ALASKA STATE LEGISLATURE  SENATE HEALTH AND SOCIAL SERVICES STANDING COMMITTEE  February 15, 2017 1:32 p.m. MEMBERS PRESENT Senator David Wilson, Chair Senator Natasha von Imhof, Vice Chair Senator Cathy Giessel Senator Tom Begich MEMBERS ABSENT  Senator Peter Micciche COMMITTEE CALENDAR  SENATE BILL NO. 36 "An Act relating to the practice of optometry." - MOVED SB 36 OUT OF COMMITTEE SENATE BILL NO. 32 "An Act relating to biological products; relating to the practice of pharmacy; relating to the Board of Pharmacy; and providing for an effective date." - MOVED SB 32 OUT OF COMMITTEE PREVIOUS COMMITTEE ACTION  BILL: SB 36 SHORT TITLE: OPTOMETRY & OPTOMETRISTS SPONSOR(s): SENATOR(s) GIESSEL 01/25/17 (S) READ THE FIRST TIME - REFERRALS 01/25/17 (S) HSS, FIN 02/03/17 (S) HSS AT 1:30 PM BUTROVICH 205 02/03/17 (S) Heard & Held 02/03/17 (S) MINUTE(HSS) 02/15/17 (S) HSS AT 1:30 PM BUTROVICH 205 BILL: SB 32 SHORT TITLE: PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS SPONSOR(s): SENATOR(s) HUGHES 01/23/17 (S) READ THE FIRST TIME - REFERRALS 01/23/17 (S) HSS, L&C 02/10/17 (S) HSS AT 1:30 PM BUTROVICH 205 02/10/17 (S) Heard & Held 02/10/17 (S) MINUTE(HSS) 02/15/17 (S) HSS AT 1:30 PM BUTROVICH 205 WITNESS REGISTER DR. PAUL BARNEY, Chairman Board of Examiners in Optometry Corporations, Business & Professional Licensing Department of Commerce, Community, and Economic Development Juneau, Alaska POSITION STATEMENT: Testified in support of SB 36. DR. JEFF GONNASON, Legislative Chair Alaska Optometric Association Anchorage, Alaska POSITION STATEMENT: Testified in support of SB 36. SENATOR SHELLEY HUGHES Alaska State Legislature Juneau, Alaska POSITION STATEMENT: Sponsor of SB 32. JANE CONWAY, Staff Senator Giessel Alaska State Legislature Juneau, Alaska POSITION STATEMENT: Provided an overview of Amendment 1 for SB 32. ACTION NARRATIVE 1:32:58 PM CHAIR DAVID WILSON called the Senate Health and Social Services Standing Committee meeting to order at 1:32 p.m. Present at the call to order were Senators von Imhof, Begich, Giessel, and Chair Wilson. SB 36-OPTOMETRY & OPTOMETRISTS  1:33:22 PM CHAIR WILSON announced the consideration of SB 36. He welcomed invited testimony to address SB 36. 1:34:05 PM DR. PAUL BARNEY, Chairman; Board of Examiners in Optometry, Corporations, Business & Professional Licensing; Alaska Department of Commerce, Community, and Economic Development; Juneau, Alaska; testified in support of SB 36. He noted that he has served on the board for five years and was also the director for Pacific Cataract and Laser Institute in Anchorage, Alaska. He detailed that his practice specializes in cataract care, laser vision correction, and medical eye-care. He pointed out that he works with an ophthalmic surgeon and an advanced- practice nurse; together they work as a team and use their training to provide care more efficiently and affordably. He emphasized that SB 36 would not allow optometrists to do anything more than what they have already been trained to do. He specified that there is a limitation that would prevent optometrists from writing regulations beyond the scope of their training. He revealed that the Alaska the Department of Law oversees all health-care boards; consequently, the Board of Examiners in Optometry has to prove that optometrists are trained for the regulations that they write. He asserted that the Alaska Department of Law oversight acts as a fail-safe to prevent optometrists from doing something outside of their scope of training. He added that as a provider, if he were to do something outside of his scope of training, his medical malpractice insurance would be immediately negated. He summarized that there really is no incentive for optometrists to provide care that they are not trained to do because they would not get paid and more importantly, optometrists could end their careers by doing something outside of their scope of training. 1:37:11 PM DR. JEFF GONNASON, Legislative Chairman, Alaska Optometric Association, Anchorage, Alaska, testified in support of SB 36. He disclosed that he has been licensed as an optometrist in Alaska for 40 years, the past chairman of the Board of Examiners in Optometry, and served twice on the state board in the past under two different governors. He added that he was also a 22- year volunteer for the American Optometric Association. He pointed out that optometrists' education is exactly the same as a dentistry-model with 8 to 10 years of university-level education. He addressed testimony from an ophthalmologist during an earlier committee meeting and noted that he had the same professor for pharmacology as the ophthalmologist. DR. GONNASON disclosed that optometrists are defined as physicians under federal Medicare and that has been the case for approximately 18 years. He divulged that 160-plus optometrists serve over 80 communities in the state. He set forth that optometrists work together very well with general-family doctors and ophthalmologists. He opined that optometrist training cannot be compared to ophthalmologist training because it would be like comparing a family physician with a neurosurgeon. He summarized as follows: We need ophthalmologists, we love having their abilities to do their surgeries, we only overlap in a small area; but, we do very few of the things that they do and we are not trying to do things that are outside of our scope of training. Of the four- prescribing professions, only optometry has to always come back to, "Ask daddy for permission" to change something as technology goes along. We are very skilled in using our professional judgement to know when to refer patients. 1:39:56 PM SENATOR BEGICH revealed that Dr. Barney did his Lasik eye surgery. DR. BARNEY clarified that Dr. Ford from Seattle did Senator Begich's surgery. He specified that he did the preoperative evaluation and the postoperative care. SENATOR BEGICH disclosed that he had talked earlier with Dr. Barney and Dr. Gonnason to express his concerns about the Legislature's responsibility to public safety. He said he asked both doctors about the importance in clarifying surgery in a way that would meet the American Medical Association's health concerns as well as meet some of the needs and interests of what optometrists in Alaska are doing. He said he suggested to Dr. Barney that language around surgery might be required and noted that Dr. Barney appeared to respond that his suggestion made sense. He asked Dr. Barney to comment on the idea of a tighter surgery definition to help committee members understand what the optometrists are seeking in statute. 1:42:06 PM DR. BARNEY replied that if necessary, he is not opposed to language that further defines surgery. SENATOR BEGICH set forth that his hope is the committee can come to a conclusion that further defines surgery. 1:44:03 PM DR. GONNASON remarked that part of the difficulty is that "forces" have tried to suppress the optometrist profession for a long time. He said to answer Senator Begich's question on surgery, the problem is everyone knows what surgery is, but trying to define surgery can get murky. He pointed out that clipping a finger nail alters tissue and can be considered surgery. He noted that some states have defined surgery for physicians and dentists. He remarked that putting a surgery definition in SB 36 would apply to other fields too, unless exempted. He opined that details should be left to the medical, dental, and nursing boards. He pointed out that there in nothing in the nursing statute that says, "You will not do brain surgery" because nurses do not do that. He asserted that there's no need for defining surgery in the optometry law that says, "You will not do these 16 things." He noted that a proposal came out to put 110 procedures that could not be done in statute, a proposal that made no sense. He emphasized that optometrists perform procedures that do not "penetrate." He added that optometrists do not do the things that ophthalmologists claim optometrists will be trying to do. 1:46:26 PM SENATOR BEGICH stated that Dr. Gonnason's reply is more difficult for him to understand. He said he thought Dr. Gonnason provided a clear answer that surgery as a definition might be something that he would entertain. He continued as follows: You understood that concern and we do have a definition of surgery in statute and admittedly part of why we have a legislative-affairs agency here that drafts bills is that they look at other statutes where those definitions will conflict, and they identify in those statutes where they do and they allow us to know that in the process because all of us are generally generalists here. With that understanding, a definition of surgery is a norm in many states and I've provided to some members of the committee some of those definitions that I've researched some myself. I am now confused whether you are or are not willing to look at a definition of surgery in statute because I've heard you now say "no," and I heard Dr. Barney say "yes." So which is it, I'm confused. DR. GONNASON clarified that he did not mean he would not look at a definition of surgery. He specified that he was trying to explain why defining surgery is difficult and pointed out that most states address through regulation. He remarked that laws are different in all 50 states due to legislative compromise that results in optometrists having to go back and ask for permission when new technology comes along rather than having the board be able to say "yes" when an optometrist is trained for a procedure. 1:48:29 PM SENATOR VON IMHOF addressed Dr. Gonnason's remarks as follows: Trying to create a bill, any bill, so open ended that it precludes having to go back and change statute as technology changes, as circumstances changes, is probably too difficult in any industry. I'm already noticing that we are tweaking things now in this legislature for all sorts of different things as new chemicals come about, as new technology comes about, as new laws come about, that's just the nature of the beast, I think. That being said, what I'm understanding is that this particular conflict has been around for quite some time and I understand the challenge of optometrists having to come legislatively every single time, it's not cost effective for any stakeholder. So the key is to stop this nonsense and to move forward that while we may find a solution that not everyone is happy with, everyone can live with. I think what's important is Senator Begich and I and a few others have looked at what other states have done, some are more onerous than others, but some have tried to thread-the-needle to make it make sense for all parties. I think what Senator Begich was asking you today for a deliverable is to perhaps, could you take a first crack at what you think based on other states' legislation, what might make sense. 1:50:28 PM At ease. 1:50:38 PM CHAIR WILSON called the committee back to order. SENATOR GIESSEL said she was thrilled that Senator Begich has done research on the definition of surgery, but noted that she was one of the committee members that did not receive his information. She asked Dr. Barney to address the number of patient complaints that the Board of Examiners in Optometry has received in the last decade. DR. BARNEY answered that there have been some complaints, but no complaints that required disciplinary action over the past ten years. SENATOR GIESSEL asked Dr. Barney if the Board of Examiners in Optometry was in good standing financially with regards to licensing fees covering their costs. DR. BARNEY replied that the board is currently in good standing. He noted that the last scope-of-practice bill passed 10 years ago and the board had to address legal expenses implemented from the scope-of-practice change. SENATOR GIESSEL asked Dr. Barney to clarify the legal issues that he referenced. 1:52:57 PM DR. BARNEY specified that the Alaska Department of Law billed the board for their investigative work involved with the scope- of-practice change. He detailed that license fees were not increased, and the board fell behind, but noted that the board will be caught up in the next cycle. SENATOR GIESSEL asked him to verify that the board pays the cost in implementing regulatory changes and the funding ultimately comes from licensees. DR. BARNEY answered correct. CHAIR WILSON asked for final comments from the bill's sponsor. 1:54:15 PM SENATOR GIESSEL summarized intent and issues of SB 36 as follows: I think Senator von Imhof really encapsulated it, this has been an issue that has been discussed multiple times over at least a decade, it continues to take time in this legislature; in that time optometrists have been practicing safely. You've heard testimony that professional complaints against their practice are zero. I think it is time to allow this board to function as other boards do. I have the definitions of the scope-of-practice for the four boards that currently have authority over their regulation, over their regulatory authority and that is: nursing, physicians, dentistry, and pharmacy. All are extremely broad, I will speak only of my own advanced nurse practitioner scope-of-practice, it means that, "A registered nurse authorized to practice in the state, who because of specialized education and experience, is certified to perform acts of medical diagnosis and the prescription and dispensing of medical, therapeutic or corrective measures under regulations adopted by the board." One of the really interesting ones is for the scope- of-practice for medicine and osteopathy. Osteopaths are not medical doctors, they are doctors of osteopathy, this is a subspecialty so to speak that believes that adjustment of the spine is often an answer to medical problems, they however fall into the same definition and says, "For a fee, donation or other consideration, to diagnose, treat, operate on or prescribe for or administer to any human ailment, blemish, deformity, disease, disfigurement, disorder, injury or other mental or physical condition, or to attempt to perform or represent that a person is authorized to perform any of the acts set out in the subparagraph;" I think listening to that you can hear that the practice of medicine is all encompassing of everything possible that could happen to a human being. We don't worry that a family practice doctor is going to attempt heart surgery, we don't worry about that. I suggest that the same reasonable outlook could be applied to optometry. 1:56:39 PM CHAIR WILSON announced that hearing no call for amendments, asked for a motion to move SB 36 out of committee. 1:56:51 PM SENATOR VON IMHOF moved to report SB 36, [30-LS0328\A], from committee with individual recommendations and attached fiscal note(s). 1:57:02 PM CHAIR WILSON announced that seeing no objection SB 36 moved from the Senate Health and Social Services Standing Committee. 1:57:15 PM At ease. SB 32-PRESCRIPTIONS FOR BIOLOGICAL PRODUCTS  1:58:35 PM CHAIR WILSON called the committee back order. He announced the consideration of SB 32. He summarized that the committee heard a bill overview and had taken public testimony on February 10. He asked that Senator Hughes, the bill sponsor, provide final comments on SB 32. 1:59:06 PM SENATOR SHELLEY HUGHES, Alaska State Legislature, Juneau, Alaska, sponsor of SB 32, stated she was available to answer questions. SENATOR BEGICH noted that he received a letter from the Alaska State Medical Association (ASMA) that indicated opposition to SB 32. He detailed that ASMA proclaimed that SB 32 was not as permissive as it needed to be because biosimilars are perceived by the FDA to be considerably safe. SENATOR HUGHES replied that she was surprised by the ASMA letter because she received an earlier letter from a physician who requested notification and prior authorization. She remarked that ASMA has indicated their belief that the FDA process and approval of biosimilars for substitution at the "silver standard" level would be fine versus the "gold standard" of interchangeable. She opined that biosimilars are new and because the FDA does plan to have additional criteria for the interchangeable "gold standard," SB 32 should be left as is in order to provide another level of safety. She set forth that a prescriber needs to stay in the "driver's seat" with the ability to write, "Dispense as written" or "Call if substitute available". SENATOR HUGHES detailed that the FDA criteria for interchangeable is very strict: 1. The interchangeable first has to be classified as a biosimilar. 2. The biosimilar must be expected to produce the same clinical results as the original-biologic product in any given patient. 3. The risk in terms of safety and efficacy of alternating or switching between the use of an interchangeable and the original biologic is not greater than the risk of continued use of just the original biologic product. 2:02:45 PM She noted health-care provider groups that announced their support as follows: · Every state medical society, · The American College of Rheumatology, · The National Medical Association, · The American Association of Clinical Endocrinologists, · The American Association of Neurological Surgeons, · The American College of Mohs Surgery, · Association of Black Cardiologists, · American Society of Plastic Surgeons, · The Congress of Neurological Surgeons, · The National Hispanic Medical Association. She emphasized that the list consisted of health-care providers, not just patient-advocacy groups. She opined that the groups looked hard at the legislation and the consensus language that was reached seems to be appropriate. She reiterated that maintaining the interchangeable "gold standard" is what's best for Alaskans. 2:04:02 PM CHAIR WILSON asked Senator Hughes to address a $4,500 Department of Commerce, Community and Economic Development fiscal note for the bill. SENATOR HUGHES concurred that the fiscal was a little odd. She remarked that she is not accustomed to departments that ask for funding to write a minor set of regulations. She noted that the fiscal note can be addressed in the Senator Labor and Commerce Committee, the next committee of referral. SENATOR GIESSEL pointed out that the fiscal note analysis was referenced on page 2 of the fiscal note. CHAIR WILSON asked if there were any amendments for SB 32. 2:05:33 PM SENATOR GIESSEL offered Amendment 1: 30-LS0188\J.1 Bruce 2/14/17 AMENDMENT 1 OFFERED IN THE SENATE BY SENATOR GIESSEL TO: SB 32 Page 2, line 17: Delete "equivalent drug product or interchangeable biological  product" Insert "(1) equivalent drug product; or  (2) interchangeable biological product after obtaining  authorization under (c) of this section"    Page 2, line 25, following "shall": Insert ", before dispensing the interchangeable biological product," Page 2, line 26: Delete "biological product" Insert "proposed biological product that may be" Page 2, line 27, following "product": Insert ", and obtain authorization from the prescribing practitioner" Page 2, lines 27 - 29: Delete "The communication must be provided within three business days after dispensing the biological product as follows:" Insert "The communication may be provided as follows:" Page 3, line 10, following "information": Insert "to or obtain authorization from the prescribing practitioner" Page 3, line 19, following "information": Insert "and obtain the authorization" Page 3, lines 21 - 22: Delete ", without the prescriber's expressed authorization," Page 3, line 23, following "(A)": Insert "without the prescriber's expressed authorization," Page 3, line 25, following "(B)": Insert "with the prescriber's authorization," 2:05:40 PM SENATOR VON IMHOF objected for discussion purposes. 2:06:14 PM At ease. 2:06:42 PM CHAIR WILSON called the committee back to order. 2:06:48 PM JANE CONWAY, Staff, Senator Giessel, Alaska State Legislature, Juneau, Alaska, summarized that Amendment 1 requires that communication must be provided and authorization obtained from the prescribing practitioner prior to dispensing the medication, the interchangeable biological product. She explained the changes as follows: Page 2, line 17:  Page 2, line 17: adds "or interchangeable biological product." It also adds "interchangeable biological product after obtaining authorization" under "C" of this section. Page 2, line 25:  Following "shall", insert "before dispensing the interchangeable biological product"; again, just emphasizing that these things shall happen before the dispensing of the product. Page 2, line 26:  Deletes the words "biological product" and inserts "proposed biological product that may be" dispensed. Page 2, line 27:  Following "product", inserts the words "and obtain authorization from the prescribing practitioner". Page 2, lines 27-29:  Deletes the line, "The communication must be provided within three business days after dispensing the biological product as follows:", that whole line is deleted and inserted instead is, "The communication may be provided as follows:", and then it goes on to show how those different communications can be done. Page 3, line 10:  Following "information", inserts the words, "to or obtain authorization from the prescribing practitioner". Page 3, line 19:  Following "information", inserts the words, "and obtain the authorization". Page 3, lines 21-22:  An error to a comma that was caught during the draft of the amendment, delete "',' without the prescriber's expressed authorization". Page 3, line 23:  Following "(A)" inserts, "without the prescriber's expressed authorization". Page 3, line 25:  Following "(B)" inserts, "with the prescriber's authorization". All of these changes have to do with the intent of that amendment to have all of the communication be provided and authorized before the dispensing of the drug. 2:10:32 PM SENATOR GIESSEL spoke to Amendment 1 as follows: We held public testimony on this bill last week. My concern is that the testimony was solely from those individuals who advocates for the bill. Oral history last week had 7-national organizations advocating for this bill and 4-local organizations, there was no oppositional testimony. In the letters, written documents, we have 16-national organizations advocating and 1-local organization, and 2-local folks are opposing this; those local folks were never heard from, so I'm actually speaking on behalf of them, I'm actually told that one of those local individuals who wrote a letter was asked to withdraw her letter, that concerns me. The argument that's put forth in the most recent document I received today, in fact an hour or so, came from the Arthritis Foundation and I've heard this argument before that such an amendment that I'm offering would conflict with federal law, because the federal law allows this without the substitution, without intervention of the health-care provider, and this is asserted to be a reason that the state of Alaska cannot be more strict and I'm no lawyer, but I contested that assertion. I believe state law can be more restrictive than federal law, so I don't believe that negates the amendment. I'm a clinician, it has been asserted that if the FDA approves this, it's got to be okay. I have heard from specialists who use these medications that these are unique proteins that act uniquely in each one of us in a different way and that switching from one protein to the other, in other words these allegedly interchangeable products actually diminishes the effectiveness of these unique proteins in the individual's body, that concerns me. The second thing that concerns me is FDA approval being asserted as a "gold standard." About 15 years ago, the Varivax vaccine was approved by the FDA, this is a vaccination for children to prevent the occurrence of chicken pox. I worked at a pediatric clinic at that time and we gave one of the first Varivax vaccines in this state; a week later that two- year old came in and could no longer walk, his verbal skills were significantly impaired, and he was having a reaction to this Varivax vaccine. FDA does not mean that there will not be adverse events; that sticks in my mind as the question I always put behind someone who says, "FDA approves it, it must be okay." I also question, and I have heard from a pharmacist that they are not sure they have a concern about this, but I have concerns for the pharmacist's liability. So the pharmacist is now making a decision to change this very unique protein medication without discussion with the clinician, change it to a different formulation. So the clinician has the health records of this individual, the clinician knows a lot about the patient and he has chosen, he or she, has chosen this unique protein medication, wonderful medications, and now the pharmacist is unilaterally going to change that without consultation with the clinician. I contend that there's going to be a liability for that pharmacist if there's an adverse outcome; that of course can only be tested in a court of law, that's a very expensive process. So that's my reason for offering this amendment. I don't believe this has to be rushed, I don't believe this needs to be done without the team that makes up health care: the clinician, the pharmacist, and the patient, all consulting together for the best outcomes. 2:15:27 PM CHAIR WILSON asked if there was further objection to the amendment. SENATOR BEGICH announced that he objected to Amendment 1. He explained his objection as follows: As Senator Giessel duly noted in a duly noticed public hearing that all of the proper, appropriate notice required by law, a number of organizations testified on this bill and anyone was able and had opportunity to testify on this bill. We had testimony, as she points out, that was overwhelmingly in favor of this legislation. I also take note of some of the comments from the Arthritis Foundation, which I also received today and would note that there's a question here of the amendment proposed potentially delaying prescription service, but I want to go further and since we are talking about personal stories, a member of my own staff is a beneficiary of these products. My staffer who is in the audience, Richard Benavides, suffers from cancer, uses these and has identified to me that the ability to have rapid access to what are known to be safe procedures is something that he finds is essential to his wellbeing. I would argue that our duty here is to allow a public process and then through that public process, adjust if necessary a bill. We have done that public process, the testimony overwhelmingly favored the bill as is or in fact moves in the opposite direction of what Senator Giessel is proposing. We will have further committees and there will be further opportunity, but at this time I just want to express my objection to that amendment and would urge the members to not support this amendment. 2:17:56 PM SENATOR GIESSEL clarified that public testimony did not allow opposition. She set forth that the individuals who opposed the bill were online and were not allowed to testify because the meeting ran out and public testimony was closed; consequently, their voice was not heard. She explained that Amendment 1 does not limit access to biologics in any way. She specified that the interchangeables, which are addressed in the bill, are not yet available and may not be available for several years. She asked what the rush is. CHAIR WILSON noted for the record that some of the comments for and against were publicized and made available on the internet for folks to see. SENATOR VON IMHOF commented on Amendment 1 as follows: I very much appreciate the robust dialogue and thank you Senator Giessel, you brought up actually some interesting points that gave me pause today and made me think, it's interesting trying to digest the information that comes in associated with all of these bills, both in the written form and in the verbal form. As we sit here, I feel that it is best to try to, again, to use my words I said in the previous bill, thread-the-needle and try to find the best-foot- forward based on the information that we have in front of us. I understand the concern with the FDA, I don't share those same concerns; I believe that it is a very robust and successful entity and that their analysis gives me comfort. I also see in the letter we received today that biosimilars have been used in Europe with excellent safety and efficacy profile since 2006, and have resulted in significant cost savings. Health-care costs in Alaska is a significant issue as we can all attest and if there's no clinical, meaningful differences between biologic and the reference biological in terms of safety, purity and potency, yet it provides a cost difference, then I think it makes sense to go forward with this. I understand that there are no biosimilars on the market now, but yes it could be years from now, or it could be months from now, we don't know. So as a good boy scout it's best to be prepared. I'm going to vote for the pure form of this bill and not support the amendment. 2:21:40 PM A roll call vote was taken. Senator Giessel and Chair Wilson voted in favor of Amendment 1; Senators Begich and von Imhof voted against it. Therefore, Amendment 1 failed by a 2:2 vote. CHAIR WILSON announced that hearing no further amendments, he would entertain a motion to move SB 32 out of committee. 2:21:53 PM SENATOR VON IMHOF moved to report SB 32, [30-LD0188\J], from committee with individual recommendations and attached fiscal note(s) 2:22:03 PM CHAIR WILSON announced that without objection, SB 32 moved from Senate Health and Social Services Standing Committee. 2:22:12 PM SENATOR GIESSEL commented as follows: Before we leave this subject, you know there's a reason that Senator von Imhof is on the finance committee. She has expertise in that area. There's a reason that I am on the health committee. I'm a clinician. I appreciate the discussion today, thank you. 2:22:32 PM At ease. 2:23:58 PM CHAIR WILSON called the committee back to order. 2:24:17 PM There being no further business to come before the committee, Chair Wilson adjourned the Senate Health and Social Services Committee at 2:24 p.m.