Pharmaceutical wholesale

TopicBill numbersort iconAuthorInterest positionBecame law
An Act to Amend Section 1367.205 Of, to Add Sections 1367.41 and 1367.42 To, and to Add and Repeal Section 1342.71 Of, the Health and Safety Code, and to Amend Section 10123.192 Of, to Add Section 10123.201 To, and to Add and Repeal Section 10123.193 Of, the Insurance Code, Relating to Health Care Coverage. AB 339 (2015-2016) GordonOpposeYes
(1)Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a… More
(1)Existing law, the Knox-Keene Health Care Service Plan Act of 1975, provides for the licensure and regulation of health care service plans by the Department of Managed Health Care and makes a willful violation of the act a crime. Existing law also provides for the regulation of health insurers by the Department of Insurance. Existing law requires a health care service plan or insurer that provides prescription drug benefits and maintains one or more drug formularies to make specified information regarding the formularies available to the public and other specified entities. Existing law also specifies requirements for those plans and insurers regarding coverage and cost sharing of specified prescription drugs. This bill would prohibit the formulary or formularies for outpatient prescription drugs maintained by a health care service plan or health insurer from discouraging the enrollment of individuals with health conditions and from reducing the generosity of the benefit for enrollees or insureds with a particular condition. The bill, until January 1, 2020, would provide that the copayment, coinsurance, or any other form of cost sharing for a covered outpatient prescription drug for an individual prescription shall not exceed $250 for a supply of up to 30 days, except as specified, and would prohibit, for a nongrandfathered individual or small group plan contract or policy, the annual deductible for outpatient drugs from exceeding a specified amount. The bill would make these cost-sharing limits applicable only to covered outpatient prescription drugs that constitute essential health benefits, as defined. The bill would require a plan contract or policy to cover a single-tablet prescription drug regimen for combination antiretroviral drug treatments that are medically necessary for the treatment of AIDS/HIV, as specified. The bill, until January 1, 2020, would require a nongrandfathered individual or small group plan contract or policy to use specified definitions for each tier of a drug formulary. The bill would make related findings and declarations. This bill would require a health care service plan contract or health insurance policy that provides coverage for outpatient prescription drugs to provide coverage for medically necessary prescription drugs, including nonformulary drugs determined to be medically necessary, and, for an insurer, would require copayments, coinsurance, and other cost sharing for outpatient prescription drugs to be reasonable. This bill would make these provisions applicable to nongrandfathered health care service plan contracts or health insurance policies that are offered, renewed, or amended on or after January 1, 2017. (2)Existing law requires every health care service plan that provides prescription drug benefits to maintain specified information that is required to be made available to the Director of the Department of Managed Health Care upon request. This bill would also impose these requirements on a health insurer that provides prescription drug benefits, as provided. The bill would authorize an insurer to require step therapy, as defined, when more than one drug is appropriate for the treatment of a medical condition, subject to specified requirements. The bill, with regard to an insured changing policies, would prohibit a new insurer from requiring the insured to repeat step therapy when that person is already being treated for a medical condition by a prescription drug, as specified. For plan years commencing on or after January 1, 2017, the bill, except as specified, would require a plan or insurer that provides essential health benefits to allow an enrollee or insured to access his or her prescription drug benefits at an in-network retail pharmacy, and would authorize a nongrandfathered individual or small group plan or insurer to charge an enrollee or insured a different cost sharing for obtaining a covered drug at a retail pharmacy, and would require that cost-sharing amount to count towards the plan’s or insurer’s annual out-of-pocket limitation, as specified. This bill, commencing January 1, 2017, would require a plan or insurer to maintain a pharmacy and therapeutics committee that is responsible for developing, maintaining, and overseeing any drug formulary list, as provided. The bill would require the committee to, among other things, evaluate and analyze treatment protocols and procedures related to the plan’s or insurer’s drug formulary at least annually. (3)Existing law requires the Department of Managed Health Care and the Department of Insurance to jointly develop a standard formulary template by January 1, 2017, and requires plans and insurers to use that template to display formularies, as specified. Existing law requires the standard formulary template to include specified information. This bill would require the standard formulary template to include additional specified information, including which medications are covered, including both generic and brand name. (4)Because a willful violation of the bill’s requirements relative to health care service plans would be a crime, this bill would impose a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. Hide
An Act to Amend Section 1385.045 Of, to Add Section 1367.245 To, and to Add and Repeal Chapter 9 (Commencing with Section 127675) of Part 2 of Division 107 Of, the Health and Safety Code, and to Amend Section 10181.45 Of, and to Add Section 10123.204 To, the Insurance Code, Relating to Health Care. SB 1010 (2015-2016) HernandezSupportNo
Existing law, the Knox-Keene Health Care Service Plan Act of 1975 (Knox-Keene Act), provides for the licensure and regulation of health care service plans by the Department of Managed Health Care… More
Existing law, the Knox-Keene Health Care Service Plan Act of 1975 (Knox-Keene Act), provides for the licensure and regulation of health care service plans by the Department of Managed Health Care (DMHC) and makes a willful violation of the act a crime. Existing law also provides for the regulation of health insurers by the Department of Insurance (DOI). Existing law requires health care service plans and health insurers to file specified rate information with DMHC or DOI, as applicable, for health care service plan contracts or health insurance policies in the individual or small group markets and for health care service plan contracts and health insurance policies in the large group market. This bill would require health care service plans or health insurers that file the above-described rate information to report to DMHC or DOI, on a date no later than the reporting of the rate information, specified cost information regarding covered prescription drugs, including generic drugs, brand name drugs, and specialty drugs dispensed as provided. The information reported would include, but not be limited to, the 25 most frequently prescribed drugs and the 25 most costly drugs by total plan or insurer spending. DMHC and DOI would be required to compile the reported information into a report for the public and legislators that demonstrates the overall impact of drug costs on health care premiums and publish the reports on their Internet Web sites by October 1 of each year. Except for the report, DMHC and DOI would be required to keep confidential all information provided pursuant to these provisions. Because a willful violation of the Knox-Keene Act is a crime, this bill would impose a state-mandated local program. This bill, effective January 1, 2018, except as provided, would require a manufacturer of a prescription drug to notify in writing state purchasers, health care service plans, health insurers, and pharmacy benefit managers if it is increasing the wholesale acquisition cost of the drug during any 12-month period by 25% or more based upon the wholesale acquisition cost of the drug and pursuant to a specified schedule, or by more than $10,000. The bill, effective January 1, 2018, would require a manufacturer of a prescription drug to notify in writing, 3 days before the commercial availability of the drug, state purchasers, health care service plans, health insurers, and pharmacy benefit managers if it is introducing a new prescription drug to market at a wholesale acquisition cost of $10,000 or more annually or per course of treatment. The bill would require a manufacturer, within 30 days of notification of a price increase, or notification of the introduction to market of a prescription drug that has a wholesale acquisition cost of $10,000 or more annually or per course of treatment, to report specified information regarding the drug price to the Office of Statewide Health Planning and Development and would require a manufacturer who fails to provide the required information to be subject to an administrative penalty of $1,000 per day for every day after the 30-day notification period. The bill would also require a pharmacy benefit manager that receives notice of a price increase consistent with these provisions to provide notice of the price increase to its contracting public and private purchasers, as provided. The bill would define “pricing information,” as specified, would deem it to be confidential information, as specified, would provide that the information is exempt from disclosure under the California Public Records Act, and would require or authorize, as specified, other entities to disclose the information under a certain condition. The bill would make the Office of Statewide Health Planning and Development the entity charged with implementing and enforcing these provisions and would require that office to publish specified information collected pursuant to these provisions on its Internet Website. The bill would repeal these provisions by January 1, 2022. Existing law requires, for large group health care service plan contracts and health insurance policies, each health care service plan or health insurer to file with DMHC or DOI the weighted average rate increase for all large group benefit designs during the 12-month period ending January 1 of the following calendar year, and to also disclose specified information for the aggregate rate information for the large group market. This bill would add to that disclosure of information for the aggregate rate information for the large group market, the requirement for health care service plans or health insurers to disclose specified information regarding the cost of covered prescription generic drugs but excluding generic specialty drugs, brand name drugs, excluding brand name specialty drugs, and brand name and generic specialty drugs dispensed at a pharmacy, network pharmacy, or mail order pharmacy for outpatient use and regarding the use of a pharmacy benefit manager, as prescribed. Existing constitutional provisions require that a statute that limits the right of access to the meetings of public bodies or the writings of public officials and agencies be adopted with findings demonstrating the interest protected by the limitation and the need for protecting that interest. This bill would make legislative findings to that effect. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. Hide
An Act to Add Section 14105.194 to the Welfare and Institutions Code, Relating to Medi-Cal, and Declaring the Urgency Thereof, to Take Effect Immediately. AB 900 (2013-2014) AlejoSupportNo
Existing law provides for the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services. The… More
Existing law provides for the Medi-Cal program, which is administered by the State Department of Health Care Services, under which qualified low-income individuals receive health care services. The Medi-Cal program is, in part, governed and funded by federal Medicaid Program provisions. Existing law requires, except as otherwise provided, Medi-Cal provider payments to be reduced by 1% or 5%, and provider payments for specified non-Medi-Cal programs to be reduced by 1%, for dates of service on and after March 1, 2009, and until June 1, 2011. Existing law requires, except as otherwise provided, Medi-Cal provider payments and payments for specified non-Medi-Cal programs to be reduced by 10% for dates of service on and after June 1, 2011. This bill would instead require that this payment reduction not apply to skilled nursing facilities that are a distinct part of a general acute care hospital, for dates of service on or after July 1, 2013, subject to necessary federal approvals. This bill would declare that it is to take effect immediately as an urgency statute. Hide
An Act to Add Chapter 5 (Commencing with Section 48800) to Part 7 of Division 30 of the Public Resources Code, Relating to Solid Waste. AB 2139 (2009-2010) ChesbroOpposeNo
The California Integrated Waste Management Act of 1989, administered by the Department of Resources Recycling and Recovery, requires a pharmaceutical manufacturer that sells or distributes medication… More
The California Integrated Waste Management Act of 1989, administered by the Department of Resources Recycling and Recovery, requires a pharmaceutical manufacturer that sells or distributes medication that is self-injected at home through the use of hypodermic needles and other similar devices to submit a plan to the department that describes how the manufacturer supports the safe collection and proper disposal of the waste devices. This bill would create the California Product Stewardship Act and would require the department, by January 1, 2012, in consultation with specified state agencies, to submit a report to the Legislature recommending that one or more consumer products be included as a covered product for purposes of the act. The bill would require a producer of a covered product, one year after the effective date of a statute designating a product as a covered product, or the product stewardship organization created by one or more producers of that covered product to act as an agent on their behalf, to submit a product stewardship plan to the department, which would be required to include specified elements, including performance goals, a collection rate, and product goals. The department would be required to review and either deem the product stewardship plan submitted to the department as complete or incomplete, within 45 days after receiving the plan. The bill would prohibit the producer of a covered product from selling a covered product 6 months after the plan is deemed complete unless the producer or product stewardship organization of the covered product has submitted a plan to the department that is deemed complete by the department. The bill would require the department, 6 months after a plan is deemed complete, and on January 1 and July 1 annually thereafter, to post on its Internet Web site the covered products that are not in compliance and the bill would require a wholesaler or retailer that distributes or sells covered products to monitor the department’s Internet Web site to determine if a covered product is in compliance. The act would require a producer of a covered product to collect the covered product pursuant to the product stewardship plan and to meet the performance goals included in the product stewardship plan. The bill would provide that a product stewardship program is in compliance with the act only if it achieves the collection rate specified in the product stewardship plan. Each producer or product stewardship organization implementing a product stewardship plan would be required to prepare and submit to the department an annual report describing the activities carried out pursuant to the product stewardship plan. A producer or product stewardship organization submitting a product stewardship plan would be required to pay the department an annual fee that would be set by the department. The bill would provide for the imposition of administrative civil penalties upon a producer who does not comply with the act’s requirements. The bill would create in the existing Integrated Waste Management Fund the Product Stewardship Account and would require that the administrative fees be deposited into that account and that the penalties be deposited into the Product Stewardship Penalty Subaccount that the bill would create in that account. The bill would authorize the fees and penalties to be expended, upon appropriation by the Legislature, to cover the board’s program implementation costs and as incentives to enhance recyclability and redesign efforts and to reduce environmental and safety impacts of covered products. Hide