SB 175-PRACTICE OF NATUROPATHY  2:18:41 PM CHAIR EGAN announced SB 175 to be up for consideration. 2:18:45 PM SENATOR LESIL MCGUIRE, sponsor of SB 175, said this measure would correct an oversight in statute and regulation with respect to the practice of naturopathic medicine in the state. It would allow prescribing of naturopathic concentrates that are extracts of a plant, tree, tree root, moss, fungus or other natural substance that is not a controlled substance. It is part of the existing regulation in 12 AAC that naturopathic practitioners are specifically allowed to prescribe. She said there are 43 naturopaths in the state: 16 in Anchorage, 2 in Eagle River, 2 in Palmer, 15 in Fairbanks, 1 in Seward, 2 in Kenai and Homer, 1 in Sitka and 4 in Juneau. They have been practicing under a licensing statute that was put into law in 1987. Alaska is one of 15 states that specifically license naturopathic doctors. Other states give a broader range of prescriptive authority; 11 of them give prescriptive authority for those substances that are not controlled and 4 of them actually give naturopaths prescriptive authority for substances that are controlled as well. 2:22:32 PM Alaska is the one state that licenses naturopathic physicians but doesn't allow them to prescribe controlled substances. However, an exception was made in regulation and today they want to put that regulation into statute for clarity. SENATOR MCGUIRE said the issue came up when some naturopathic physicians who had been prescribing these natural remedies for their patients had their prescriptions suddenly denied at the pharmacy. They were told it was at the direction of the licensing board that stated the Alaska statute was unclear. She said her opinion is that nothing in this bill expands the authority of naturopathic physicians practicing in the state. In fact, they will continue to do everything they are doing, but it will be put into law. She said a proposed amendment by Senator Giessel provides further clarity by adding dietetic remedy, homeopathic remedy and hydrotherapy to the language. SENATOR MCGUIRE said one example of a remedy is cayenne pepper that is used as a sore throat remedy when mixed with alcohol. The bottle is specifically labeled with requirements and a shelf life, and says it's licensed by the FDA. GENEVIEVE WOJTUSIK, staff to Senator McGuire, explained that Section 1 describes what a naturopath is restricted from doing and Section 2 amends AS 08.45.050 to allow a person who practices naturopathy "to give, prescribe or recommend a medicine that is derived from or is a concentrate of or is an extract of a plant, tree, root, moss, fungus or other natural substance if the medicine is not a controlled substance." Section 3 provides for an immediate effective date. 2:27:01 PM CHAIR EGAN objected for public testimony. 2:28:52 PM At ease from 2:28 to 2:31 p.m. 2:31:15 PM CHRISTINE NIEMI, representing herself, Douglas, Alaska, said her primary choice for health care is a naturopathic doctor and that is why she is testifying today in support of SB 175. She said she understands that some therapies and natural herbal medicines have been denied to some patients. It is wrong to deny a profession the ability to provide services within the scope of their practice, their medical education and training. It is also wrong to deny services that are needed by their patients. 2:33:16 PM C.W. JASPER, Alaska Association of Naturopathic Physicians, said that there are actually 16 states that license naturopathic doctors and of those, 11 give prescriptive authority and 5 allow controlled substances. The profession is growing tremendously. He said he has been asked why he came here if these other states license naturopathic doctors and the reason is because he is a fourth generation Alaskan. His great grandfather came over the Chilkoot Pass in 1898 and his family held gold claims in Juneau. He said he practices here because it is his home. MR. JASPER said his ability to practice here is dependent on legislative authority; and in 1986 a bill was passed with the definition of the practice of naturopathy. The terminology was picked by Fred Zharoff. 2:36:02 PM He said herbal remedies are the heart and soul of what they do. Cayenne pepper is a good example; taking it makes your nose run. So, medically speaking it is an expectorant. People ask why you can't just put ground-up pepper in capsules, but the problem is that as soon as the pepper is ground it begins to deteriorate to a point where it loses its potency. In prescription form cayenne pepper is called capsicum and it is prepared according to a national standard so people get a predictable result. When it's prepared in the medical form, it has the legend on it. It's not a prescription drug, but a prescription medicine that you need authority from the state to use. MR. JASPER explained that in 1986 Senator Zharoff tried using the definition of "medicine" as proposed to prohibit naturopaths from using any prescription medicine. It was very broad and would include even capsicum tincture to which Mr. Jasper said he couldn't agree. So they came up with this version, prohibiting "prescription drugs," which they considered a much narrower definition. The definition of "drug" is a chemical substance and a chemical is something that is produced from a chemical process. So, naturopaths agreed that they would be prohibited from prescribing prescription drugs, but not prescription medicines. The medicines on this list, such as capsicum and valium, were the things they were being allowed to prescribe because they weren't prescription drugs (they were prescription medicines). The bill gave directions to the state to adopt regulations that would define the natural medicines naturopaths could use. So, they said okay and did it. Everybody agreed. So, this is the regulation they adopted 18 years ago and it's part of the administrative code now. AS 08.45 says that "prescription drug" does not include a device or herbal or homeopathic remedy. The state acknowledged their understanding that herbal remedies would not be considered prescription drugs in its statute. Then they defined "herbal remedy" to be "medicines derived from or a concentrate or extract of a plant, tree, root, moss, fungus or other natural substances." Things were settled and Mr. Jasper said he took these regulations around and showed them to Anchorage pharmacists who understood and agreed. 2:41:59 PM He said on the State of Alaska website to apply for a naturopathic license has a statement reminding people that statutes and regulations have the force of law. So even though it's been clear to everybody and they have practiced under this interpretation for 18 years, pharmacies are now saying they can't give these medicines to naturopaths anymore. Their solution is to ask the legislature to put this regulation [12 AAC 42.990] into statute. 2:44:00 PM SENATOR PASKVAN asked the reason for the change by the licensing board. MR. JASPER said he couldn't answer that because he didn't know the internal mechanics of why this is happening. SENATOR PASKVAN said he wanted to know what happened if there wasn't a problem for 18 years. SENATOR MENARD asked how much of a concern there is about using a syringe to administer the vitamin B12 or vitamin C. MR. JASPER said he didn't know if that was a concern, but naturopaths give B12 shots and they need a device to do that. Syringes have a warning similar to the capsicum that says federal law prohibits purchasing them without a prescription or words to that effect; that is why the original regulation said the device would not be barred from use by naturopaths. 2:46:03 PM SENATOR MENARD asked if pharmacists are refusing to let them buy the device as well. MR. JASPER replied that he didn't know for sure but didn't think it was an issue; it's mainly being deprived of access to medicines. SENATOR GIESSEL said that definition of naturopathy includes more aspects than simply the herbal remedy; it includes dietetics, homeopathic and hydrotherapies, and asked if he would be open, if necessary, to include the definition of those other modalities as well. DR. JASPER said he wouldn't object to that and would leave it up to the legislature to determine whether that was necessary. SENATOR GIESSEL said if this was the only definition in statute it may, by omission, fail to allow him to provide dietetic, homeopathic and hydrotherapeutic modalities. CHAIR EGAN invited Mr. Habegar to answer Senator Paskvan's question and to provide additional information from the department. 2:47:53 PM DON HABEGAR, Director, Division of Corporations, Businesses and Professional Licensing, Department of Commerce, Community and Economic Development (DCCED), said the question was what the division is doing differently and the answer is not a whole lot. He explained there is no board for naturopathy; it is a division-run licensing program. However, this issue has been before them for quite some time and there was a recent change. When the licensing law was being considered by the legislature it was his division's understanding and many in the health care profession that the language in statute AS 08.45.050 essentially barred naturopaths for prescribing items that are normally obtained through a pharmacy. In 1996, a letter from then Director Reardon to a licensee stated the division's position as follows: If a product requires a prescription, then it is a prescription drug and a naturopath may not give prescribe or recommend it under AS 08.45.050. Another quote: The definition of prescription drug in regulation 12 AAC 42.990 is consistent with my interpretation of the law. Another quote: It was not intended to allow naturopaths to prescribe drugs refined and manufactured from plants. Instead, it was recognition of naturopaths' use of herbs in their basic natural form. MR. HABEGAR said the division is not changing an interpretation but is using a pathway that was set long ago. That same letter of 1996 recognized the possible need to clarify regulation. 2:51:26 PM SENATOR PASKVAN said he understood the 1996 letter, but the question is if what was occurring in 2010 being prohibited in 2012. MR. HABEGAR replied that the division is not changing any of its practices. One of the things that has transpired is that in 1996 a licensee asked the division if he/she could prescribe certain things. The letter he quoted was a response to that and the answer was no. SENATOR PASKVAN asked if what was allowed in practice in 2010 prohibited in 2012: yes or no. MR. HABEGAR replied no. SENATOR PASKVAN asked if naturopaths could obtain this from pharmacies in 2010. MR. HABEGAR answered from the division's perspective, no. SENATOR PASKVAN asked if they had been obtaining these remedies or concentrates from pharmacies for many years. MR. HABEGAR said he couldn't answer that; it was before his time with the division. SENATOR PASKVAN asked what happened recently that caused him to enter an order to pharmacies to cease what appears to be a long- lasting practice. MR. HABEGAR replied that the division brought an allegation against a licensee for prescribing and that brought the issue to a head. It clarified for the division what was happening in the practice. 2:54:18 PM SENATOR GIESSEL said Mr. Habegar read the definition of "prescription drug," from a letter that cited 12 AAC 42.990, but the regulation was not completely stated. The last half of the definition says: "prescription drug does not include a device or herbal or homeopathic remedy or dietetic substance in a form that is not a controlled substance." She referred back to other definitions in section .990; it defines dietetics, nutritional therapies, substances, vitamins, minerals et cetera. Number 3 says "herbal remedy" includes "medicines derived from a concentrate or extract of a plant, root, moss et cetera" and number 4 says "homeopathic remedy" means "a remedy defined by the homeopathic pharmacopeia of the United State, December 1993 version," and "hydrotherapy" means "the use of water." It is pretty clear in this regulation that prescription drug is not a device, herbal substance (what Mr. Jasper just elucidated), a homeopathic remedy or dietetic substance. Senator Giessel opined that Director Reardon misapplied and misinterpreted those regulations and it's now being applied in a much more restrictive way not in accordance with what the regulations clearly say. MR. HABEGAR replied that the Department of Law (DOL) has advised that that Director Reardon's wasn't a bad interpretation and he has continued down that pathway. 2:56:58 PM SENATOR GIESSEL said because of that vague interpretation she wanted to amend this bill to make it much more precise in terms of including dietetic remedy, herbal remedy, homeopathic remedy and hydrotherapy as in the purview of the naturopath in statute. 2:57:42 PM SENATOR PASKVAN said he is troubled in looking at 12 AAC 42.990 that the history section indicates it was effective in 1994 and amended in 2006, but the regulation was amended after the letter was written in 1996 and the practice still continued. He didn't know how the department could argue its position, because it seems grossly different from the history of that regulation. MR. HABEGAR responded that when positions turn over with administrations there is often a great deal of trying to figure out historical context. In that light and having been advised, it seems to him that the division set a path that was consistent with what it considered was happening. They also determined to continue down that pathway. CHAIR EGAN said he wanted a further explanation for the change, from a doctor. 3:00:28 PM SENATOR GIESSEL moved to adopt Amendment 1. 27-LS1230\M.4 Martin AMENDMENT 1  OFFERED IN THE SENATE By SENATOR GIESSEL Page 1, line 13, through page 2, line 2: Delete all material and insert:  "* Sec. 2. AS 08.45.050 is amended by adding new subsections to read: (b) Notwithstanding (a)(1)(A) of this section, a person who practices naturopathy may give, prescribe, or recommend in the practice a device or, in a form that is not a controlled substance, an herbal or homeopathic remedy, a dietetic remedy, or hydrotherapy. (c) In this section, (1) "dietetic remedy" means nutritional therapy, nutritional counseling, a nutritional substance, vitamins, minerals, or supplements to promote health and to diagnose, treat, or prevent disease, illness, or conditions; (2) "herbal remedy" means a substance derived from or a concentrate or extract of a plant, tree, root, moss, or fungus; (3) "homeopathic remedy" means a remedy defined in the current version of Homeopathic Pharmacopoeia of the United States; (4) "hydrotherapy" means the use of water in all forms and temperatures to promote health and to diagnose, treat, and prevent disease, illness, and conditions." CHAIR EGAN stopped the hearing saying the committee would continue public testimony on SB 175 at the next meeting.