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2016 GAAC Suggested Legislative Positions and Priorities Proposal: To Approve the CSHP Positions and Priorities Recommended by Government Affairs Advisory Committee (GAAC) for Selected 2016 California Legislation. Submitted by: Jason Bandy, Board Liaison, GAAC and Keith Yoshizuka, Chair, GAAC Date: April 1, 2016 SITUATION 1. GAAC leadership and CSHP Staff reviewed 34 bills on March 1, 2016. 2. GAAC met via teleconference and WebEx on February 5, 2016, February 26, 2016, in person on March 11, 2016, and subsequently in a joint meeting with CPhA in March 26, 2016. 3. After committee discussion on February 26, 2016, 47 bills and proposed regulations were assigned to GAAC members for analysis. 4. At the March 11, 2016 meeting, GAAC members at CSHP Office and presented analysis reports for each bill. Each bill was reviewed and assigned a recommended position and priority. Subsequently, GAAC members met jointly with CPhA on March 26, 2016 to further discuss the bills and subsequently, some positions were revised. 5. A summary of the analysis and recommended positions/priorities is summarized in the table below with the actual analysis as an attachment. 6. CSHP and GAAC have a finite amount of resources (including time) available for legislative advocacy. 7. The definitions for CSHP legislative positions are: Sponsor/Co-Sponsor: Means CSHP shares responsibility with the bill author(s) and/or other cosponsor(s) to assist with the enactment of legislation. All sponsor/co-sponsor bills are Priority Level 1. Support: Means CSHP is fully satisfied with the provision in the bill as drafted, and wants the bill enacted. Oppose: Means CSHP does not support the bill, and there are no amendments that would remove CSHP’s opposition to the bill. A position of “oppose” shall only be assigned to bills with a Priority Level of 1 or 2. Disapprove: Page 1 of 48 8. 9. 10. 11. Means that CSHP does not support a bill – but has assigned a Level 3 Priority to it. In other words, CSHP does not like the bill, but will not expend resources to oppose it. Oppose Unless Amended: Means CSHP does not support the bill, but would remove opposition if specific amendments are made in the bill’s provisions. The specific amendments desired need to be described. If such amendments are made, CSHP’s position would then be modified to a “support” or “watch” position. Support If Amended: Similar to “Oppose Unless Amended,” means CSHP would support a bill if specific amendments are made in the bill’s provisions. The specific amendments desired need to be described. If such amendments are made, CSHP’s position would then be modified to a “support” position. Watch: Means CSHP declines to take a position on a bill at this time, and will wait for future amendments or a later time to take a position. GAAC will continue to watch, follow the bill and keep the CSHP Board of Directors apprised of the bill’s movement through the Legislature. The following priorities are used in establishing resource allocations for CSHP’s legislative positions: Priority 1: (Applies only to the following positions: Sponsor/Co-Sponsor, Support, Support if Amended, Oppose, and Oppose Unless Amended) Legislative Advocate actively works the bills. CSHP sends position letters to all legislators. Testimony is provided at hearings. Regional Chapters are asked to arrange visits to district offices of legislators. CSHP members are asked to write letters to their legislators. Priority 2: (Applies only to the following positions: Support, Support if Amended, Oppose, and Oppose Unless Amended) Legislative Advocate actively works the bills. CSHP sends position letters to all authors and legislators on key committees. Testimony is provided at hearings as time permits. Selected CSHP members are asked to write letters to their legislators. Priority 3: (Applies only to the following positions: Support, Disapprove, and Watch) If CSHP takes a position of support, position letters are sent to all authors and CSHP members are not asked to write letters to their legislators. No action will be taken on bills with disapprove or watch positions. In late 2010, a board working group was formed to redefine GAAC’s operational plan responsibilities. As part of that review, the board agreed that the GAAC should track fewer bills (around 10-15 bills). Historically, the GAAC has taken watch/level 3 position on all spot bills and assigned members to track them. These spot bills have been included in prior years tracked bill tallies. In the past, the CSHP GAAC has “tracked” bills according to the following priority. I do not have data for the past five years. Page 2 of 48 ‘00 ‘01 ‘02 ‘03 ‘04 ‘05 ‘06 ‘07 ‘08 ‘09 0 1 1 2 0 1 0 0 1 3 7 9 9 6 3 1 4 29 30 28 21 35 15 20 32 38 38 32 41 19 21 Priority 1 Bills: Priority 2 Bills: Priority 3 Bills: Total Bills 12. 1 ‘10 1 ‘11 1 5 0 2 2 24 20 23 34 13 29 26 24 37 15 Based on the GAAC’s recommendations, CSHP would track the following number of priority bills: Priority 1 Bills: 4 Priority 2 Bills: 1 Priority 3 Bills: 39 (including regulations) Total # Bills: 43 TARGET 1. Analyze pending legislation and regulations that impact the practice of pharmacy, taking action as needed. (Goal 2) 2. Monitor a reasonable number of pending legislation and regulations (for example 10-15 bills annually). (Goal 2) PROPOSAL 1. To approve the CSHP positions and priorities recommended by GAAC for selected 2016 California legislation: Bill # AB26* AB1696 Author JonesSawyer, (coauthor) Bonilla Kevin Mullin Marie Waldron Kristin Olsen & Adam Gray Evan Low Ian Calderaon Chris Holden AB1774 AB1823 Susan Bonilla Susan Bonilla AB45* AB73* AB507 AB1386 AB1668 Description Medical cannabis Position do not follow Priority Comments 3 Household hazardous waste HIV/AID treatment (formerly spot bill) BreEZe system, annual report watch support 3 3 watch 3 EPI auto-injectors Investigational drugs, biologicals, devices MediCal tobacco cessation services Clinical labs, licensure Cancer clinical trials watch oppose 3 3 support 3 watch watch 3 3 Page 3 of 48 AB1831 Evan Low AB1977 SB992 SB994 Jim Wood and Waldorn Jim Wood & Jeff Stone Freddie Rodriguez Adrian Nazarian Roger Hernandez Jim Cooper Mike Gatto S Eggman & Sen L Wolk Pat Bates Ed Hernandez Joel Anderson J. Fuller Jerry Hill SB999 Fran Pavley SB1174 Mike McGuire, Jim Beall, Loni Hancock, Carol Liu, Holly Mitchell Jerry Hill Jeff Stone AB2084 AB2144 AB2400 AB2436 AB2592 AB2638 AB2810 SB423 SB323 SB952 SB1193 SB 1217 SB1220 SB1229 SB1230 Mike McGuire Jackson and Stone Jeff Stone Healthcare coverage, prescriptions, refills Health coverage, abuse deterent opioid analgesics MediCal-comprehensive med management Pharmacy, prescriptions (spot bill) Drug coverage, prior auth support 3 watch 3 support 1 watch 3 watch 3 Health care coverage; drug pricing disclosures Prescriptions (spot bill) Vaccines Aid-in-dying prescription drugs disapprove 3 watch watch watch 3 3 3 OTC surplus; reuse Nurse Practitioners watch watch 3 3 Pharmacy technicians, licensing watch 3 Pharmacy practice (spot bill) Outpatient Health facilities; antimicrobial stewardship Health insurance; contraceptives, annual supply MediCal, children, prescribing patterns watch watch 3 3 watch 3 watch 3 BOP sunset provision extension DCA reporting of damage awards requirements Foster care, psychotropic drugs support support 3 3 watch 3 Pharmacies, secure takeback bins Pharmacies, compounding support 3 watch 3 Page 4 of 48 SB1335 SB1346 Holly Mitchell Ben Allen SB1454 SCR109 Jeff Stone Jeff Stone HR592 Pharmacists, Medicare Part B support 1 Pharmacists, Medicare Part B support 1 CCR1776 CCR1730 et al Brett Guthrie, G. K. Butterfield, & Todd C. Young Robert P. Casey, Mark Kirk, & Sherrod Brown BOP BOP Prescription Drug take Back Advanced Practice Pharmacists; Certifications watch watch 3 3 CCR1732 CCR1707.5 CCR1715.65 BOP BOP BOP Board Accredited CE Patient Centered Labels Reconcilliation & Inventory of Controlled Substances watch watch oppose unless amended 3 3 2 CCR1746.5 CCR1744 CCR1760 BOP BOP BOP Travel meds Drug Warnings Disciplinary Guidelines watch watch Do not follow 3 3 3 CCR1746.4 BOP Vaccinations S314 MediCal benefits, FQHC, RHC, mental health Drug labeling, med guides, electronic delivery Pharmacy (spot bill) California Pharmacists Outreach Week watch 3 support 3 watch support if amended 3 1 request author to amend to make California Pharmacist Outreach Week 3rd week of February EVERY year, become cosponsor if amended already submitted to Office of Administrative Law for review regulation is designed for retail pharmacies. Does not account for complexities of hospitals 3 Page 5 of 48 CCR1746.1 BOP CCRXXX BOP CCR1715&1784 BOP Self-Administered Hormonal Contraception Compounded Drugs Self-Assessment Form Revisions watch 3 watch watch 3 3 *Bills followed by GAAC since 2015 2. Because of a lower number of bills introduced affecting pharmacy this year, we are able to monitor some of the proposed regulations proposed by the Board of Pharmacy this year. Bill Analysis Reports and Fact Sheets (in numerical order) CSHP BOARD ACTION: At its April 14-15, 2016 meeting, the board voted and approved on the proposals. Page 6 of 48 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: AB 26 Author: Jones-Sawyer, (co-author) Bonilla Sponsor: Council (UFCW) United Food and Commercial Workers Union, Western States Date Bill Entered: Date formally introduced 12/1/2014_Original 1/26/2014 Amendment Medical cannabis Subject: Digest: Requires a licensee under the Medical Marijuana Regulation and Safety Act (MMRSA) to institute and maintain a training program to educate, inform, and train the licensee's agents and employees regarding compliance with the MMRSA. Requires the Bureau of Medical Marijuana Regulation (Bureau) to adopt standards for the approval of training programs and to be the sole state agency responsible for approving and regulating the training programs. Analysis: • As written, this bill does not directly nor indirectly affect health systems, pharmacists or pharmacies. • Its key purpose is to ensure all persons working under MMRSA are adequately trained, and that the Bureau establish and approve all training programs for employees of entities covered under MMRSA • Labor is an interested party in ensuring that their members are sufficiently aware of all MMRSA requirements Contact: pending) Charles Harvey (Sacramento office) – emailed 3/3/16 (response [email protected] Position: States Council SupportUnited Food and Commercial Workers Union, Western Oppose None at this time. Recommended Position: Do Not Follow Recommended Priority: N/A Report Prepared by: Robert L. Stein, Pharm.D., J.D. Page 7 of 48 Date: Feb 29, 2016 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: AB 45 Author: Mullin, Kevin ; Democrat; Assembly Member; Speaker pro Tem Sponsor: none Date Bill Introduced: 12/1/2014 - Original 1/27/2016 – Last Amendment 4/30/2015 – Amendment 4/23/2015 – Amendment 4/13/2015 – Amendment 3/19/2015 – Amendment Subject: Household Hazardous Waste Collection Summary (Digest): The bill would require the department (Dept. of Resources Recycling and Recovery (DRRR)) to adopt model ordinances for a comprehensive program for the collection of household hazardous waste (HHW) and would authorize a local jurisdiction that provides for the residential collection and disposal of solid waste that proposes to enact an ordinance governing the collection and diversion of HHW to adopt one of the model ordinances adopted by the department. The bill would require the DRRR to determine whether a nonprofit organization has been created and funded to make grants to local jurisdictions for specified purposes relating to HHW disposal and would specify that if the DRRR does not determine that such a non-profit organization exists by 12/31/18, then the bill’s provisions would be repealed on 1/1/19. Analysis (Your thoughts about the bill): AB 45 included unused pharmaceuticals (OTC/Prescription) as a component of HHW. The mechanism for collecting this component is not detailed in the bill. However it may be worth watching to be aware if future amendments would detail pharmaceutical collection. Funding seems dependent on non-profit organizations creating and funding grants to local jurisdictions. Recommended Position (Support, Oppose, Watch): Watch CPhA – no mention Recommended Priority (1-3): Below a 3 Priority? Page 8 of 48 Bill Contact: Assembly Member Mullin’s District Office Tel: (650) 349-2200 Report Prepared by: Gene Borrelli RPh, MBA Date: 3/7/16 Page 9 of 48 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: AB 73 Author: Marie Waldron (R-Escondido) Sponsor: Marie Waldron (R-Escondido) Date Bill Introduced: Introduced 12/18/2014 Last Amended 1/5/16 Passed Assembly (77-0-2) on 1/25/2016 Subject: Patient Access to Prescribed Antiretroviral Drugs for HIV/AIDS treatment Act Summary (What does this bill do): This bill, to the extent permitted by federal law, would provide that if medically necessary antiretroviral drugs used in the treatment of HIV/AIDS is prescribed by a Medi-Cal beneficiary's treating provider for that purpose, and coverage for that prescribed drug is denied by a MediCal managed care plan in which the beneficiary is enrolled, that denial shall be reviewed in accordance with the bill. This bill would provide that if the treating provider demonstrates, consistent with federal law, that in his or her reasonable, professional judgment, the drug is medically necessary and consistent with the federal Food and Drug Administration's labeling and use rules and regulations, as specified, the beneficiary would be entitled to an automatic urgent appeal. An urgent appeal shall be resolved by the plan within 24 hours after the plan receives the request. Support: None (Previous Support: American Nurse Association\California, Biocom, California Chronic Care Coalition, California Healthcare Institute) Opposition: None (Previous Opposition: California Association of Health Plans, Health Access California) Analysis: Through the various amendments and alterations to the bill since its introduction, the scope of the legislation has been greatly diminished. The bill now solely addresses antiretroviral medications prescribed for HIV treatment and denied by Medi-Cal. The current appeal process is defined as lasting 72 hours and this bill, if passed, would shorten that appeal timeframe to 24 hours. While the shortening of the review period is important to a patient and his/her care and preventing treatment gaps would lessen the risk of resistance mutations, the impact of a quicker appeal process would have little impact on the day to day activity of the profession of pharmacy. Recommended Position (Support, Oppose, Watch): Support Recommended Priority (1-3): Priority 3 Bill Contact: Andrea Gutierrez (916) 319-2075 (Capital Office) Page 10 of 48 Report Prepared by: Chris Mapes Date: 3/8/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: AB 507 Author: Kristin Olsen & Adam Gray Sponsor: None Date Bill Entered: Date formally introduced 2/23/15 Original 3/26/15 Amendment Subject: Audit of implementation of Breeze System for licensing by the CA Dept of Consumer Affairs Digest: Requires the Department of Consumer Affairs to submit an annual report to the Legislature and the Department of Finance that includes the Department's plans for implementing the BreEZe system at specified regulatory entities included in the Department's 3rd phase of the implementation project, when available, including, a timeline for the implementation. Requires posting the name of each regulatory entity that is utilizing the system on the Department's Internet Web site. Analysis: Breeze system Phase I was implemented in 2013 for select entities Board of Pharmacy is set to be implemented in Phase 3 which is still to be determined Initial rollout has been way over budget and has resulted in numerous complaints from users of long delays An audit showed very little oversight and a poorly written contract with the vendor This bill simply asks for an implementation plan be submitted to the assembly to improve oversight and transparency Contact: Position: Oppose : Support Dept of Consumer Affairs None Page 11 of 48 Recommended Position: Watch Recommended Priority: 3 Report Prepared by: Thomas Pugh Date: 3/4/2016 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Report Bill Number: AB 1386 Author: Assemblymember Evan Low Sponsor: National Alliance for Hispanic Health, California Department of Public Health, American Latex Allergy Association, California Advocates for Food Allergies Date Bill Entered: Subject: 02/27/15 X Original 01/13/16 X Amendment Emergency Medical Care; Epinephrine Autoinjectors Digest: Defines entities authorized to use an epinephrine auto injector to render care for emergent situations according to provisions set forth in bill. Pharmacies are authorized to furnish epinephrine auto injectors to authorized entities. Establishes criteria for reporting adverse incidents regarding administration of these agents and relieves the burden of liability to entities for civil damages resulting from the act or omission of administration. Analysis: Existing legislation identifies a medical care person, first responder, and lay rescuer as authorized entities to administer epinephrine auto injectors to render emergent care. Current legislation authorizes a pharmacy to dispense epinephrine auto injectors to prehospital emergency staff, first responder, or lay rescuer for the purpose of rendering care. The bill refers to individuals who are permitted to use epinephrine auto injectors as “authorized entities,” to permit other individuals the use of auto injectors in the context of providing emergent care. The bill authorizes pharmacies to furnish epinephrine auto injectors to an authorized entity as part of a state mandated program. The bill would requires the authorized entity to maintain an operation plan in regards to the use and administration of the auto injectors and to submit a report to the California Department of Public Health regarding incidences related to its administrations. The bill would require CDPH to issue an annul report summarizing of reported incidences in accordance to the provisions set forth by the bill. California Pharmacists Association is reviewing the bill to determine its disposition. CDPH refers to the priority of this bill low, but has support of a senate bill, SB 738, which limits the liability of physicians of those who prescribe epinephrine injectors and mandates school Page 12 of 48 districts, charter schools, and county offices of education to provide and administer epinephrine auto injectors to those who are suffering from an anaphylactic reaction. Contact: Gina Frisby, [email protected] Position: Support Introduced, currently pending for CPhA support Oppose None listed Recommended Position: Watch Recommended Priority: Priority 3 Report Prepared by: Jasmine Reber Date: 03/04/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: AB 1668 Author: Ian Calderaon (D-Whittier) Sponsor: None Date Bill Entered: Date formally introduced 1/15/2016 Original Subject: Access to investigational drugs, biologics or devices for patients with lifethreatening conditions Digest: Permits a manufacturer of an investigational drug, biological product, or device to make the product available to eligible patients with life-threatening conditions. Authorizes a health benefit plan to provide coverage for any investigational drug, biological product, or device. Prohibits disciplinary action against any physician for a related recommendation. Prohibits using such recommendation as the basis for excluding a physician from Medicaid or Medicare certification. Analysis: “Right to Try” Bill Similar bill was vetoed by Governor last year Under current FDA law patients are prohibited from having access to investigational drugs unless approved by an special express approval, however there is often delay in the process which terminally ill patients cannot wait for. This law would bypass FDA regulation. May expose patients to unapproved and unregulated drugs Pharmacists may be caught in the middle providing drugs with little or known safety or therapeutic information Weakens the authority of the FDA to regulate drugs Page 13 of 48 Contact: Position: Support Consumer Groups Oppose CMA initially opposed, but has withdrawn after protections for providers was added CNA PharMA Oncologist groups Recommended Position: Oppose Recommended Priority: 3 Report Prepared by: Thomas Pugh Date: 3/4/2016 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Report Form Bill Number: AB 1696 Author: ASM Chris Holden (D) district 41 Sponsor: TBD Date Bill Entered: Subject: Date formally introduced 1/21/16 Tobacco Cessation Services Digest: This bill would provide that, only to the extent that federal financial participation is available and not otherwise jeopardized, and any necessary federal approvals have been obtained, tobacco cessation services are covered benefits, subject to utilization controls, under the Medi-Cal program and would require those services to include all intervention recommendations, as periodically updated, assigned a grade A or B by the United States Preventive Services Task Force, and, at a minimum, 4 quit attempts per year. The bill would also require, only to the extent consistent with the recommendations of the United States Preventive Services Task Force, tobacco cessation services to include at least 4 counseling sessions per quit attempt and a 12-week treatment regimen of any medication approved by the federal Food and Drug Administration for tobacco cessation. The bill would require the department to seek any federal approvals necessary to implement those provisions Page 14 of 48 Analysis: This bill would require that smoking cessation programs covered by MediCal be consistent with established federal standards Contact: Victor Munoz [email protected] Position: Support TBD Oppose TBD Recommended Position: Support Recommended Priority: 3 Report Prepared by: Keith Yoshizuka Date: 3/10/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: AB 1774 Author: Bonilla, Susan; Democrat; Assembly Member; Chair, Business & Professions Sponsor: none Date Bill Introduced: 02/18/2016 Original Subject: Clinical Laboratories: licensure Summary: This bill would repeal the laws requiring a clinical laboratory to be licensed and inspected by the department (SDPH), including the licensing fee. The bill would also make conforming changes. Analysis: This is a major overhaul of what seemed like a lot of duplicative regulations. The amended and repealed sections of the Business and Professions code (654.1 through 1325) do not impact or mention pharmacy. There are also amendments to the Food and Agricultural Code, the Health and Safety Code and the Welfare and Institutions Code that likewise do not impact pharmacy. Recommended Position (Support, Oppose, Watch): Watch Page 15 of 48 CPhA is also tracking Recommended Priority (1-3): Bill Contact: Assembly Member Bonilla’s Office Tel: 925-521-1511. Report Prepared by: Date: 3 Gene Borrelli RPh, MBA 3/8/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: AB 1823 Cancer Clinical Trials Program Author: Susan Bonilla Sponsor: Unknown Date Bill Introduced: 2/8/16 Subject: Creating the California Cancer Clinical Trial Program as part of the Health & Safety Code Summary (What does this bill do): The bill requires the University of California to establish a nonprofit organization or designate an existing one to fund the California Cancer Clinical Trial Program. The president of the university to will appoint at least 5 members from the university to govern the program without compensation. Once the non-profit organization collects at least $500,000 of donations from industry, research organizations, government agencies, individuals etc, the university shall be reimbursed for establishment and operating costs. Then the board can use the remaining donations as grants to research hospitals, non-profits, their own research and clinical trials, and patient education and community outreach to increase patient access to cancer clinical trials in underserved communities. Funds can also be used for patient or caregiver airfare, lodging, meals, childcare, etc. The university can be a beneficiary as well as decline to establish or participate in the program. If the program does not raise $500,000 by 1/1/21, the University of California will reimburse itself for establishment and operating costs and return the remaining donations to donors pro rata. Analysis (Your thoughts about the bill): While the bill has a good intention of increasing access to cancer clinical trials in underserved areas up to at least 1/1/21, it does not include parameters to hold the University of California to this intention. Page 16 of 48 The bill does not define the underserved population that it will be assisting. It is unclear what the operational cost for this program is and how much of the dentations will be used to benefit patients. This bill will, however, provide an opportunity for cancer patients to potentially benefit from care and resources provided by the program. Recommended Position (Support, Oppose, Watch): Watch Recommended Priority (1-3): 3 Bill Contact: [email protected]; (925) 521-1511 Report Prepared by: Ronika Kalpage Date: 3/9/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: AB 1831 Author: Evan Low (D-Los Gatos) Sponsor: Date Bill Entered: Subject: of use Date formally introduced 2/09/2016 Early refills of covered topical ophthalmic products at 70% of the predicted days Digest: Requires plans and insurers that provides coverage for prescription drugs benefits to allow for early refills of covered topical ophthalmic products at 70% of the predicted days of use. The bill would impose a state-mandated local program because a willful violation of the bill’s requirements by a health care service plan would be a crime. Analysis: Over 2/3 of patients have trouble administering a single drop of prescription eye medications according to the American Glaucoma Society. At least 21 days for 30-day supply, 42 days for 60-day supply and 63 for a 90-day supply Medicare guidelines allow for patients to obtain eye drop refills at 70% of the predicted use of days Page 17 of 48 This law would expand that provision to include all plans and insurers that provides coverage for prescription drugs benefits Pharmacists will be able to provide better customer service Contact: Position: Support Oppose: CA Association of Health Plans has a position of “Watch” at this time Recommended Position: Watch Recommended Priority: 3 Report Prepared by: Lily Zheng Date: 3/9/2016 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: AB 1977 Health Coverage, Abuse Deterrent Opioid Analgesics Author: Jim Wood and Waldorn Sponsor: Unknown Date Bill Introduced: 2/16/16 Subject: Allowing abuse deterrent opioid analgesics to be covered on formulary by health insurance companies as part of the Insurance Code and Health and Safety Code Summary (What does this bill do): The bill requires individual or group healthcare services or disability insurance policies issued, amended, or renewed after 1/1/16 which provide coverage for opioid analgesics to cover on formulary at least one abuse deterrent opioid analgesics per opioid analgesic active ingredient. The bill also prohibits requiring the patient to try a nonabuse-deterrent opioid analgesic before receiving coverage for the abuse deterrent opioid analgesic. The co-pay for brand name products should not exceed the lowest cost-sharing of the brand name product. Also, the bill will impose a state-mandated local program to make willful violation of the bill’s requirements a crime. Analysis (Your thoughts about the bill): Page 18 of 48 The bill addresses a solution to the need for safer distribution and use of opioid analgesics. The bill mandates that the cost of the abuse-deterrent opioid analgesic not be increased to greater than the lowest-cost sharing price. The bill allows patient to avoid the risk of addiction and abusing opioids by prohibiting requiring he/she to try a non-abuse-deterrent product first. The bill does not specify what tier the abuse deterrent opioid analgesics will be. The bill does not specify the funding and resources to be used to enforce this bill. Recommended Position (Support, Oppose, Watch): Support Recommended Priority (1-3): 3 Bill Contact: [email protected]; (707) 463-5770 Report Prepared by: Ronika Kalpage Date: 3/9/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: AB 2084 Author: Jim Wood (D-Eureka) and Jeff Stone Sponsor: CPhA Date Bill Entered: Subject: Date formally introduced 2/17/2016 Coverage of comprehensive medication management (CMM) under Medi-Cal Digest: CMM services be a covered benefit under Medi-Cal and require development and implementation of a written medication treatment plan to resolve medication therapy problems and to prevent future medication therapy problems. The department will evaluate the effectiveness of CMM on quality of care, patient outcomes, and savings generated. Analysis: Beneficial for managing polypharmacy Page 19 of 48 Contact: Position: Reduces DDI including herbal medications and OTCs Increases compliance Reduces readmission costs Pharmacists be able to bill Medi-Cal for CMM services provided Retail pharmacists have little time to provide CMM services Increases demand for pharmacists Liz Snow [email protected] Support Oppose CA Association of Health Plans has a position of “Watch” at this time Recommended Position: Support Recommended Priority: 1 Report Prepared by: Lily Zheng Date: 3/9/2016 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Report Bill Number: AB 2144 Author: Assemblymember Freddie Rodriguez Sponsor: Assemblymen Freddie Rodriguez Date Bill Entered: 02/17/16 X Original Subject: Amendment of Sections 4073.5 and 4074 of the Business and Professions Code regarding biologics. (Pharmacy; Prescriptions, Spot Bill) Digest: This bill proposes to establish requirements for substitutions of alternative biological products and establishes parameters for pharmacists when furnishing a prescription for a prescribed biological product. Page 20 of 48 Analysis: In regards to biological alternatives, there is only one currently available: filgrastim. Biosimilars are termed interchangeably as biological alternatives. The FDA has been writing policies to accelerate biosimilar approval. Biosimilars are termed as alternatives since these agents target the same receptors and same effects as biological products; however, there is no identical “generic” as these utilize a different molecular base and receptors and biologics are all proprietary technology. As biosimilars or biological alternatives are approved and become available, there is a potential savings in prescription drug pricing. This may be a potential increase of medication access to the patient. Still, the FDA has not termed the official naming convention and this issue may need to be addressed in the wording of the bill once the verbiage is finalized. Position: Support Introduced, currently pending for CPhA support Oppose None listed Recommended Position: Watch Recommended Priority: Priority 3 Report Prepared by: Jasmine Reber Date: 03/04/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: AB 2400 Author: Adrian Nazarian (D-Van Nuys) Sponsor: None Date Bill Entered: Date formally introduced 2/28/2016 Original Subject: Access to investigational drugs, biologics or devices for patients with lifethreatening conditions Digest: Requires plans and insurers to comply with a specified external exception request process for formulary drugs that require prior authorization by the plan or health insurer. Specifies that, for both non-formulary and formulary drugs, the external exception process is in Page 21 of 48 lieu of the health care service plan's grievance process and the health insurer's internal review process following an adverse benefit determination. Analysis: Existing federal law requires health plans to allow for both and internal and external appeal for coverage of non-formulary drugs This law would expand that provision to include formulary drugs requiring prior authorization Also requires response times that if not met require coverage Would require additional health plan process Potentially could get pharmacists in the middle of coverage decisions (although they already are) Contact: Position: Support Oppose None yet, CA Association of Health Plans has a position of “Watch” at this time Recommended Position: Watch Recommended Priority: 3 Report Prepared by: Thomas Pugh Date: 3/4/2016 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: AB 2436 Author: Hernandez, Roger; Assembly Member; Democrat; Chair of the Assembly Committee on Labor and Employment Sponsor: none Date Bill Introduced: 2/19/16 Page 22 of 48 Subject: Health care coverage: disclosures: drug pricing Summary: Would require a health care service plan contract or policy of health Insurance that is issued, amended, or renewed on or after 1/1/17, and that provides coverage for prescription drug benefits to notify the enrollee or insured of specified information related to the cost of a prescription drug at the time that the drug is purchased or delivered. Willful violation of the bill’s requirements would be a crime and would impose a state-mandated local program Analysis: The bill would require notification of the enrollee at the time of the medication delivery; 1. Thee enrollee’s share of the cost for the prescription drug and the accumulation of that cost sharing to the enrollee’s deductible, if any, or outof-pocket maximum, 2. Cost of the prescription drug to the plan after applying any discounts or rebates 3. Cost of the prescription drug in US dollars in Canada, Germany and Mexico Increased costs to healthcare service plans and insurance companies as well as increased time and cost to pharmacies dispensing the medication Recommended: Disapprove Recommended Priority : Bill Contact: Assembly member’s West Covina office (626) 960-4457 Report Prepared by: Date: 3 Gene Borrelli RPh, MBA 3/9/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: AB 2592 Page 23 of 48 Author: Assemblyman Jim Cooper Sponsor: author Date Bill Entered: Subject: Date formally introduced 2/19/16 Original Receiving delivery of Schedule II, III, IV Digest: Changes wording of Section 11209 of the Health and Safety Code. Section 11209 provides that an authorized person must sign for deliveries of Schedule II, III, IV merchandise. Type and quantity confirmed. Discrepancies must be reported to the delivering wholesaler or manufacturer by the next day after delivery. Analysis: Spot Bill. This bill would make non substantive changes to provision Contact: Roy Sianez, 916 319-2009 [email protected] Position: Support none Oppose none Recommended Position: watch Recommended Priority: 3 Report Prepared by: Lester Wong PharmD Date: 3/9/2016 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: AB 2593 Author: Assemblyman Jim Cooper Sponsor: author Date Bill Entered: Subject: Date formally introduced 2/19/16 Original Receiving delivery of Schedule II, III, IV Digest: Changes wording of Section 11209 of the Health and Safety Code. Section 11209 provides that an authorized person must sign for deliveries of Schedule II, III, IV merchandise. Type and quantity confirmed. Discrepancies must be reported to the delivering wholesaler or manufacturer by the next day after delivery. Page 24 of 48 Analysis: Spot Bill. This bill would make non substantive changes to provision Contact: Roy Sianez, 916 319-2009 [email protected] Position: Support none Oppose none Recommended Position: watch Recommended Priority: 3 Report Prepared by: Lester Wong PharmD Date: 3/9/2016 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Report Form Template Bill Number: AB 2810 Author: Eggman Sponsor: Eggman S (Asm); Wolk L (Sen) Date Bill Entered: Date formally introduced 2/19/16 Subject: End of life- Aid-in-dying prescription drugs Digest: Currently this is a spot bill Original Analysis: This bill would supplement ABX2-15, signed into law in October 2015, which will allow mentally stable, terminal patients with six months or less to live to seek a physician’s prescription for life-ending medication that would allow the patient to pass in a painless manner, rather than endure on-going pain and suffering prior to their impending death. This bill would directly affect pharmacists and the practice of pharmacy, given its explicit subject matter Page 25 of 48 As a spot bill, there is no substantive content at this time I have contacted Assemblywoman Eggman’s office requesting how much opposition and support the bill has and their assessment of likelihood of eventual passage. Contact: Gustavo Medina [email protected] Position: Support Oppose Recommended Position: Watch Recommended Priority: 3 Report Prepared by: Robert L. Stein, Pharm.D., J.D. Date: March 3, 2016 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: SB 323 Author: Ed Hernandez Sponsor: California Association for Nurse Practitioners Date Bill Entered: Subject: Date formally introduced 2/23/15 Most recently amended 7/9/15 Nurse Practitioner Scope of Practice Digest: This bill attempts to expand the scope of practice of nurse practitioners. It is a watered down modification of SB 491 from 2013 Analysis: SB 323 will grant NPs full practice authority, under a specified scope of practice, Support: California Association for Nurse Practitioners California Nurses Association Page 26 of 48 Opposed: California Medical Association Recommended Position: Watch Recommended Priority: 3 Report Prepared by: Date: Keith Yoshizuka 4/1/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: SB 423 Author: Senator Pat Bates Sponsor: author Date Bill Introduced: February 25, 2015 Subject: Retail nonprescription surplus products: determinations for reuse. Summary: This bill would additionally exclude from the definition of "pharmaceutical waste," for purposes of regulation under the act, any over-the-counter human or veterinary drug or dietary supplement that is, among other things, characterized and managed as a hazardous or solid waste and, with respect to an over-the-counter human or veterinary drug, is not disposed of on land within the state. Analysis: The amended bill will establish handling and management process for retail nonprescription pharmaceutical surplus products. The process would require the product to be transported to a reverse distributor or a reverse distribution center for evaluation, liquidation, donation, or transfer back to the manufacturer or supplier. This process would only apply to a pharmaceutical that may not be sold without a prescription and has been either determined to be eligible for reuse by a waste generator or is a recalled product. Therefore a pharmaceutical that is eligible for reuse would be defined as a product that is in unadulterated packaging, in a condition suitable for resale, and not designated for disposal. Recommended Position: Watch Page 27 of 48 Recommended Priority: 3 Bill Contact: Senator Pat Bates Report Prepared by: Richard Nunez Date: 03/07/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: SB952 Author: Senator Joel Anderson Sponsor: author Date Bill Introduced: 02/04/2016 Subject: Pharmacy Technician; Licensure Requirements Summary: Amended the requirements to practice as a pharmacy technician. They are removing the words (the Pharmacy Technician Certification Board) the Code is amended to read: 402. (4) Is certified by a pharmacy Technician organization offering a pharmacy technician program accredited by the National Commissions for Certifying Agencies that is approved by the board. Analysis: It is really not changing that much. The Pharmacy Technician Certification Board is now known as a Pharmacy Technician Organization. Discussion at joint CPhA/CSHP revealed that the alternate examination is not as stringent as PTCB, and there are already several PTCB certified technicians who are not competent. There was dissent among the GAAC committee between support and oppose, so the compromise was to watch. Recommended Position: Watch Recommended Priority: 3 Bill Contact: Senator Joel Anderson Report Prepared by: Richard Nunez Date: 03/05/16 Page 28 of 48 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: SB 992 Author: Senator J. Fuller (R) district 16 Sponsor: none Date Bill Entered: Date formally introduced Subject: Pharmacy Practice 2/10/2016 Original Digest: spot bill Analysis: Spot bill. 2/18/16 in committee Contact: Matt Hedges 916 651-4016 [email protected] Position: Support none Oppose none Recommended Position: Recommended Priority: Report Prepared by: Date: watch 3 Lester Wong PharmD 3/4/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: SB994 Author: Jerry Hill (D) district 13 Page 29 of 48 Sponsor: author sponsored Date Bill Entered: Date formally introduced 2/10/16 Amended 3/28/16 Subject: Outpatient health facilities; antimicrobial stewardship Digest: In its current form, this bill states an intent to enact legislation promoting antimicrobial stewardship in outpatient facilities Analysis: The bill in its original form has no teeth and no requirements. It only states an intent The amended bill requires clinics (including dental offices) to develop a plan for rational use of antimicrobials. The experts we consulted question how this would be enforced. Contact: Patrick Welch [email protected] Position: Support none Oppose none Recommended Position: Recommended Priority: Report Prepared by: Date: watch 3 Keith Yoshizuka 3/9/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: SB999 Author: Sen. Fran Pavley Sponsors: Sen. Fran Pavley, Sen Bob Herzog, Asm. Toni Atkins, Asm. Jimmy Gomez, Asm, Lorena Gonzalez, Sen. Ben Allen, Sen. Isadore Hall, Sen. Jerry Hill, Sen. Hannah-Beth Jackson, Sen. Connie Leyva, Asm. Bob Wieckowski, Asm. Autumn Burke, Asm. Cristina Garcia, Asm. Marc Levine, Asm. Kevin McCarty, Asm. Das Williams, Family Planning, Access, Care, and Treatment Page 30 of 48 (Family PACT) program (program administered by the Office of Family Planning), Planned Parenthood, NARAL Pro-Choice CA. Date Bill Introduced: 2/10/2016 Subject: Health insurance: contraceptives: annual supply Summary: Would require all insurance companies to cover a 12-month supply of FDAapproved, self-administered hormonal contraceptives dispensed at one time. A pharmacist could dispense the 12 month supply as prescribed or at the patient’s request unless the prescription specifically indicates no change in quantity. Analysis: Existing law allows a pharmacist to dispense no more than a 90 day supply at one time after a 30 day trial. I support this bill, but only if the 30 day trial remains required. I would also like to see an amendment that the patient cannot chose to receive a 12 mo supply but that that the prescriber must indicate on the prescription that a 12 month supply is appropriate based on their clinical knowledge and expertise. a. California Association of Health Plans: Watch b. California Family Health Council: Support c. Physicians of Reproductive Health: Rumor that they will also support I spoke with Dr. Pavley’s office and learned that currently OR and WA DC require private plans to cover a 12 mo supply. Four other states have introduced similar legislation this season (NY, WA, WI, HI). The aid at Dr. Pavley’s office was unsure if the other states require a 30 day trial period or if it is the patients choice. In the coming weeks they will be meeting with representatives of the health insurance industry including American Health Plans and the California Association of Health Plans to discuss details of the bill. To date they have not received any letters of opposition. Recommended Position: Watch Recommended Priority): 3 Bill Contact: Sen. Fran Pavley Report Prepared by: Karen Craddick Date: 3/7/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: SB 1174 Author: Sen. Mike McGuire. (Coauthors: Senators Beall, Hancock, Liu, and Mitchell) Sponsor: Mike McGuire, Jim Beall, Loni Hancock, Carol Liu, Holly Mitchell Date Bill Introduced: 2/18/16: Introduced Subject: Medi-Cal: children: prescribing patterns Summary (What does this bill do): Page 31 of 48 Would require the State Department of Health Care Services and State Department of Social Services to conduct ongoing analysis of Medi-Cal prescribers and prescribing patterns for all children enrolled in the Medi-Cal program. Data would be reported quarterly to the Medical Board of California and to the Legislature to determine if violations of law or deviations from the standard of care occurred. If they did, the Medical Board would investigate and take disciplinary action if necessary. Data would be broken down by categories such as children in foster care, juvenile hall, out-of-home care, with developmental disabilities. Analysis (Your thoughts about the bill): There is data reporting increased prescribing of antipsychotics, depression medications, ADHD medications and anti-anxiety medications for children. In some cases there is little data on the safety and efficacy in children for the use of these medications.1 These medications have side effects that potentially can have long term side effects. I support this bill to evaluate the current state of prescribing patterns for these vulnerable patient populations, however I do not think this is a high priority for CSHP. Also, it is unclear to me if a pharmacist could be subject to disciplinary action for dispensing medications found to be in violation of law or that deviate outside of the standard of care. Since it is the Medical Board that will be tasked with disciplinary action I would assume not unless they worked with the Board of Pharmacy. Recommended Position (Support, Oppose, Watch): Watch Recommended Priority (1-3): 3 Bill Contact: Rashad at Senator McGuires office, no fact sheet on SB 1174. Office #: 916651-4002. Was told to e-mail Kelly Burns for more information: [email protected]. Kelly is the aid working on health care bills. I e-mailed Kelly but have not heard back. Report Prepared by: Date: Karen Craddick 3/7/16 1 http://www.healthline.com/health-news/experts-alarmed-over-use-of-antipsychotic-drugs-onchildren-070115 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: SB 1193 Author: ASM Jerry Hill (D) District 13 Sponsor: Author sponsored Date Bill Entered: Subject: Date formally introduced 2/18/16 Original California State Board of Pharmacy: executive officer Page 32 of 48 Digest: The Board of Pharmacy is subject to a sunset clause; currently January 1, 2017. This bill would extend the existence of the Board of Pharmacy until January 1, 2021. Analysis: The California State Board of Pharmacy performs a useful function in this state The costs of doing business for the Board of Pharmacy is covered entirely by fee collected. No tax revenues are allocated to fund the Board of Pharmacy The Board of Pharmacy has supported and collaborated with CSHP in the past to achieve mutually aligned goals Contact: Sarah Mason, Senate Business & Professions Committee [email protected], (916) 651-4104 Position: Support none on record yet Oppose none on record yet Recommended Position: Support Recommended Priority: 3 Report Prepared by: Keith Yoshizuka Date: 3/3/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: SB 1217 Author: SEN Jeff Stone (R) 28th district Sponsor: Author sponsored Date Bill Entered: Subject: Date formally introduced 2/18/16 Original Healing arts: reporting requirements: professional liability Page 33 of 48 Digest: Existing law requires that the individual historical record contain any reported judgment or settlement requiring the licensee or the licensee’s insurer to pay over $3,000 in damages for any claim that injury or death was proximately caused by the licensee’s negligence, error or omission in practice, or rendering unauthorized professional service. This bill would instead require the record to contain reported judgments or settlements with damages over $10,000. Analysis: This statute was developed in the 1960s. Since that time, inflation has occurred (gasoline used to be 19¢ per gallon in the 1960s $10,000 is the new $3,000. It is not unusual to dispose of nuisance suits because the costs of litigation exceed $10,000. Any significant claim for damages will exceed $10,000 in damage awards Contact: Bijan Mehryar [email protected], 916-651-4028 Position: Support none on record yet Oppose none on record yet Recommended Position: Recommended Priority: Report Prepared by: Date: Support 3 Keith Yoshizuka 3/3/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: SB 1220 Author: Mike McGuire Sponsor: Mike McGuire (D – District 2) Date Bill Introduced: 03/03/2016 Mar. 3 Referred to Coms. on HUMAN S. and JUD. 02/19/2016 Feb. 19 From printer. May be acted upon on or after March 20. 02/18/2016 Feb. 18 Introduced. Read first time. To Com. on RLS. for assignment. To print Page 34 of 48 Subject: Foster Care: psychotropic medication Summary (What does this bill do): Under existing law, only a juvenile court judicial officer may make orders regarding the administration of psychotropic medications for a dependent child or a ward of the court who has been removed from the physical custody of his or her parent, as specified. Existing law requires court authorization for the administration of psychotropic medication to be based on a request from a physician, indicating the reasons for the request, a description of the child's or ward's diagnosis and behavior, the expected results of the medication, and a description of any side effects of the medication. Existing law requires the officer to approve or deny the request for authorization to administer psychotropic medication, or set the matter for hearing, as specified, within 7 court days. This bill would instead require the officer to take one of those actions within 5 court days. Analysis (Your thoughts about the bill): I do not believe that this bill will have any direct impact on the profession of pharmacy. Recommended Position (Support, Oppose, Watch): Watch Recommended Priority (1-3): Priority 3 Bill Contact: Kay at District Office (916) 651-4002 According to Kay, the text of the bill will be substantially, if not entirely, changed within the next 7-10 days. It was not worth a discussion in its current state. Report Prepared by: Chris Mapes Date: 3/7/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: SB 1229 Author: Senators Jackson Sponsor: Senators Jackson and Stone Date Bill Entered: Subject: 2/18/16 Pharmacies: secure drug take-back bins Page 35 of 48 Digest: This bill would require a pharmacy that owns or operates a secure drug take-back bin, as defined, in a publicly accessible location to take reasonable steps to ensure the proper disposal of the pharmaceutical waste contained in the bins. The bill would provide that the owner or operator is not liable for civil damages arising from the use of the secure drug take-back bin if the owner or operator takes reasonable steps, as specified, to ensure the health and safety of consumers and employees and the proper disposal in the waste stream of the pharmaceutical waste contained in the bins. By expanding the application of a crime, the bill would impose a state-mandated local program. Analysis: Requires a pharmacy that owns or operates a secure drug take-back bin, in a publicly accessible location to take reasonable steps to ensure the proper disposal of the pharmaceutical waste contained in the bins. provides that the owner or operator is not liable for civil damages arising from the use of the secure drug take-back bin if the owner or operator takes reasonable steps, to ensure the health and safety of consumers and employees and the proper disposal. Contact: Position: Support None Oppose None Recommended Position: Watch Recommended Priority: 3 Report Prepared by: Date: Lester Wong PharmD 3/4/2016 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Report Form Bill Number: SB 1230 Author: Jeff Stone, PharmD (R) 28th district Sponsor: author sponsored Date Bill Entered: Subject: Date formally introduced 2/18/16 Pharmacies; compounding Page 36 of 48 Digest: This bill would authorize a pharmacy that provides compounding services to provide to a clinic commercial products that are unique or otherwise unavailable to the clinic, if the compounding pharmacy and the clinic have entered into a professional compounding services agreement to provide nonpatient-specific compounded medications that cannot be planned for prospectively. The bill would require the board to adopt regulations for establishing a professional compounding services agreement. Analysis: This bill establishes requirements for pharmacies compounding for doctor’s offices not for any specified patient, and for the BOP to establish regulations for this process. Used to be addressed by CCR 1716.1 Compounding unapproved drugs for Prescribers Office Use, but was repealed 7/6/2010 I am working with the office to see if there is existing law that covers this issue Contact: Chris Norden [email protected] Position: Support none yet Oppose none yet (PHARMA?) Recommended Position: Watch Recommended Priority: 3 Report Prepared by: Date: Keith Yoshizuka 3/10/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Report Form Bill Number: SB 1335 Author: Holly Mitchell (D) district 30 Sponsor: TBD Date Bill Entered: Subject: Date formally introduced 2/19/16 Welfare & Institutions Code; MediCal Page 37 of 48 Digest: This bill would authorize FQHCs and RHCs to elect to have Drug Medi-Cal and specialty mental health services reimbursed on a fee-for-service basis, according to the same criteria as applied to pharmacy and dental services. Analysis: Affects Federally Qualified Health Centers (FQHC) and Rural Health Clinics Requires reimbursement similar to pharmacy & dental services Contact: Chelsea David [email protected] Position: Support none. Oppose none Recommended Position: watch Recommended Priority: 3 Report Prepared by: Date: Keith Yoshizuka. 3/10/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: SB 1346 Author: Ben Allen Sponsor: Ben Allen (D 26th district) Date Bill Introduced: 03/03/2016 Mar. 3 Referred to Com. on B., P. & E.D. Subject: Pharmacists: Drug Labeling: medication guides: electronic delivery Summary (What does this bill do): This bill would authorize a pharmacist to offer to a patient, as an alternative to a printed paper medication guide for a prescription drug as required by the United States Food and Drug Administration, the electronic delivery of the medication guide. The bill would authorize a Page 38 of 48 pharmacist to deliver the medication guide by electronic means if the patient chooses electronic delivery. Support: None Oppose: None Analysis: The production and mandated furnishing of a Medication Guide is an essential tenant of protecting public health. An ability to provide an electronic copy of this information directly to a receptive patient would greatly facilitate the education of that patient and could lead to a more informed patient/public. From a business perspective, this bill would allow the reduction of printing efforts/cost within the pharmacy and increase connectivity between the patient and pharmacists as the patient would have to supply an active email address to participate in the edelivery of this information. Workflows could be further positively impacted if the delivery process was automated. I feel that CSHP should support this piece of legislation and educate its membership to the delivery options it may or may not produce for them in the future. Recommended Position (Support, Oppose, Watch): Support Recommended Priority (1-3): Priority 2 Bill Contact: Josh Cohen [email protected] (916) 651-4026 (Capital Office) Report Prepared by: Chris Mapes Date: 3/7/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: SB 1454 Author: Stone Sponsor: N/A Date Bill Entered: Date formally introduced Subject: Pharmacy Law (Spot Bill) Digest: No substantive content as of this review 2/19/16 Original Page 39 of 48 Analysis: Because this bill refers to Pharmacy Law, BPC 4001 et seq., subsequent amendments will likely have a direct impact on pharmacies, and pharmacists. Its impact on hospitals is unknown at this time. Unable to predict likelihood of passage until amended with substantive content. Contact: Chris Norden [email protected] (pending response 3/3/16) Position: Support N/A at this time Oppose N/A at this time Recommended Position: Watch Recommended Priority: 3 Report Prepared by: Date: Robert L. Stein, Pharm.D, J.D. February 29, 2016 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Report Bill Number: SCR-109 Author: Senator Jeff E. Stone Sponsor: California Pharmacists Association, Supannee Lertpaichaiyon (Touro P2 student in Senator Stone’s district)) Date Bill Entered: Subject: February 12, 2016 X Original California Pharmacists Outreach Week Digest: To declare California Pharmacist Outreach Week annually starting February 12, 2016 to February 21, 2016 and thereafter where student pharmacists may be able to perform outreach and preventative services to the community, which includes, but not limited to health fairs, blood drives, preventative education and poison prevention. Events will target health conditions such as (not all inclusive) hypertension, diabetes, high cholesterol, tobacco cessation, immunizations, and reproductive health. Page 40 of 48 Analysis: This bill may potentially increase pharmacy student outreach by dedicating awareness in the patient community. In the student level, ASHP advocates for students to design and implement activities promoting pharmacists’ interventions and activities that may impact patient outcomes. These include, but not limit to influenza immunization initiative, anticoagulation resource for patients, and antimicrobrial practices. The purpose of these events is to acquaint students early in education to not only provide services to the community, but to undertake roles and responsibilities as they enter into practice post-graduation. There is little opposition to the bill as currently pharmacy students from California have been participating in outreach events. Contact: Position: Brittny Garcin Email: [email protected] Support California Pharmacists Association Oppose None Recommended Position: Support if amended. The bill has already passed the senate but is stuck in the assembly because the date of the declaration has already passed. We would recommend that the bill be amended to declare the third week of February annually as California Pharmacists Outreach Week. Recommended Priority: Report Prepared by: Date: Priority 1 Jasmine Reber March 4, 2016 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: HR 592 Authors: Brett Guthrie (R. KY-2), G. K. Butterfield (D. NC-1), & Todd C. Young (R. IN-9) Sponsor: APhA, NCPA, NACDS) Date Bill Introduced: January 28, 2015 Subject: To amend Title XVIII of the Social Security Act (Medicare) to cover pharmacist services Summary: HR 592, Pharmacy and Medically Underserved Areas Underserved Enhancement Act will amend Title XVIII of the Social Security Act to allow pharmacist services as legally authorized by the State in underserved areas of primary care physicians (defined by Public Health Services Act) to be covered by Medicare. These services would otherwise be covered when performed by physicians. Analysis: This bill would expand health services to specifically to the underserved areas in Page 41 of 48 California of where there is an insufficient supply of primary care providers to meet the demand of patients. There are minimal costs for development or implementation as the Board of Pharmacy and the Medical Board of California are establishing pharmacists’ services under SB 493. To facilitate implementation, the Secretary of Human Health Services shall designate pharmacist specific codes under the physician fee schedule of the Social Security Act. HR 592 currently has 269 co-sponsors. There are 435 members in the House of Representatives. Therefore, at 61.8%, it has enough votes to pass the House. However, there are only 41 cosponsors of S 314 on the senate side (out of 100 senators). Supported by the Patient Access to Pharmacists’ Care Coalition, who is composed of: Albertson’s LLC and New Albertson’s Inc.,,American Association of Colleges of Pharmacy, American Pharmacists Association, American Society of Consultant Pharmacists, American Society of Health-System Pharmacists, AmerisourceBergen, Association of Clinicians for the Underserved, BI-LO Pharmacy, Cardinal Health, CVS Health, Food Marketing Institute, Fred’s Pharmacy, Fruth Pharmacy, Healthcare Distribution Management Association, Healthcare Leadership Council, Hematology/Oncology Pharmacy Association, International Academy of Compounding Pharmacists, Kroger, McKesson, National Alliance of State Pharmacy Associations, National Association of Chain Drug Stores, National Center for Farmworker Health, National Community Pharmacists Association, National Consumers League, National Patient Advocate Foundation, National Pharmaceutical Association, National Rural Health Association, Omnicell Pediatric Pharmacy Advocacy Group, Rite Aid Pharmacy, Safeway, SUPERVALU Pharmacies, Target, Thrifty White Pharmacy, Walgreens, WalMart, Winn-Dixie Pharmacy, Recommended Position: Support Recommended Priority (1-3): 1 Bill Contact: Naomi Mitchell, (301) 664-8657, [email protected], Report Prepared by: Keith Yoshizuka/Jasmine Reber Date: 03/03/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: S 314 Authors: Robert P. Casey (Dem-PA), Mark Kirk (Rep-IL), & Sherrod Brown (Dem-OH) Sponsor: American Pharmacists Association (APhA), National Community Pharmacists Association (NCPA), National Association of Chain Drug Stores (NACDS) Date Bill Introduced: January 29, 2015 Subject: Companion bill to HR 592 to amend Title XVIII of the Social Security Act (Medicare) to cover pharmacist services Page 42 of 48 Summary: Both HR 592 and S 314, the Pharmacy and Medically Underserved Areas Underserved Enhancement Act will amend Title XVIII of the Social Security Act to allow pharmacist services as legally authorized by the State in underserved areas of primary care physicians (defined by Public Health Services Act) to be covered by Medicare. These services would otherwise be covered when performed by physicians. Analysis: This bill would expand health services to specifically to the underserved areas in California of where there is an insufficient supply of primary care providers to meet the demand of patients. There are minimal costs for development or implementation as the Board of Pharmacy and the Medical Board of California are establishing pharmacists’ services under SB 493. To facilitate implementation, the Secretary of Human Health Services shall designate pharmacist specific codes under the physician fee schedule of the Social Security Act. HR 592 currently has 269 co-sponsors. There are 435 members in the House of Representatives. Therefore, at 61.8%, it has enough votes to pass the House. However, there are only 41 cosponsors of S 314 on the senate side (out of 100 senators). Supported by the Patient Access to Pharmacists’ Care Coalition, who is composed of: Albertson’s LLC and New Albertson’s Inc.,,American Association of Colleges of Pharmacy, American Pharmacists Association, American Society of Consultant Pharmacists, American Society of Health-System Pharmacists, AmerisourceBergen, Association of Clinicians for the Underserved, BI-LO Pharmacy, Cardinal Health, CVS Health, Food Marketing Institute, Fred’s Pharmacy, Fruth Pharmacy, Healthcare Distribution Management Association, Healthcare Leadership Council, Hematology/Oncology Pharmacy Association, International Academy of Compounding Pharmacists, Kroger, McKesson, National Alliance of State Pharmacy Associations, National Association of Chain Drug Stores, National Center for Farmworker Health, National Community Pharmacists Association, National Consumers League, National Patient Advocate Foundation, National Pharmaceutical Association, National Rural Health Association, Omnicell, Pediatric Pharmacy Advocacy Group, Rite Aid Pharmacy, Safeway, SUPERVALU Pharmacies, Target, Thrifty White Pharmacy, Walgreens, WalMart, Winn-Dixie Pharmacy, Recommended Position: Support Recommended Priority (1-3): 1 Bill Contact: Naomi Mitchell, (301) 664-8657, [email protected], Report Prepared by: Keith Yoshizuka/Jasmine Reber Date: 03/03/16 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: CCR 1744 Page 43 of 48 Author: Sponsor: Title 16, California Board of Pharmacy Date Bill Introduced: Subject: Drug Warnings Summary: The proposed regulation amends CCR section 1744 to include the written label requirement. Additionally, the drug classes requiring the written label are being amended and updated based on discussions with industry professionals. The drug classes identified in this regulation have not been amended this 1983. As new drug classes have been established that may impair a person’s ability to drive a motor vehicle or operate machinery or may have harmful effects if taken in combination with alcohol, it is necessary to amend and update the regulation. Analysis: This proposal will increase patient and consumer awareness and safety regarding the potentially dangerous side-effects of certain prescription drugs. The use of a warning label on a prescription medication bottle will serve to remind and educate patients as to the possible adverse side effects of certain prescription drugs and the increased risks associated with consuming alcohol or other drugs when taking specific drugs. Recommended Position: Watch Recommended Priority: 3 Bill Contact: California Board of Pharmacy Report Prepared by: Richard Nunez Date: 03/08/16 California Board of Pharmacy Patient-Centered Labels for Prescription Drug Containers: Requirements Pending Legislation would amend the following sections of Title 16, California Code of Regulations Section 1707.5: “…(a) Labels on drug containers dispensed to patients in California shall conform to the following format: Page 44 of 48 (1) Each of the following items, and only these four items, shall be clustered into one area of the label that comprises at least 50 percent of the label. Each item shall be printed in at least a 12point sans serif typeface, and listed in the following order: (A) Name of the patient (B) Name of the drug and strength of the drug. For the purposes of this section, “name of the drug” means either the manufacturer's trade name of the drug, or the generic name and the statement “generic for _____” where the brand name is inserted into the parentheses. If it has been at least five years since the expiration of the brand name’s patent or, if in the professional judgment of the pharmacist, the brand name is no longer widely used, the label may list only the generic name of the drug and outside of the patient centered area, the name of the manufacturer. (C) The directions for the use of the drug. (D) The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription…” “…(d) The pharmacy shall have policies and procedures in place to help patients with limited or no English proficiency understand the information on the label as specified in subdivision (a) in the patient's language. The pharmacy's policies and procedures shall be specified in writing and shall include, at minimum, the selected means to identify the patient's language and to provide interpretive services and translation services in the patient's language. The pharmacy shall, at minimum, provide interpretive services in the patient's language, if interpretive services in such language are available, during all hours that the pharmacy is open, either in person by pharmacy staff or by use of a third-party interpretive service available by telephone at or adjacent to the pharmacy counter…” Recommendation: The updated language of Section (a) appears to be straightforward and agreeable. Updating Section (d) could cause greater disruption of the Pharmacy Profession. Per the board’s website, the 45-day comment period is over, but I feel that this is an issue that CSHP may want to comment on (if it has not already) as the inclusion of “shall” combined with the directive inclusive of all possible languages is a concern and the mechanics of supplying such a service could greatly impact patient care. Recommended Position: Watch Recommended Priority: 3 Prepared By: Chris Mapes Date: 3/8/16 Bill Analysis Report California Society of Health-System Pharmacists Page 45 of 48 Government Affairs Advisory Committee Bill Number: CCR 1715.65 Author: California Board of Pharmacy Sponsor: California Board of Pharmacy Date Regulation Entered: Subject: Text Approved by Board July 29, 2015, Initial Statement of Reasons October 16, 2015 Original Reconciliation and Inventory Report of Controlled Substances Digest: This proposal will require pharmacies and clinics licensed under BPC sections 4180 or 4190 to perform, at minimum, a quarterly physical count inventory of all Schedule II controlled substances and at least one additional controlled substance as identified by the Board based on drug loss reports. Also mandates a pharmacy develop policies and procedures for inventories and reconciliations. Analysis: Requires a physical count of all Schedule II controlled substances and at least one other controlled substance as determined by the Board of Pharmacy Requires the PIC in a pharmacy, or the consultant pharmacist for a clinic, to review all controlled substance reconciliations and inventories, and to establish and maintain secure methods to prevent loss of controlled substances. Written policies and procedures must be developed that ensure consistency of reconciliation and inventory processes The feasibility of hospitals and health systems to be able to reconcile administration and purchase of thousands of doses in not reasonable. In systems with a perpetual inventory would touching the medication and performing a count at least every 3 months count or would the entire stock have to be inventoried on the same day? Cedars-Sinai Medical Center and I recommend that the BOP focus on requiring hospitals to create robust controlled substance surveillance programs that include retrospective and prospective review of controlled substance purchases, administrations and waste.. Such a program should include audits of inpatient, outpatient and procedural areas. It should encompass audits of nursing, physician and pharmacy staff. The program should use existing tools available through automated dispensing cabinet vendors and other surveillance program vendors. Requiring such programs in hospitals would be similar to the requirement that a hospital have an antimicrobial stewardship program. Recommended Position: Oppose unless amended; regulation is designed for retail pharmacies. Does not account for complexities of hospitals Recommended Priority: Report Prepared by: 2 Robert Stein and Karen Craddick Page 46 of 48 Date: 3/8/2016 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Number: CCR1746.5 Author: California Board of Pharmacy Sponsor: Date Bill Entered: Subject: Date formally introduced 6/04/2015 Changes to the requirements of pharmacists for furnishing travel medications Digest: Documentation for a pharmacist who furnishes travel medications shall be kept on site and available for inspection by the Board includes immunization certificate, completion of 10hour travel medicine training program covering each medication related element of the International Society of Travel Medicine’s Body of Knowledge for the Practice of Travel Medicine, completion of the CDC Yellow Fever Vaccine Course, and BLS certification. Pharmacist shall notify patient’s PCP within 30 days of furnishing travel medications or devices. Analysis: Time period to notify PCP changed from 90 days to 30 days. Travel medicine training program hours changed from minimum 20 hours to 10 hours Travel medicine training programs focuses on “medication related” elements. Changed “completion of an approved immunization training program” to “completion of an immunization certification program that meets the requirements of Business and Professions Code section 4052.8(b)(1).” Contact: Position: Support Oppose 9 members of the CA BOP at the January 2016 meeting 0 members of the CA BOP Recommended Position: Recommended Priority: Report Prepared by: support 3 Lily Zheng Page 47 of 48 Date: 3/9/2016 Bill Analysis Report California Society of Health-System Pharmacists Government Affairs Advisory Committee Bill Report Form Bill Number: CCR Misc. Compounded Drugs Author: Board of Pharmacy Sponsor: Date Bill Entered: Date formally introduced 6/25/16 Amendment 7/31/16 Amendment 3/8/15 Original 1/19/16 Amendment Subject: Compounded Drugs Digest: Adds specific requirements for controls and records for sterile compounding Analysis: Too voluminous to discuss in detail, but most of the pharmacy directors who viewed it feel that it is appropriate. Contact: Position: Support N/A Oppose N/A Recommended Position: Watch (and notify members when it becomes effective) Recommended Priority: 3 Report Prepared by: Date: Keith Yoshizuka 3/10/16 Page 48 of 48
