5ESSB 5857 Regulation Pharmacy Benefit Managers Signed into law April 1, 2016

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1 WSPA/LRAC Bill Tracking Update April 18, 2016 FINAL REPORT 5ESSB 5857 Regulation Pharmacy Benefit Managers Signed into law April 1, 2016 Transfers regulatory oversight of Pharmacy Benefit Manager (PBMs) and establishes a registration fee setting authority to the Office of the Insurance Commissioner (OIC). Appeal process modified: Definitions modified including: MAC modified to predetermined reimbursement costs such as multisource generic drug; All drugs on the list must be readily available in this state from wholesalers that serve pharmacies in Washington Pharmacies may bring an appeal to the PBM if their reimbursement is less than the net amount they paid for the drug. The appeal must be complete in 30 days Requires the PBM to uphold an appeal of a pharmacy with fewer than 15 retail outlets in Washington if the pharmacy can demonstrate it is unable to purchase a therapeutically equivalent product from a supplier in Washington at the PBM s list price If successful with the appeal, the PBM must make a reasonable adjustment If unsuccessful, a pharmacy with fewer than 15 retail outlets in Washington may have a second level review with the OIC. Pharmacies with more than 15 retail outlets may provide information to the OIC on their appeals for collection and analysis The OIC may authorize the appeals be conducted by the Office of Administrative Hearings The OIC with the Department of Health (DOH), must review the potential to use Independent Review Organizations for the appeal process and report to the Legislature by 12/1/16 The OIC must conduct a study of the pharmacy chain of supply with delivery to the Legislature by 11/1/16 The PBM must provide information on appeals for retail pharmacies with more than 15 retail outlets for the study. November 1, Pharmacy chain of supply study due to Legislature January 1, Transfer of PBM registration fee and some oversight to the OIC July 1, Pharmacies with fewer than 15 outlets may dispute their PBM appeal and request a review by the OIC if their appeal to the PBM was denied or they are unsatisfied with the outcome HOUSE OF REPRESENTATIVES PASSED: 94-3 SENATE PASSED:

2 2SSB 6203 Updating Statues Relating to the Practice of Pharmacy in Long Term Care In 2015, through a budget proviso in the state s Operating Budget, the Legislature directed the Pharmacy Quality Assurance Commission (PQAC) to develop statutory standards and protocols specific to Long Term Care (LTC) pharmacies. During the 2015 interim, the PQAC and the Department of Health (DOH) met with stakeholders to address the practice of pharmacy in LTC settings. The work group was tasked with the development of a report that was to be submitted to the Legislative Health Care Committees by November The report included draft statutory language provided by the Washington State Pharmacy Association and the Washington Health Care Association that was ultimately incorporated in SB Provisions of Long Term Care Facilities - Pharmacy Services A licensed nurse, pharmacist, or physician practicing in a LTC facility or hospice program may act as a practitioner's agent to document a chart order in the patient's medical record pending the prescribing practitioner's signature and may communicate a prescription to a pharmacy A pharmacy may dispense prescription drugs to a resident of a LTC facility or hospice program on the basis of a written or electronic prescription or chart order. A nurse, pharmacist, or physician receiving and recording an oral medication order may communicate that order to a pharmacy on behalf of the prescribing practitioner. Prescriptions for Schedule III, IV, or V controlled substances for a resident of a LTC facility or hospice program may be communicated to the pharmacy by an authorized agent of the prescriber. Authorized agents include registered nurses, pharmacists, or physicians working at the facility or program A pharmacy or pharmacist may provide a limited quantity of drugs to a nursing home or hospice program to be used in emergency kits to be administered under a prescription by authorized facility personnel. These drugs must meet the immediate therapeutic needs of residents or patients and not be available from another source If a nursing home uses a unit dose drug distribution system, it may maintain a supplemental dose kit for supplemental nonemergency drug therapy. The types of drugs used in emergency kits and supplemental dose kits must be determined by a pharmaceutical services committee whose membership includes a pharmacist, a physician, an osteopathic physician, an advanced registered nurse practitioner, and representatives of the nursing home or hospice program Emergency kits and supplemental dose kits may be restocked by a licensed practical nurse operating under the supervision of a pharmacist Shared pharmacy services allow a pharmacy to request another pharmacy to fill a prescription or drug order. These services may be used to ensure that drugs or devices are available to meet the immediate needs of residents of a LTC facility or hospice program. The supplying pharmacy must keep a copy of the prescription or order on file and must notify the outsourcing pharmacy of the service provided A pharmacy may repackage and dispense unused drugs returned by a LTC facility or hospice program if the drugs are in per-use, blister packaging Chart orders of institutional facilities will be considered prescriptions if they contain specified elements Allows a pharmacy to outsource services for a LTC facility or hospice program Directs the PQAC to establish task-based standards for the ratio of pharmacists to pharmacy technicians for certain long-term care pharmacies 90 days

3 SENATE PASSED: 48-0 HOUSE OF REPRESENTATIVES PASSED: SSB 6558 Allowing a hospital pharmacy license to include individual practitioner offices and multipractitioner clinics owned and operated by a hospital and ensuring such offices and clinics are inspected according to the level of service provided Signed into law March 31, 2015 The 2015, the Legislature passed ESSB 5460 allowing hospitals to transfer medications to their clinics, and allowed the hospital license to include any individual practitioner's office or multi-practitioner clinic owned and operated by a hospital to be identified by the hospital on the hospital pharmacy license application or renewal. The legislation was intended to streamline the regulatory process and to avoid individually licensing all hospital owned clinics and practices as pharmacies. During the 2015 interim, stakeholders identified areas in ESSB 5460 that needed clarification. SSB 6558 Clarifies provisions regarding allowing hospital pharmacy licenses to include individual practitioner offices and multi-practitioner clinics owned, operated, or under common control with a hospital. Requires interpretation of the provisions regulating the practice of pharmacy to be in a manner that supports regulatory, inspection, and investigation standards that are reasonable and appropriate based on the level of risk and the type of services provided in a pharmacy. Provides timelines in which the Pharmacy Quality Assurance Commission must adopt rules regarding pharmacy inspection standards and updates to application or renewal forms for hospital pharmacy licenses. June 9, 2016 : Senate 49 0 House SHB Providing for Suicide Awareness and Prevention Education for Safer Homes This bill establishes a Safe Homes Task Force to develop suicide awareness and prevention education messages and training and implement advocacy efforts with key stakeholders to pair suicide prevention training with distribution of devices for safe storage of lethal means. The safe homes task force consists of the members comprised of suicide prevention and firearms subcommittee and a suicide prevention and pharmacy subcommittee. The subcommittee will consist of the following members: Two representatives of the Washington State Pharmacy Association; Two representatives of retailers who operate pharmacies, selected by the co-chairs of the subcommittee;

4 One faculty member from the University of Washington School of Pharmacy and one faculty member from the Washington State University College of Pharmacy; One representative of the Department of Health; One representative of the Pharmacy Quality Assurance Commission; Two representatives of the Washington State Poison Control Center; One representative of the Department of Veterans Affairs, and one other individual representing veterans to be selected by the co-chairs of the subcommittee; and No more than two other interested parties, selected by the co-chairs of the subcommittee. The task force will be administered and staffed by the University of Washington School of Social Work. The University of Washington School of Pharmacy and Washington State University College of Pharmacy must convene a work group to develop a curriculum for pharmacy students on suicide assessment, treatment, and management. The bill also requires licensed pharmacists to complete a one-time training on suicide assessment, treatment, and management. 90 days January 1, 2017 Suicide assessment training SENATE PASSED: 47-0 HOUSE CONCURRED AND PASSED: SHB 2681 Concerning Contraceptives in Pharmacies Bill summary: The Pharmacy Quality Assurance Commission (PQAC) must develop a sticker or sign to be displayed on the window or door of a pharmacy that initiates or modifies drug therapy related to self-administered hormonal contraceptives. This language in this bill changed many times over the legislative process. While the WSPA supported the intent of the bill, the finer points outlined in the bill were not ideal. In it s original form, the bill authorized pharmacists to prescribe and dispense self-administered hormonal contraceptives ONLY to a patient who is at least 18 years old. The original bill also did not allow for a pharmacist to schedule an appointment with a patient and restricted the contraceptive options in law. Other women s health advocates expressed concerns over these provisions. The Washington State Medical Association opposed the bill in its original form citing the CDTA process is sufficient and works. They did acknowledge that more CDTAs for contraception are needed. After many bill iterations and numerous hearings and testimonies, legislators agreed that the current CDTA process is sufficient to maintain and that an increase in CDTAs may be needed. The WSPA supported the intent of the bill as it moved through the process and testified wholeheartedly in support of the pharmacist s ability to increase patient access to contraception. We worked with the Washington State Medical Association to increase the awareness of CDTAs and identify areas in the state where CDTAs for contraception can be more readily available and work on improving access across the state.

5 The final outcome of the bill recognizes the current CDTA process between a pharmacy/pharmacists and prescribers without hindering current practices and directs pharmacies that have pharmacists with a CDTA to prescribe and dispense contraception to display a sticker or sign on the window or door of a pharmacy. PQAC will develop a sticker or sign to be displayed. 90 days HOUSE OF REPRESENTATIVES PASSED: 92-4 SENATE PASSED: ESSB 2335 Health Care Provider Credentialing Signed into law March 31, 2015 Health care providers, including pharmacists who will be billing medical claims starting in 2017, are required to submit credentialing applications to a single credentialing database and health carriers are required to accept and manage credentialing applications from the database. Effective June 1, 2018, a health carrier must make a determination approving or denying a credentialing application submitted to the carrier no later than 90 days after receiving a complete application from a health care provider. Effective June 1, 2020, the average response for the health carrier to make a determination regarding the approval or denial of a provider's credentialing application must not exceed 60 days. A health carrier is not required to approve a credentialing application that is submitted to it, nor is it required to place health care providers into a network. If there is a credentialing delegation arrangement between a facility that employs health care providers and a health carrier, then the single credentialing database is not required to be used. The Office of the Insurance Commissioner (OIC) does not have an oversight or enforcement duty against a health carrier for the health carrier's failure to comply with provisions related to the use of the credentialing database. Healthcare providers must update their credentialing information as necessary to provide for the purposes of recredentialing. June 1, health carriers must approve/deny a credentialing application within 90 days. June 2, the average response time for approval/denial reduced to 60 days. SENATE PASSED: 48-0 HOUSE OF REPRESENTATIVES PASSED:

6 HB 2350 Defining the Administration of Medication by Medical Assistants All credentialed medical assistants, excluding medical assistant-phlebotomists, may administer some medications. It is the responsibility of the health care practitioner to determine that the delegation of a task is appropriate and is not prohibited by law. The bill updates current law to specify that a medical assistant's ability to "administer" medication means both the retrieval and application of medication. 90 days SENATE PASSED: 42-6 HOUSE OF REPRESENTATIVES PASSED: ESHB 2458 RX Donation Program "Cancer Can't Charitable Pharmacy Act" Individuals may donate unused prescription drugs that meet certain quality standards to a pharmacy for redistribution to patients at no cost. Individual persons and their representatives are added to the types of donors who may donate unused drugs to a pharmacy for redistribution under the prescription drug donation program. Individual persons who wish to donate to the program must complete and sign a donor form, developed by the Department of Health, to authorize the release and certify that the donated prescription drugs have not been opened, used, adulterated, or misbranded. A pharmacist must, in his or her professional judgment, determine that the drugs were stored under required temperature conditions using the drug s time temperature indicator information. The term "time temperature indicator" means a device or smart label that shows the accumulated time-temperature history of a product through the entire supply chain. Prescription drugs that require registration with the drug's manufacturer may be accepted under the prescription drug donation program and may be dispensed if the patient is registered with the manufacturer at the time of dispensing and the amount does not exceed the duration of the registration period. The liability protections that apply to drug manufacturers are clarified to expressly apply to prescriptions drugs that may only be dispensed to a patient who is registered with the drug's manufacturer. January 1, 2017 SENATE PASSED: 47-0 HOUSE OF REPRESENTATIVES PASSED:

7 HB 5549 Registration and Disciplining of Pharmacy Assistants WA State Legislature overrode Governor Inslee s VETO Pharmacy assistants can perform certain duties under the supervision of a pharmacist. Duties include typing of prescription labels, filing, bookkeeping, pricing, stocking, delivery, nonprofessional phone inquiries, and documentation of third-party reimbursements. Pharmacy assistants must be registered with the Department of Health (DOH). Currently, the DOH does not charge a fee for that registration other pharmacy professions cover the cost of regulating pharmacy assistants. The bill authorizes the DOH to establish registration fees for pharmacy assistants. Pharmacy assistants are subject to disciplinary action of the Pharmacy Quality Assurance Commission and the Uniform Disciplinary Act. 90 Days. SENATE PASSED 47-2 HOUSE PASSED GOVERNOR VETOED NOTE: The Washington State Legislature convened its special session and during the special session they successfully took action to override the Governor s veto of the bill. SENATE OVERRODE THE GOVERNOR S VETO: 41-2 HOUSE OF REPRESENTATIVES OVERRODE THE GOVERNORS VETO: SSB 6569 Creating a task force on high out-of-pocket prescription drug cost WA State Legislature overrode Governor Inslee s VETO Bill requires the Department of Health (DOH) to convene a task force by July 1, 2016 to examine the factors contributing to the high out of pocket cots of medications. The DOH must report the recommendations or a summary of the discussions to the legislature by December 1, The State Health officer will lead the taskforce. Participants may include patient groups, insurance carriers, pharmacists, pharmacy benefit managers, pharmaceutical companies, prescribers, hospitals, the Office of the Insurance Commissioner, the Health Care Authority and other purchasers, the Office of Financial Management, unions, a Taft-Hartley Trust, a business association, and biotechnology representatives. NOTE: The bill in its original form did not include pharmacists in its list of possible participants on the taskforce. The WSPA/LRAC successfully amended the bill to include a pharmacist AND a representative from a pharmacy benefit manager. 90 Days : SENATE PASSED: 49-0 HOUSE PASSED: GOVERNOR VETOED NOTE: The Washington State Legislature convened its special session and during the special session they successfully took action to override the Governor s veto of the bill ST SPECIAL SESSION SENATE OVERRODE GOVERNOR S VETO: 41-2 HOUSE OVERRODE GOVERNOR S VETO: SB 6421 Epinephrine autoinjectors Signed into law Prescribing health care practitioners may prescribe epinephrine autoinjectors to restaurants, recreation camps, youth sports leagues, amusement parks, colleges, universities, and sports arenas. These entities or organizations may acquire

8 and stock a supply of epinephrine autoinjectors if they are stored in an area that is accessible in an emergency and in accordance with manufacturer instructions and Department of Health (DOH) requirements. Employees of an entity or organization must complete a training program before they are able to administer an epinephrine autoinjector. The entity or organization and its employees are not liable for damages due to use of an epinephrine autoinjector as long as their acts do not constitute gross negligence, willful or wanton misconduct. DOH will be required to develop the required training. Incidents of use of an epinephrine autoinjector must be reported to DOH. DOH must publish an annual report that summarizes use of epinephrine autoinjectors by entities or organizations. June 9, 2016 : SENATE PASSED: 48 0 HOUSE PASSED: 96 1 SB 6238 Prescribing Non-narcotic Schedule II Signed into law March 30, 2016 Schedule II amphetamines or non-narcotic stimulants may be prescribed for any disease state or condition for which the United States Food and Drug Administration has approved an indication. June 9, 2016 : SENATE PASSED: 49-0 HOUSE PASSED: 94-3