BILL ANALYSIS Ó SB 447 Page 1 Date of Hearing: July 7, 2015 ASSEMBLY COMMITTEE ON HEALTH Rob Bonta, Chair SB 447 (Allen) - As Amended June 1, 2015 SENATE VOTE: 27-4 SUBJECT: Medi-Cal: clinics: drugs and supplies. SUMMARY: Revises the Medi-Cal and Family Planning, Access, Care, and Treatment (Family PACT) reimbursement formula for drugs and supplies dispensed by specified clinics. Specifically, this bill: 1)Defines "cost" as the sum of the actual acquisition cost of a drug or supply plus a clinic dispensing fee, for the purposes of reimbursement by the Department of Health Care Services (DHCS) to specified clinics for drugs and supplies covered under the Medi-Cal program and Family PACT Waiver Program. 2)Requires the actual acquisition cost of a drug or supply to be calculated at least once a year. 3)Defines the clinic dispensing fee as the difference between the actual acquisition cost of a drug or supply and the Medi-Cal reimbursement rate. Removes caps to clinic dispensing fees. SB 447 Page 2 4)Requires the reimbursement provided by DHCS to be equal to the amount billed or the Medi-Cal reimbursement rate, whichever is less. 5)Clarifies that clinics designated as federally qualified health centers and rural health clinics are authorized to bill and be reimbursed upon electing to be reimbursed for pharmaceutical goods and services on a fee-for-service basis that are specifically delivered through their dispensaries. EXISTING LAW: 1)Establishes the Medi-Cal program under the direction of DHCS to provide low-income qualifying individuals health care and a uniform schedule of benefits. 2)Establishes the Family PACT program under the direction of the Office of Family Planning to provide eligible low-income individuals comprehensive family planning services. 3)Requires licensed community clinics, free clinics, and intermittent clinics (clinics) to bill and be reimbursed for drugs and supplies covered under the Medi-Cal program and Family PACT Waiver Program at either cost or the clinic's usual charge made to the general public, whichever is less. SB 447 Page 3 4)Defines "cost" as both of the following: a) An amount equal to the sum of the actual acquisition cost of a drug or supply plus a clinic dispensing fee which does not exceed $12 per billing unit, as defined; and, b) The actual acquisition cost for that drug plus a clinic dispensing fee, not to exceed $17 per prescription, for a take-home drug that is dispensed for use by the patient within a specific timeframe of five days or less from the date medically indicated. 5)Requires the reimbursement to be the Medi-Cal reimbursement rate or the amount billed, whichever is less, and for reimbursement to not exceed the net cost of these drugs or supplies when provided by retail pharmacies under the Medi-Cal program. 6)Prohibits DHCS from subjecting a clinic to reimbursement reductions based on a clinic's usual charge to the general public, if a clinic either: a) furnishes services free of charge; b) furnishes services at a nominal charge, as defined by federal law; or, c) can demonstrate, upon request, that it serves primarily low-income patients, and its customary practice is to charge patients based on their ability to pay. 7)Authorizes clinics designated as federally qualified health centers or rural health clinics to bill and be reimbursed if they choose to be reimbursed for pharmaceutical goods and services on a fee-for-service basis. 8)Requires a clinic that is eligible to, but has not chosen to, utilize drugs purchase under the federal drug discount program SB 447 Page 4 (340B Discount Drug Program) for its Medi-Cal patients, to provide notification to the federal Health Resources and Services Administration's Office of Pharmacy Affairs that it is using non-340B drugs for its Medi-Cal patients in the manner and to the extent required by federal law. FISCAL EFFECT: According to the Senate Appropriations Committee, increased annual costs of at least $6 million (General Fund (GF)) and $19 million (federal funds) per year to pay increased reimbursement rates for drugs covered by Medi-Cal. Would modify the existing statutory limits on Medi-Cal reimbursement for drugs dispensed by certain clinics. In doing so, this bill will increase the payment rates by the state for certain drugs. The cost estimates above are based on 2013-14 expenditures for contraceptive drugs and drugs covered under the Medi-Cal and Family PACT program for contraceptive drugs and drugs related to family-planning services. Because this bill does not specifically limit the increased reimbursement to those types of drugs, it is possible that actual costs could be lager. Minor administrative costs to revise existing payment rules and procedures by DHCS (GF and federal funds). COMMENTS: 1)PURPOSE OF THIS BILL. According to the author, California's 1152 community health clinics offer a unique option for low-income patients to receive quality, affordable medical care. The author contends clinics that dispense medication onsite provide the additional convenience of allowing patients to leave their health care provider with medication in hand. The author maintains that this has led to improved access to health care and better patient health outcomes. The author SB 447 Page 5 explains the current billing system the clinics must use is overly complex and leads to numerous billing errors which require staff resources for both the clinics and the state. The author states these errors can take months to resolve and chronically deny clinics the fees to which they are entitled. The author points to existing law, stating community clinics are currently allowed to receive a dispensing fee in addition to the purchasing cost of the medications they dispense to Medi-Cal and Family PACT patients, which enables and encourages clinics to dispense medication onsite. The author states the original intent of the statutes related to clinic dispensing fees was for clinics to recover the cost of storing and dispensing the drugs and to provide clinics with funds to either expand services or increase the number of patients they could serve. The author contends further clarity is needed to define cost in existing law; in some cases clinics are only reimbursed for the purchasing cost of a drug and without any additional funds to cover the overhead needed to store the drug or pay a provider to dispense it to patients. The author concludes this bill will clarify the obligation of DHCS to provide a reasonable dispensing fee and specifically set that fee. 2)BACKGROUND. a) Physician-administered drugs. A physician-administered drug is any covered outpatient drug provided or administered to a recipient, and billed by a provider other than a pharmacy. Such providers include, but are not limited to, physician offices, clinics, and hospitals. A covered outpatient drug is broadly defined as a drug that may be dispensed only upon prescription, and is approved for safety and effectiveness as a prescription drug under the Federal Food, Drug and Cosmetic Act. Physician-administered drugs include both injectable and non-injectable drugs. SB 447 Page 6 AB 2151 (Jackson), Chapter 2051, Statutes of 2004, provided a dispensing fee through Medi-Cal and Family PACT for physician-administered drugs dispensed by a community clinic, a free clinic or an intermittent clinic. Prior to the enactment of AB 2151, Medi-Cal regulations prohibited a dispensing fee or mark-up for take-home drugs dispensed by a clinic. The reimbursement provisions of AB 2151 were modified the following year by AB 77 (Frommer), Chapter 503, Statutes of 2005. Drugs reimbursed under these provisions are typically birth control medication (oral contraception, emergency contraception and birth control patches and rings) and antibiotics. b) 340B drug pricing program. The 340B Drug Pricing Program is a federal program that requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices. The 340B Program enables covered entities to stretch federal resources as far as possible, reaching more eligible patients and providing more comprehensive services. The program provides access to reduced price prescription drugs to over 16,869 health care facilities (as of October 2011) certified by the U.S. Department of Health and Human Services as covered entities. These clinics, centers, and hospitals in turn serve more than 10 million people in all 50 states, plus commonwealths and territories. c) Clinic reimbursements. Under existing law, clinics bill at the lower of cost or the usual charge to the public. "Cost" is defined to include a maximum dispensing fee amount per unit of $12 (an example of a SB 447 Page 7 unit would be calendar month's supply). There is a separate maximum dispensing fee amount of $17 for emergency contraception. Existing law also requires DHCS to reimburse at the lower of the amount billed or the Medi-Cal reimbursement rate, except that reimbursement cannot exceed the net cost of these drugs or supplies when provided by retail pharmacies under the Medi-Cal program. The sponsor of this bill (Planned Parenthood Affiliates of California PPAC)) indicates this bill deletes the reference to the retail pharmacy cap as DHCS has not implemented this cap. The acquisition cost can vary by the type of clinic purchasing (for example, some clinics may receive volume discounts from drug manufacturers). Dispensing fees vary by the type of drug or supply, but not by type of clinic. Under this bill, the clinic dispensing fee is defined as the difference between the actual acquisition cost of a drug or supply and the Medi-Cal reimbursement rate. 3)SUPPORT. PPAC, the sponsor of this bill, state this bill will streamline the process that community clinics use to bill and be reimbursed for medications that are dispensed onsite. The sponsor maintains the current reimbursement process is complicated and often takes month or years to complete, leaving Planned Parenthood health clinics with millions of dollars in outstanding reimbursements owed to them. The sponsor contends that maintaining a reimbursement system that denies clinics a reasonable dispensing fee undermines the ability of clinics to provide quality, low cost care to patients who need it. The sponsor concludes this bill will simplify the existing reimbursement system by setting the dispensing fee at the difference between the acquisition cost and the Medi-Cal reimbursement rate, allowing clinics to bill and be reimbursed at one rate. SB 447 Page 8 Supporters of this bill state California's community clinics and health centers offer a unique option for low-income patients to receive quality, affordable medical care. Supporters contend clinics that dispense medication onsite provide patients with the added convenience of leaving their health care provider with their medication in hand, which removes barriers to care, increases access to care, and improves health outcomes. Supporters state this bill will help provide consistent and equitable reimbursement to clinics for the health care services they provide, and reduce the administrative burden clinics face when dispensing medication. 4)PREVIOUS LEGISLATION. a) AB 2340 (Garcia) of 2014 was gutted and amended last year in the Senate Health Committee with the contents of the introduced version of this bill, but was never heard. b) SB 77 revises the reimbursement formulary for federally qualified health centers and rural health clinics. c) AB 2151 establishes the reimbursement formulary for community care clinics, free clinics, and intermittent clinics that dispense prescription drugs in the Medi-Cal and Family PACT program, including a dispensing fee for physician-administered drugs. REGISTERED SUPPORT / OPPOSITION: Support SB 447 Page 9 Planned Parenthood Affiliates of California (sponsor) California Primary Care Association Community Action Fund of Planned Parenthood of Orange and San Bernardino Counties Community Clinic Association of Los Angeles Planned Parenthood Action Fund of the Pacific Southwest Planned Parenthood Action Fund of Santa Barbara, Ventura, and San Luis Obispo Counties, Inc. Planned Parenthood Advocacy Project Los Angeles County Planned Parenthood Mar Monte Planned Parenthood Northern California Action Fund Planned Parenthood Pasadena and San Gabriel Valley Opposition None on file. Analysis Prepared by:An-Chi Tsou / HEALTH / (916) 319-2097 SB 447 Page 10