BILL ANALYSIS Ó SENATE COMMITTEE ON HEALTH Senator Ed Hernandez, O.D., Chair BILL NO: SB 1301 AUTHOR: Hernandez AMENDED: March 29, 2012 HEARING DATE: April 11, 2012 CONSULTANT: Moreno SUBJECT : Prescription drugs: 90-day supply. SUMMARY : Permits a pharmacist to dispense up to a 90-day supply of a drug, other than a controlled substance, pursuant to a prescription that specifies the initial dispensing of a lesser amount followed by periodic refills of that amount if certain requirements are met. Existing law: 1.Provides for the practice of pharmacy and the licensing and regulation of pharmacies and pharmacists by the Board of Pharmacy within the Department of Consumer Affairs. 2.Specifies certain requirements regarding the dispensing and furnishing of dangerous drugs and devices, and prohibits a person from furnishing any dangerous drug or device except upon the prescription of a physician, dentist, podiatrist, optometrist, or veterinarian. 3.Prohibits a prescription for any dangerous drug or dangerous device from being refilled except upon authorization of the prescriber, as specified. 4.Permits a prescription for a dangerous drug or dangerous device to be refilled without the prescriber's authorization if the prescriber is unavailable to authorize the refill and if, in the pharmacist's professional judgment, failure to refill the prescription might interrupt the patient's ongoing care and have a significant adverse effect on the patient's well-being. Permits the prescription to be filled only after making every reasonable effort to contact the prescriber. Requires the pharmacist to inform the patient and the provider that the prescription was refilled under this circumstance. This bill: 1.Permits a pharmacist to dispense up to a 90-day supply of a dangerous drug other than a controlled substance pursuant to a Continued--- SB 1301 | Page 2 valid prescription that specifies the initial dispensing of a lesser amount followed by periodic refills of that amount if : a. The total quantity of dosage units dispensed does not exceed the total quantity of dosage units authorized by the prescriber on the prescription, including refills; b. The prescriber has not specified on the prescription that dispensing the prescription in an initial amount followed by periodic refills is medically necessary; and c. The pharmacist is exercising his or her professional judgment. 2.Prohibits anything in this bill from being construed to require a health care service plan, health insurer, workers' compensation insurance plan, pharmacy benefits manager (PBM), or any other person or entity, including, but not limited to, a state program or state employer, to provide coverage for a dangerous drug in a manner inconsistent with a beneficiary's plan benefit. FISCAL EFFECT : This bill has not been analyzed by a fiscal committee. COMMENTS : 1.Author's statement. According to the author, the cost of a filled prescription is based on the "Product Cost + Dispensing Cost." For each trip to the pharmacy, the patient must not only pay for the additional product but also the other costs that are associated with dispensing that drug. The author states that paying for the professional services of a pharmacist and pharmacy technicians only once, rather than three times, allows the payer and patient to accrue significant savings. A patient that visits the pharmacy every month to refill a maintenance prescription creates higher health care costs because repeat visits cost more than a single visit. Additionally, patient non-compliance with their prescription drugs drives up health care costs. Failure to take prescribed medications can lead to deterioration of the patient's health, which, in turn, leads to higher-cost medications or medical interventions. By 2014, there will be 6 million more Californians insured. As more Californians become insured, we must ensure patients have access to care and reduce overall health care costs for chronic conditions. SB 1301 is a simple effort toward increasing consumer access to health care and local pharmacists. 2.PBMs and mail-order pharmacies. Increasing numbers of SB 1301 | Page 3 employers, labor unions, and managed care companies (collectively, "plan sponsors") that offer prescription drug insurance coverage often hire PBMs to manage these benefits. According to a 2005 Federal Trade Commission study of PBMs, they use mail-order pharmacies to manage prescription drug costs. Many PBMs also own their own mail-order pharmacies. Plan sponsors often encourage patients with chronic conditions who require repeated refills to seek the discounts that 90-day prescriptions and high-volume mail-order pharmacies can offer. As medication prices continue to rise faster than inflation, one method to control pharmacy benefit costs is for health plans and PBMs to offer 90-day supply coverage which reduces costs via a decrease in dispensing fees and potentially increases adherence, according to an article in the American Journal of Health-System Pharmacy titled "Ninety-day versus thirty-day drug dispensing systems." The authors concluded that dispensing less expensive drugs for 90 days rather than 30 days to patients with chronic diseases would result in significant cost savings without compromising safety, despite the possibility of increased waste when drugs are discontinued. 3.Other states. According to the sponsor of this bill, the California Retailers Association (CRA), 20 states have varying statutes that in some way permit 90-day dispensing (Alaska, Arizona, Colorado, Florida, Hawaii, Idaho, Illinois, Kentucky, Main, Michigan, Montana, Nebraska, New York, North Carolina, Rhode Island, South Carolina, South Dakota, Texas, Vermont, and Wyoming). For example, New York mandates that if a health plan or insurer offers a 90-day supply through a mail-order pharmacy, the enrollee can obtain the same supply at a retail pharmacy, provided the pharmacy accepts the same contractual terms and conditions as the mail-order pharmacy. Indiana has legislation pending on the Governor's desk that permits 90 days' worth of medication upon the request of the patient if the patient has completed an initial 30-day supply of the drug. However, a pharmacist is required to notify the prescriber of the change in the quantity filled and comply with state and federal laws and regulations concerning the dispensing limitations concerning a prescription drug. 4.Double referral. This bill is double referred. Should it pass out of this committee, it will be referred to the Senate Committee on Business, Professions and Economic Development. 5.Support. According to CRA and the National Association of Chain Drug Stores (NACDS), a single chain drug store makes SB 1301 | Page 4 approximately 4.5 million calls a month to get authorization to dispense a prescription refill in excess of a 30-day supply. CRA and NACDS state that because physicians are typically busy and unable to take these calls, consumers end up either having to wait for authorization or they end up settling for the 30-day supply, leaving before the physician calls back. CRA, NACDS, and Aging Services of California (ASC) write that not only are these calls burdensome to the physicians and pharmacists, the patient is ultimately inconvenienced and will need to return to the pharmacy two additional times and pay two additional co-payments that he or she would have saved under this proposal. ASC further states that by allowing a 90-day supply, this bill will make it easier for patients to adhere to their treatment, live healthier lives and lower costs throughout the health care system. The County of Los Angeles contends that this bill will increase access to needed medications and improve the health of many County residents with chronic health conditions that are easily controlled with prescribed medications. BIOCOM writes that this bill will likely reduce missed dosages and increase dosage compliance by patients by allowing them to have to refill prescriptions less often, and could reduce total prescription costs by reducing the number of pharmacy visits. 6.Support if amended. The California Medical Association (CMA) is concerned that this bill could weaken the physician's ability to monitor a patient's progress and, if necessary, modify the patient's drug regimen. By eliminating refills, physicians would lose a valuable tool often used to monitor the progress of their patient's treatment. CMA additionally states that, while this bill does not apply to controlled substances, there are still other dangerous drugs that aren't on the controlled substance list that can still be very hazardous to the patient if dispensed improperly and misused. CMA is asking for amendments to ensure physician autonomy over the amount of drugs prescribed. 7.Oppose unless amended. The California Psychiatric Association (CPA) writes that from a psychiatric physician standpoint, many psychiatric medications are toxic or lethal, and that potential is increased significantly when a patient presents with suicidal ideation. The CPA would prefer that the primary thrust of this bill provide that physicians have the ability to "opt in" to this measure, and failing that, exempting psychotropic medications, prescribed by any physician of any SB 1301 | Page 5 specialty or subspecialty, from the provisions of this bill. 8.Amendments. The author intends to amend the bill as follows: On page 2, delete lines 3 through 18 and insert: 4064.5 (a) A pharmacist may dispense not more than a ninety (90) day supply of medication pursuant to a valid prescription that specifies the initial dispensing of a lesser amount followed by periodic refills of that amount if the patient has completed an initial thirty (30) day supply of the drug therapy and all of the following requirements are satisfied: (1) The total quantity of dosage units dispensed does not exceed the total quantity of dosage units authorized by the prescriber on the prescription, including refills. (2) The prescriber has not specified on the prescription that dispensing the prescription in an initial amount followed by periodic refills is medically necessary. (3) The pharmacist is exercising his or her professional judgment. (b) A pharmacist dispensing pursuant to this section shall notify the prescriber of the change in the quantity filled. (c) This section does not apply to psychotropic medication, as defined in Welfare and Institutions Code Section 369.5 (d). SUPPORT AND OPPOSITION : Support: California Retailers Association (sponsor) Aging Services of California BIOCOM California Healthcare Institute Los Angeles County Board of Supervisors National Association of Chain Drug Stores Three individuals Oppose: California Psychiatric Association (unless amended) -- END --