ALASKA STATE LEGISLATURE  HOUSE HEALTH AND SOCIAL SERVICES STANDING COMMITTEE  March 4, 2014 3:04 p.m. MEMBERS PRESENT Representative Pete Higgins, Chair Representative Wes Keller, Vice Chair Representative Lance Pruitt Representative Lora Reinbold Representative Paul Seaton Representative Geran Tarr MEMBERS ABSENT  Representative Benjamin Nageak COMMITTEE CALENDAR  HOUSE BILL NO. 301 "An Act relating to duties and procedures of the state medical examiner and the Department of Health and Social Services; and relating to death certificates." - HEARD & HELD HOUSE BILL NO. 324 "An Act relating to the controlled substance prescription database." - HEARD & HELD PREVIOUS COMMITTEE ACTION  BILL: HB 301 SHORT TITLE: AUTOPSIES AND DEATH CERTIFICATES SPONSOR(s): REPRESENTATIVE(s) HERRON 02/07/14 (H) READ THE FIRST TIME - REFERRALS 02/07/14 (H) HSS 02/20/14 (H) HSS AT 3:00 PM CAPITOL 106 02/20/14 (H) Heard & Held 02/20/14 (H) MINUTE(HSS) 03/04/14 (H) HSS AT 3:00 PM CAPITOL 106 BILL: HB 324 SHORT TITLE: CONTROLLED SUBST. PRESCRIPTION DATABASE SPONSOR(s): REPRESENTATIVE(s) KELLER 02/21/14 (H) READ THE FIRST TIME - REFERRALS 02/21/14 (H) HSS, FIN 03/04/14 (H) HSS AT 3:00 PM CAPITOL 106 WITNESS REGISTER LIZ CLEMENT, Staff Representative Bob Herron Alaska State Legislature POSITION STATEMENT: Introduced the committee substitute (CS) for HB 301 for the sponsor, Representative Herron. RAEBELLE WHITCOMB, Director Workforce Development Center Bristol Bay Native Corporation Dillingham, Alaska POSITION STATEMENT: Testified during discussion of HB 301. MARCIA DAVIS, General Council Senior Vice President Calista Corporation Anchorage, Alaska POSITION STATEMENT: Testified during discussion of HB 301. KERRE SHELTON, Director Central Office Division of Public Health Department of Health and Social Services Anchorage, Alaska POSITION STATEMENT: Testified during discussion of HB 301. JIM POUND, Staff Representative Wes Keller Alaska State Legislature Juneau, Alaska POSITION STATEMENT: Introduced HB 324 for the sponsor, Representative Keller. DON HABEGER, Director Division of Corporations, Business, and Professional Licensing Department of Commerce, Community & Economic Development (DCCED) Juneau, Alaska POSITION STATEMENT: Testified and answered questions during discussion of HB 324. DIRK WHITE, Chairman Board of Pharmacy Sitka, Alaska POSITION STATEMENT: Answered questions during discussion of HB 324. BARRY CHRISTENSEN, Pharmacist Co-Chair Legislative Committee Alaska Pharmacists Association Ketchikan, Alaska POSITION STATEMENT: Testified during discussion of HB 324. JOHN ZIPPERER, MD Zipperer Medical Group Wasilla, Alaska POSITION STATEMENT: Testified and answered questions in support of HB 324. RICHARD HOLM, Pharmacist North Pole, Alaska POSITION STATEMENT: Testified during discussion of HB 324. PATRICIA SENNER Alaska Nurses Association Anchorage, Alaska POSITION STATEMENT: Testified and answered questions during discussion of HB 324. ACTION NARRATIVE 3:04:00 PM CHAIR PETE HIGGINS called the House Health and Social Services Standing Committee meeting to order at 3:04 p.m. Representatives Higgins, Keller, Tarr, Seaton, and Reinbold were present at the call to order. Representative Pruitt arrived as the meeting was in progress. HB 301-AUTOPSIES AND DEATH CERTIFICATES  3:04:56 PM CHAIR HIGGINS announced that the first order of business would be HOUSE BILL NO. 301, "An Act relating to duties and procedures of the state medical examiner and the Department of Health and Social Services; and relating to death certificates." REPRESENTATIVE KELLER moved to adopt the proposed committee substitute (CS) for HB 301, labeled 28-LS1196\P, Mischel, 2/27/14, as the working draft. There being no objection, it was so ordered. 3:05:43 PM LIZ CLEMENT, Staff, Representative Bob Herron, explained that the changes in Version P were mostly the result from questions raised by the committee and the Department of Health and Social Services. The first change was on page 2, line 3, paragraph (3), which removed from statute explicit reference for the state's responsibility to cover the cost of any embalming that transport carriers could require for the transport of human remains. She declared that this would allow the department to "stand strong with the families with which they work and find ways around the families being required to pay that additional cost" should the transport companies require embalming for transport. She directed attention to page 2, lines 28-29, a change of language to read "transportation to the community closest to where the death occurred or to another location," which now clarified both of these options in the written notice from DHSS to the family. She moved on to page 3, lines 2-3, which deleted the requirements for temperature controls, and limited the temperature control practice to those available for maintaining remains shipped by air. The requirement would no longer be in statute. She stated that Sections 3 and 4 from the original bill had been deleted, and that Sections 5 and 6 in the original bill were now renumbered as Sections 3 and 4. 3:11:24 PM RAEBELLE WHITCOMB, Director, Workforce Development Center, Bristol Bay Native Corporation, expressed her support for the proposed changes in Version P, and, regarding the requirement for embalming prior to transport, she declared that transportation carriers should not have the right of determination regarding the deceased over the rights of the family. She asked about the process for the issuance of the death certificate, asking for clarification that local health aides in a community could begin the process. She expressed appreciation for the proposed bill as it recognized "many factors that are a concern for both Bristol Bay Native Association and families." She pointed out that the costs associated with a death were still very high, and she noted that there were still concerns for funeral homes controlling the remains of the deceased until the family had the funds for release of the body. MARCIA DAVIS, General Council, Senior Vice President, Calista Corporation, echoed the sentiments of Ms. Whitcomb for the obligations of air transporters. She asked that it be clarified that, as the bodies were removed by the state, it was necessary for the bodies to be returned by the state, and it was incumbent for the state to deal with the air transporter. She expressed her confidence with the compassion of the Medical Examiner's office for not allowing a body to sit "in purgatory" while waiting for solutions. She stated the necessity for understanding that "the state takes the body, the state needs to return the body." Referring to the issuance of death certificates by local authorities, she reported that the system had worked well with birth certificates and that the systems were in place for death certificates. She noted that the Bureau of Vital Statistics was in support of the proposed program. REPRESENTATIVE SEATON, noting that the language on page 2, line 3 had been changing, asked that Ms. Davis contact the local air carriers to ensure they know that embalming was not required by law. MS. DAVIS said that this information would go out on the web pages, and that she would meet with the air carriers. 3:19:42 PM KERRE SHELTON, Director, Central Office, Division of Public Health, Department of Health and Social Services, pointed out that there was only one medical examiner in Alaska, located in Anchorage. As there were not enough cases for a second position, all bodies requiring an autopsy were transported to Anchorage, inspected, and then returned to the community. She stated that standard practice was for the return transport to any location the family requested, and that the family would pay any additional cost. She clarified that embalming was not required by law or by the air transfers, although there had been confusion regarding its requirement. She said that there was some temperature control for bodies, including freezing when necessary, although this was not done for all bodies. She shared that there had been discussions for a pilot project to study the feasibility of rural examinations via telemedicine, although there was still a lot of equipment, infrastructure, and training to be determined. She acknowledged the zero fiscal note for the proposed bill [Included in members' packets] and stated that the costs would be borne by the local jurisdictions. She explained that the electronic vital records system would soon distribute death certificates, which would greatly reduce the time delay for completion. 3:25:59 PM CHAIR HIGGINS closed public testimony. 3:26:20 PM The committee took a brief at-ease. 3:27:21 PM REPRESENTATIVE SEATON pointed to a large study by the United States military regarding suicides, as this was an issue in rural Alaska. He reported that a low Vitamin D level resulted in twice the at-risk for suicide. 3:29:01 PM CHAIR HIGGINS said that HB 301 would be held over. 3:29:15 PM The committee took an at-ease from 3:29 p.m. to 3:31 p.m. HB 324-CONTROLLED SUBST. PRESCRIPTION DATABASE  3:31:07 PM CHAIR HIGGINS announced that the next order of business would be HOUSE BILL NO. 324, "An Act relating to the controlled substance prescription database." REPRESENTATIVE KELLER, as the bill sponsor, said that this was not an attempt to state that there was an opiate abuse problem in Alaska. He explained that the policy in question was whether this data base was important enough to maintain, and, if so, how to pay for the data base. He pointed out that there were not general funds to continue payment for the existing data base. 3:32:45 PM JIM POUND, Staff, Representative Wes Keller, Alaska State Legislature, introduced the proposed bill, stating that it would continue a service to help slow "the illicit, illegal opiate trade business in Alaska," and that these prescription opiates are a leading cause of overdoses and drug related deaths in the country. He noted that these are not considered to be "the normal drug culture type deaths." He reported that the federal government had provided funding for a limited time to start an opiate database in Alaska, but there was no longer any funding in the state's Fiscal Year 2015 budget to continue operation. He stated that the proposed bill would continue this database for opiate prescription drugs, with operation and funding being overseen by the Board of Pharmacy. He declared this to be a crucial part in "slowing the ongoing opiate problem in the State of Alaska." He reported that shoppers would go from doctor to doctor for prescriptions, and then go from pharmacy to pharmacy to have the prescription filled. He said the database would act as a deterrent to this action. Directing attention to the attached fiscal note for $57,000 [Included in members' packets], he estimated that a full scale operation for the database would cost about $150,000. 3:35:08 PM REPRESENTATIVE REINBOLD stated her belief that the program was absolutely critical, and she asked for clarification regarding the fiscal note. MR. POUND offered his belief that the fiscal note would pay for the basic annual operation. REPRESENTATIVE KELLER said that the Department of Health and Social Services (DHSS) was available to speak to the fiscal note. REPRESENTATIVE REINBOLD stated that the data base was critical as "these people are pretty darn sneaky." REPRESENTATIVE KELLER referred to an amendment that he had not yet proposed, which would change the wording on page 4, line 29, deleting "provider" and inserting "practitioner." MR. POUND explained that providers "are the ones who actually provide the drugs" which is limited to the pharmacist in most cases, whereas practitioner included everyone who had access to the database. REPRESENTATIVE SEATON expressed concern that the data base was only for immediate input and was not immediately searchable. He surmised that the purpose of the data base was to stop multiple prescriptions, which would require an interactive database. MR. POUND suggested that there would be an input page on the computer in the pharmacy and a staffer would put your personal information into the computer and the database. He compared the technology to that of a search for the availability of a vanity license plate. He clarified that the privacy information would only be available to practitioners and pharmacists. REPRESENTATIVE SEATON offered an anecdotal situation regarding the usefulness of the data base. MR. POUND replied that he projected the data base would have an immediate response for any problems. He allowed that it was debatable whether the pharmacist had the authority to not fill a prescription which had been written by a doctor. REPRESENTATIVE TARR asked for a comparison of the proposed and the existing prescription drug databases. She asked if this proposed bill would continue the funding for the current database. REPRESENTATIVE KELLER replied that his understanding was that the current data base was not real time, whereas the goal was to have a real time database. MR. POUND added that, as technology was quickly changing, the proposed bill allowed the department more flexibility. REPRESENTATIVE TARR suggested that this could be a seamless transition from one database to the next. 3:44:00 PM DON HABEGER, Director, Division of Corporations, Business, and Professional Licensing, Department of Commerce, Community & Economic Development (DCCED), in response to Chair Higgins, said that real time was subjective, and that, by regulation, the pharmacist in charge must report dispensed controlled substances every thirty days and this information was uploaded into a data base run by a third party vendor. This data was available for immediate use, and could be reviewed for previous prescriptions to a patient. He suggested that some of the larger pharmacies may input on a daily basis. CHAIR HIGGINS asked if this data base was being shut down due to lack of funding. MR. HABEGER replied that the database had been built using a $400,000 grant from the US Department of Justice, with an annual operating cost of $100,000. He relayed that, although that funding had stopped in the previous year, DCCED and Department of Health and Social Services had combined funding to temporarily maintain the program through this year. CHAIR HIGGINS asked if proposed HB 324 was trying to improve the same database. MR. HABEGER explained that the database existed and was operational; however, there was not any future funding and any improvements as determined by the proposed bill would also be necessary. CHAIR HIGGINS asked if the cost for proposed improvements was reflected in the fiscal note. MR. HABEGER replied that there would be a new fiscal note. He explained that there was already existing Board of Pharmacy designated staff, paid through receipt supported services, in the investigative section. He offered his belief that the updated fiscal note would be for $105,000, which would include the existing program and staff. CHAIR HIGGINS declared that his use of the database had been favorable, that it "is a very good commodity that the state has and I would hate to see it go away because we're not giving it money that it should have." He had concern for the lack of real time, and he asked for the cost to make the database in real time. He asked what would be the "reasonable fee" from the prescribers to maintain the data base. He said "we should do this." MR. HABEGER said that he could not guess at the reasonable cost. He expressed concern for the cause and effect of the licensing statute, as it stated that non-payment would result in forfeiture of the license. Directing attention to Section 7 of the proposed bill, he asked if there should be an enforcement action if the fee was not paid. 3:52:55 PM REPRESENTATIVE TARR asked if any of these services would bill Medicaid, and if there was any other health care database to integrate with this database. MR. HABEGER said that there were concerns with the original bill for security and patient confidentiality. He did not know the reason for contracting with a third party vendor. REPRESENTATIVE SEATON asked if there were any pharmacies that did not have access to this technology, and if so, was there an exemption if they were not able to comply. MR. HABEGER explained that the pharmacist had to first access a web page, then sign in, and type in the information. He opined that larger establishments could download into the database, and that the use of an electronic system added clarity. He surmised that no one was using a paper format. REPRESENTATIVE SEATON asked if hospitals and clinics were included in this requirement to use the database. MR. HABEGER replied that he was not certain and he deferred to the Board of Pharmacy. REPRESENTATIVE SEATON, in response to Chair Higgins, directed attention to page 3, line 9, "other than those administered to a patient at a health care facility," which possibly relieved the other facilities of the responsibility for use of the database. He declared that he would like clarification of what was covered. MR. HABEGER again deferred to the Board of Pharmacy. REPRESENTATIVE TARR, noting that other user groups paid licensing fees which were typically used for training, enforcement, and certifications, asked if it seemed unusual that this fee was paid by the subscribers for the service, even though it was a service to the patients. MR. HABEGER replied that this was an anomaly, as the normal licensing fees for this structure were included in Title 8, and this proposed bill inserted the Board of Pharmacy's necessity to collect the fees into Title 17. He stated that this would not be under the auspices of his division. CHAIR HIGGINS asked how many prescribing doctors were licensed in Alaska. MR. HABEGER replied that there were about 5,500. CHAIR HIGGINS asked what would be a reasonable fee if it was only paid by these licensed physicians. MR. HABEGER said that the fee would be expanded to include all the prescribers in Alaska, including nurse practitioners, among others. He said the Board of Pharmacy would make that decision, and he offered an assumption that the fee would be divided equally. REPRESENTATIVE SEATON asked if the fiscal note [Included in members' packets] was being revised. MR. HABEGER replied that a new fiscal note would change the language to include the new license program. 4:02:18 PM DIRK WHITE, Chairman, Board of Pharmacy, stated that there had originally been intent language that pharmacists would not be charged to maintain this program, and the pharmacists would prefer to maintain that original intent and find another means to fund this program. He said that pharmacists were already under a financial burden to input the data. CHAIR HIGGINS pointed to page 4, lines 27-29, and asked if the Board of Pharmacy disagreed with the language. MR. WHITE replied that pharmacists already incurred a financial burden with having to gather and provide the data. He agreed that the Board of Pharmacy would prefer this language was not included in the proposed bill, as it was not the intent of the original legislation for the pharmacists to bear the financial burden to maintain the program. REPRESENTATIVE KELLER relayed that the intent was "not to pick on anybody." He opined that the House Health and Social Services Standing Committee would do its best, and would forward it to the House Finance Committee. He declared that "it was not the intent, it's just that somebody's gotta pay." REPRESENTATIVE REINBOLD suggested that Mr. White contact the Administrative Regulation Review committee, of which she was the chair. REPRESENTATIVE SEATON directed attention to the aforementioned consequence, and asked if the Board of Pharmacy had the authority to adopt consequences if the fees were not paid. MR. WHITE deferred to Mr. Habeger. REPRESENTATIVE SEATON suggested a need for clarity to this, before the proposed bill moved. MR. WHITE offered to research the question. 4:08:25 PM BARRY CHRISTENSEN, Pharmacist, Co-Chair, Legislative Committee, Alaska Pharmacists Association, stated that the Alaska Pharmacists Association represented pharmacists and pharmacy technicians in Alaska. He declared that this proposed bill was important to the membership. He relayed that the original intent of the program was for it to be voluntary for the pharmacist to access, as it was necessary to use professional judgment to determine whether to access the data base. He pointed out that pharmacists often did not immediately enter the data for each prescription, and that logistical and technical reasons had prevented the program from being real time. He directed attention to page 2, line 31, [paragraph] (3), which stated "in cooperation with the board, seek funding sources other than the state for operation of the controlled substance prescription database," and he asked for further clarification. Moving on to page 4, line 19, he questioned the delegation of authority to access the database, expressing concern for unlicensed people, outside a pharmacy, being able to access this database. MR. CHRISTENSEN, in response to Representative Keller, suggested that page 4, line 21, be changed to say "licensed employee," which would allow greater control over access to the database. REPRESENTATIVE SEATON asked for clarification that it would be an employee, and not specifically a "practitioner." He asked if all the practitioners with access to the database would be licensed. MR. CHRISTENSEN replied that all the practitioners would be licensed. REPRESENTATIVE TARR asked how the database funding was being addressed in other states. MR. CHRISTENSEN replied that there were other funding mechanisms, which included payment by all the prescribers in Oregon, Medicaid settlements, private donation foundations, and state general revenue funds. He asked about the cost for collection and administration of the funds. 4:16:15 PM CHAIR HIGGINS, noting the difficulty to forge computer generated script [prescriptions], asked whether there were more hand written or computer generated prescriptions. MR. CHRISTENSEN replied that there were more computer generated prescriptions, and that the number of forgeries had dropped significantly. He declared that although there was still a problem with people shopping from office to office, the database program had helped to control this practice. REPRESENTATIVE SEATON directed attention to page 3, line 28, and he asked if there was any conflict with maintaining the database in a secure file and the requirement on page 4, line 13, which stated that the database should be purged after two years. MR. CHRISTENSEN said that federal law, mirrored by state law, required the two year controlled substance prescription data purge, and he did not see any conflict. REPRESENTATIVE SEATON asked for clarification for what portion of the data base was purged. MR. CHRISTENSEN said that the identifications and the prescriptions were purged. CHAIR HIGGINS asked if the information was purged every two years for storage reasons. MR. CHRISTENSEN offered his belief that this practice mirrored federal regulations for how long a prescription needed to be kept on file by a pharmacy. He clarified that the records were actually kept by the pharmacies for ten years for Medicare regulations. He opined that the cost for data storage and maintenance could be the reason for the purge. He suggested that people who were shopping for drugs were doing this continually, and did not stop for a few years, and then start again. CHAIR HIGGINS noted that he was supposed to keep records for seven years. REPRESENTATIVE SEATON expressed his concern for page 4, line 13, which said "shall be purged from the database," as he did not want there to be conflicting requirements under the law. 4:22:40 PM JOHN ZIPPERER, MD, Zipperer Medical Group, stated his support for HB 324, noting that it was an important step forward, although it could go even further. He said that the most essential component was the ability for providers to access this information, and that these databases have "done tremendous good in preventing diversion of these substances." He offered several anecdotes regarding patients seeking prescriptions and the use of the prescription database. He stressed that the database was for the benefit of the patient, and access to it was critical for physicians. He concurred that the practitioners should be charged a fee for use of the database. He relayed a recommendation that a prescription drug monitoring report should be made on every patient on every visit. REPRESENTATIVE TARR asked if he was willing to pay a reasonable fee to maintain the database, and if so, what would he suggest for that fee. DR. ZIPPERER said that a subscription service to the providers for $40 to $50 each month would not be burdensome. He declared that the price for not using the database was a lot higher, and he suggested the opportunity for a physician to opt out of the service if not they did not prescribe these controlled substances. He declared that the database was "extremely valuable to the patients and to the citizens of Alaska." 4:28:55 PM RICHARD HOLM, Pharmacist, reported that he was the immediate past chair of the Board of Pharmacy. He suggested that it was necessary for the practitioner to have the opportunity to delegate staff to look up this information. He pointed out that HIPAA regulations necessitated that all pharmacy staff be licensed and regulated by the Board of Pharmacy, and he suggested a change to the wording of the proposed bill as previously mentioned by Mr. Christensen. He stated that many individuals benefited from this program, including pharmacists and prescribers, as well as system benefits to the patients and different agencies of the state. Because of this widespread benefit, he suggested use of the general fund to pay for the program. He reminded the committee that a fee on the prescribers was not fair, as not all prescribers dispensed these substances. He pointed out that the cost for maintaining the system was already paid by the pharmacists, although they were not mandated to use the system. He reported that there was still some paper reporting in the system from small dispensers, veterinarians, and dentists. He noted that the system also covered out of state pharmacies licensed in Alaska, although some would request exemptions as they did not send any controlled substances into Alaska. He suggested that it would be difficult to pinpoint the exact users of the system. REPRESENTATIVE REINBOLD asked for clarification regarding mail order pharmacies. MR. HOLM said that some out of state licensed pharmacies did not send controlled substances to Alaska. He discussed the difficulties for real time as it depended on the definition, and he offered some scenarios regarding distribution of prescriptions, declaring that, until a prescription was picked up by the patient, it was not truly dispensed. He stated that the database was developed for informational purposes, and he offered his belief that real time made it an enforcement tool. 4:40:11 PM PATRICIA SENNER, Alaska Nurses Association, reported that the Alaska Nurses Association had testified in support of creation of this data base in 2008, while expressing concern for the necessary safeguards for privacy. At that time, the association had requested that only licensed providers be allowed to access the database, and that personal addresses not be included in the database, which was not approved at that time. She expressed concern for the release of personal information. She reported that nurse practitioners required authority from the Board of Nursing to prescribe controlled substances, and, as these were prescribed on an intermittent basis, the fees should reflect the actual use of the database. She said that a small amount could be included in licensing fees, with the various boards having an enforcement role. REPRESENTATIVE TARR asked about any other cautionary issues to consider. MS. SENNER replied that there was the threat of blackmail using the database information, with the threat to release medical records. 4:44:02 PM CHAIR HIGGINS said that the bill would be held over, as the sponsor wanted to continue work on the bill. He suggested an opt out clause, or a monthly fee to access the database, so that only those who needed to use it would pay for it. He declared a need for more discussion regarding who could access the database. He declared his support for the database, and that general funds would be the best route to pay for it. He expressed understanding for the pharmacists' reluctance to pay for the database, as they already had to input the data and maintain it. CHAIR HIGGINS kept public testimony open. REPRESENTATIVE SEATON, in response to Representative Keller, said that he wanted more clarity for page 3, line 9, as to what was included as "administered to a patient at a health care facility." He opined that Section 3 was an opt in scenario, because if you were not distributing any of the listed controlled substances, you were not required to submit. He suggested that this could be the mechanism to define those who would opt-out, and not be required to pay a fee. CHAIR HIGGINS said that dentists were included in these schedules for the controlled substances, and that it covered a lot of people. He stated that not everyone would use the database, if there was not a need, as they did not prescribe the controlled substances. He suggested writing opt-out language. REPRESENTATIVE SEATON asked for clarification regarding the purges from the database after two years, and if there was any conflict with the maintenance of these records for ten years. CHAIR HIGGINS shared that he kept his patient records and copies of prescriptions for more than seven years. He said that he did not know how important it was for the two year purge. REPRESENTATIVE TARR asked for clarification for the necessary speed for recording the information and the definition of real time. REPRESENTATIVE SEATON pointed out that, as there were still written prescriptions, it might be necessary to include a provision regarding limited prescriptions and rural areas. CHAIR HIGGINS clarified that it was pharmacists who input the data, not those who write the prescriptions. REPRESENTATIVE SEATON replied that he was referring to earlier testimony for dispensing by rural doctors and veterinarians. 4:51:59 PM [HB 324 was held over.] 4:52:05 PM ADJOURNMENT  There being no further business before the committee, the House Health and Social Services Standing Committee meeting was adjourned at 4:52 p.m.