) receipt of the official final graduation transcript from the school.04/07/2020 Town Hall MeetingPage 13

Due to the test center closings the NCCAOM canceled the linear exam administration to beginApril 27, 2020. To accommodate candidates NCCAOM will be implementing the year-roundadaptive exam a

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