家供应商和合作伙伴关于加州医疗补助计划 (Medi-Cal) 药品回扣的常见问题​​ 

关于 Medi-Cal 药品退款的常见问题​​ 

常见问题​​ 

What are “Medi-Cal” rebates?​​   

“Medi-Cal” rebates are California’s federal Medicaid rebate programs. Medi-Cal is California’s health program which provides free or low-cost health coverage for California residents who meet eligibility requirements. Drug manufacturers are required to pay a rebate for all outpatient drugs that are dispensed and paid for by the State’s Medi-Cal program. Invoicing for drug rebates began January 1, 1991 and continues today​​ 

What are “Medi-Cal supplemental” rebates?​​   

“Medi-Cal supplemental” rebates are additional rebates drug manufacturers have agreed to pay the state. Supplemental rebates are based on the same utilization as the federal rebate program. Drug manufacturers that have agreed to pay supplemental rebates are included on the State’s Contract Drug List (CDL). Generally, these products are not subject to prior authorization. The Pharmacy Benefit’s Drug Contracting Branch is responsible for managing the program and negotiating contracts. Supplemental rebates are required for all federal programs except for utilization from managed care organizations (MCOs). Supplemental rebates have been part of the California rebate program since 1991. Prior to 1997, supplemental rebates were calculated as a percentage of Average Manufacturer Price (AMP) on all covered drugs. However since 1997, contracts are negotiated on specific drugs. California currently has two types of supplemental contracts: Net Cost and AMP. Supplemental contracts pertain to all rebate programs except for managed care organizations (MCO) that became rebate eligible in 2010.​​ 

补充返利是否需要收取利息？​​      

Yes. Section 14105.33 of the Welfare & Institutions Code was amended in 1997 allowing state supplemental contracts to include interest and penalty provisions. Contracts include the following:​​ 

  • 如果在发票邮戳日起 38 天内仍未收到补充付款，则应按 CMS 利率（每周联邦国库券利率）计算利息。​​ 
  • 如果在发票邮戳日起 69 天内未收到补充付款，则会在 CMS 利率上增加 10 个百分点的利息罚款。 利息和 10% 的罚款将持续累积，直到付款的邮戳日为止。​​ 

我是否会收到单独的补充退款发票？​​    

Yes. Beginning 4th quarter 2001, DHCS began sending labelers separate supplemental invoices. Prior to October 2001, labelers were instructed to calculate the supplemental rebate using their Medi-Cal invoice.​​ 

关于加州/联邦法律的药品回扣计划的联邦和州法律是什么？​​     

联邦法律：​​ 

社会保障法第 1927 条 [42 USC 1396r-8] （a）​​  

与医疗补助（加利福尼亚州的 Medi-Cal）药品回扣计划相关的联邦立法。 请访问社会保障网页以了解更多信息。​​ 

国家法律：​​ 

  • Welfare and Institutions (W&I) Code Section 14105. Contains information on the Medi-Cal Drug Rebate Program.​​ 
  • Senate Bill 391, 1997 Amended W & I Code 14105.33. Authorized the State to charge interest and a penalty for late state supplemental rebate payments. (Effective date 10/1/97)​​ 

To Access W & I Code, visit the California Legislative Information website, and select the button labeled “California Law,”  then select Welfare and Institutions Code. Next enter a section, select the “Enter” button to search.​​ 

卫生保健服务部药品回扣计划涉及哪些类型的计划？​​ 

California invoices drug manufacturers for all federal Medicaid programs, including those incorporated by waiver. In addition, manufacturers receive supplemental invoices if they have entered into a contract with the State. Programs for which rebates are due include: Medi-Cal (FFS, COHS, Managed Care Organizations (MCOs)), CCS/Healthy Families, GHPP, Blood Factors, FPACT and BCCTP. Separate invoices are mailed for pharmacy, PADs and compound claims for many of the programs.​​ 

What is “FPACT”?​​      

Family Planning, Access, Care, and Treatment (FPACT) was a State-only program until December 1, 1999 when CMS approved California’s 1115 waiver. As a result, the program became eligible for Title XIX funding. Effective 4Q1999, the State began invoicing for rebates. With the approval of the waiver, the FPACT program also became eligible for supplemental rebates. The Department of Health Care Services submitted a State Plan Amendment (SPA) to transition the current FPACT waiver into the Medi-Cal State Plan. The SPA was approved on March 24, 2011 by CMS. As approved by CMS, the SPA transitioned the FPACT waiver into the State Plan with a retroactive effective date of July 1, 2010. Additional information is available on the FPACT program webpage.​​ 

What is a “Physician Administered Drug (PAD)”?​​      

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.​​ 

What is “HCPCS”?​​   

医疗保健通用程序编码系统 (HCPCS) 是由医疗保险和医疗补助服务中心 (CMS) 开发的全国统一编码结构，用于在全国范围内标准化处理医疗保险和医疗补助 (Medi-Cal) 索赔所使用的编码系统。​​ 

医生管理的药物索赔需要 HCPCS 代码来识别程序并确定偿还提供者的金额。 此外，所有医生管理药品 (PAD) 索赔都必须包含国家药品代码 (NDC)，以便药品制造商能够开具退款发票。 DHCS 还要求填写 340B 购买药品的索赔中包含“UD”修饰符，这会将索赔从药品制造商的药品回扣发票中删除。​​ 

What is “FPACT HCPCS”?​​     

FPACT HCPCS are Family Planning Access Care and Treatment (FPACT) Physician Administered Drug (PAD) claims. These are claims from non-pharmacy providers. Usually the claim is submitted by a clinic, but not always. The claim requires a HCPCS code, the NDC and a “UD” modifier if filled with a 340B purchased drug.​​ 

What is a “COHS”?​​     

County Organized Health Systems (COHS) is a non-profit, independent public agency that contracts with the State to administer Medi-Cal benefits through local care providers and/or Health Maintenance Organizations. COHS have been part of the Medi-Cal program since CMS approved the first COHS plan in 1983. COHS have been part of the rebate program since 1991 and invoiced separately since fourth quarter 2001.​​ 

有多少个 COHS？​​    

有 6 个 COHS 计划覆盖 22 个县。​​ 

  1. “CalOPTIMA” – Orange County​​ 
  2. “Central California Alliance for Health” – Santa Cruz, Monterey and Merced counties​​ 
  3. “Health Plan of San Mateo” – San Mateo County​​ 
  4. “Partnership Health Plan” – Napa, Solano, Yolo, Sonoma, Marin, Mendocino, Del Norte, Humboldt, Lake, Lassen, Modoc, Shasta, Siskiyou and Trinity counties.​​ 
  5. “CenCal” – Santa Barbara and San Luis Obispo counties​​ 
  6. “Gold Coast Health Plan” — Ventura County​​ 

What is “CCS/GHPP”?​​     

California Children’s Services (CCS) is a program that treats children with certain physical limitations and chronic health conditions or diseases. The Genetically Handicapped Persons Program (GHPP) is a health program for adults with certain genetic diseases. CMS approved a Medicaid program waiver, effective September 01, 2005, which allowed the State to invoice drug manufacturers for rebates.​​ 

针对仅限州内 CCS 和 GHPP 使用情况收取药品回扣的 Medicaid 计划豁免于 12 月31 、 2020到期。由于联邦政府不再为 CCS 和 GHPP 人群提供资金，DHCS 不再有权为这些项目开具发票并收取联邦医疗补助药品退款。自 2021 年第一季度起，CCS 和 GHPP 发票已从发票中撤销。​​ 

What are “Blood Factors”?​​     

Blood Factors or Factor 8 is an essential blood-clotting protein, also known as anti-hemophilic factor (AHF). DHCS invoices drug manufacturers on separate invoices for drugs that are used to treat blood factor diseases. Providers of AHF drugs are reimbursed at their acquisition cost plus 20 percent.​​ 

什么是BCCTP？​​    

Breast Cancer and Cervical Treatment Program (BCCTP) provides cancer treatment for eligible low-income California residents who are screened by Cancer Detection Program: Every Woman Counts (CDP:EWC) or Family Planning Access Care and Treatment (FPACT) programs and found to be in need of treatment for breast and/or cervical cancer. Assembly bill (AB) 430, (Chapter 171, Statutes of 2001) provided the State with statutory authority to implement the optional federal Breast and Cervical Cancer and Treatment Act of 2000. California’s SPA was approved by the federal government with an effective date of January 1, 2000. Drug manufacturers have been required to pay rebates since the program was included in California’s Medicaid State Plan. Visit the BCCTP webpage for more information.​​  

加州药房索赔的报销率是多少？​​    

对于服务日期在 2017 年 4 月 1 日或之后的药房索赔，Medi-Cal 将根据实际采购成本 (AAC) 加上专业配药费或通常和惯例费用中的较低者进行报销。 AAC 被确定为以下最低值：​​ 

  • 全国平均药品采购成本 (NADAC) 或批发采购成本 (WAC) + 0%（若没有 NADAC），​​ 
  • 联邦上限（FUL），或​​ 
  • 最高允许成分成本 (MAIC)。​​ 

加州配药的最大供应天数是多少？​​    

加州对大多数药品的最大供应量为 100 天。 这与许多其他拥有最高 30 天供应量的州不同。 在对使用情况提出异议时，务必考虑 100 天的最大供应量。​​ 

为什么 Medi-Cal 以如此低的费率报销某些医疗服务提供者？​​      

报销金额并不总是表示配发了多少单位（药片、毫克、小瓶等）药品的最佳指标，因为有些供应商并没有提供所有信息。​​ 

其他健康保险或第三方责任 (TPL) 信息有时不包含在 Medi-Cal 索赔中。 医疗服务提供者仅报销共付费用（即 5 美元、15 美元、30 美元等），没有任何 TPL 数据。 因此，大多数报销金额较低的索赔都是正确的，并且退税发票的单位也是正确的。​​ 

It is typical for managed care organizations (MCOs) to provide either a low reimbursement or no reimbursement amount on the claim. CMS’s Medicaid Drug Rebate Program Notice for Manufacturer’s Release No. 84 addresses the issue of low or no reimbursement for MCO claims. According to CMS, rebates are owed even if the MCO invoice does not show any paid amount since the drug cost is part of the capitated payment made by the State to the MCO. Consequently, reimbursement amount should not be used to dispute utilization since it has no relationship to units.​​ 

正常的处方做法是否会有所变化和/或被推翻？​​   

是的。 治疗授权请求 (TAR) 可用于覆盖正常处方做法（即 同一受益人每次开具的处方超过六张、数量超过通常配药数量、药品不在合同药品清单上等）​​ 

为什么我需要提交某些 NDC 的平均制造商价格 (AMP) 数据？​​    

Only labelers who have an AMP based State Supplemental Drug Rebate Agreement with California need to provide AMP data. The contract requires AMP data to be submitted quarterly so a unit rebate amount (URA) can be calculated for invoice purposes. AMP data must be provided for each NDC for each quarter as required by the terms of the contract.​​ 

加利福尼亚州的平均制造商定价 (AMP) 数据何时公布？​​     

AMP information for each NDC must be submitted to the California Department of Health Care Services (DHCS) fiscal intermediary, Gainwell Technologies, LLC (Gainwell), within 30 days after the end of each quarter. This deadline is the same as CMS’s deadline for the federal drug rebate program.​​ 

What happens if I don’t turn in the AMP data timely?​​   

标签商应该知道，如果他们连续两个季度不提交数据，他们的加州补充 AMP 合同可能会在当前合同到期时终止或不再续签。 如果没有有效合同，DHCS 只能通过事先授权才能提供标签商的药品。​​ 

如何提交 AMP 数据？​​ 

AMP data for Supplemental contracts is submitted to Gainwell. AMP data is due within 30 days after the end of the quarter. Please contact the Drug Rebate Branch at drugrebatebranch@dhcs.ca.gov, for instructions on how to submit AMP data.​​  

如果我的 AMP 发生变化怎么办？​​    

If a labeler’s AMP changes for a period under contract, the labeler must submit that updated AMP to Gainwell. The AMP data is submitted in the same manner as the initial AMP was submitted. Please contact the Drug Rebate Branch at drugrebatebranch@dhcs.ca.gov, for instructions on how to submit AMP data.​​  

如何知道我的 AMP 数据是否提交有误（即 格式、缺失数据等）？​​ 

如果提交的 AMP 数据有问题，Gainwell 或药品回扣分析师将联系标签商。​​ 

What if I can’t find a copy of my state supplemental contract?​​   

联系您的 DHCS 药品回扣分析师或让您的政府代表联系药房药品承包部门。​​ 

什么资格使提供商成为加利福尼亚州的公共卫生服务 (PHS) 实体并有资格享受 340B 定价？​​     

The drug rebate program was amended by the Veterans Health Care Act of 1992 (VHCA). Under the VHCA, Congress created the 340B program which is administered by the federal Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA). The 340B program requires manufacturers of drugs that are paid for by state Medicaid programs to enter into an agreement with HRSA to provide statutory discounts on drugs to “covered entities”. Covered entities are required to identify claims for which the Medicaid beneficiary received a 340B purchased drug. The State is not entitled to rebates for those claims since the covered entity has already received a discount from the drug manufacturer. California’s rebate invoicing system automatically removes pharmacy and Physician Administered Drug (PAD) claims which include the appropriate PHS/340B identifier from the drug manufacturer’s invoice. Information about the 340B program and which entities qualify can be found on the HRSA 340 B Drug Pricing Program webpage.​​  

提供商是否需要识别 Medi-Cal 受益人收到 340B 购买药品的索赔？​​    

Yes. In order to comply with federal law claims must be filled out correctly to prevent “duplicate discounts.” This occurs when the drug manufacturer gives the provider the discounted 340B price and pays a Medicaid rebate. In order to prevent the “duplicate discount”, providers must include the appropriate code on the claim. Physician Administered Drug claims require a “UD” modifier. Pharmacy claims need to have a “08” in the Basis of Cost Determination field. Both the “UD” modifier and the “08” inform DHCS that a 340B purchased drug was used for the claim. Our rebate system removes the claims from the drug manufacturers rebate invoice ensuring that the drug manufacturer is not subject to the “duplicate discount”.​​ 

What is “EFT”?​​   

电子资金转账 (EFT) 支付选项允许注册用户以电子方式支付药品回扣发票，而无需提交传统的纸质支票。此自愿选项要求参与者在提交电子数据时遵守特定格式。请联系药品回扣部门 drugrebatebranch@dhcs.ca.gov，以获取有关如何注册 EFT 的更多信息。​​ 

What is “EIS”?​​    

电子接口系统 (EIS) 允许订阅的药品制造商检索当前季度的发票并下载基于回扣发票的 10 年索赔信息。请联系药品退税分支门户团队 drugrebateportal@dhcs.ca.gov，以获取有关如何访问该系统的更多信息。​​  

从 EIS 系统发起索赔​​ 

保存已付索赔数据链接后，使用 7-Zip 将数据提取为可转换为 Excel 文件的文本格式。​​   

如果标签商的 NDC 已终止，通知流程是什么？​​    

如果 NDC 终止，标签商必须向 CMS和第一数据库 (FDB) 报告终止日期，以确保 Medi-Cal 处方文件具有最新的信息。​​ 

CMS 将折扣终止日期定义为：​​ 

  • 产品从药店货架下架的日期；或​​ 
  • 最后一批售出的产品的保质期（最后可使用日期）​​ 

药品制造商必须报告终止日期后四个季度的终止药品定价信息。​​ 

管理式医疗机构提交的索赔可以获得退款吗？​​   

Yes. Section 2501 of the Affordable Care Act (ACA) amended section 1927(b)(1)(A) of the Social Security Act requires that the manufacturers “provide a rebate …including (for) such drugs dispensed to individuals enrolled with a Medicaid MCO if the organization is responsible for coverage of such drugs.” While section 1927(b)(1)(A) of the Act references payments made under the state plan, the amended statutory language does not limit the provision of additional manufacturer rebates to only drugs for which the MCO incurred a cost. When a drug is dispensed to a Medicaid beneficiary under a managed care arrangement, the state has made a capitated payment to the MCO for the drug. Regardless of the payment terms negotiated as part of the contract between the MCO and its participating providers to provide Medicaid coverage, the manufacturer is responsible for payment of rebates for covered outpatient drugs dispensed to Medicaid beneficiaries enrolled in MCOs. DHCS began collecting rebates for claims with a date of service of March 23, 2010, the implementation date of ACA.​​ 

标签商的退款付款是否需要与 ROSI 和/或 PQAS 一起提交？​​    

Yes. The Centers for Medicare & Medicaid Services (CMS) requires that the Reconciliation of State Invoices (ROSI) and the Prior Quarter Adjustment Statement (PQAS) be included with every rebate payment. Without the ROSI and/or PQAS, the state will not be able to post your rebate payment. The data required on the forms is approved through the federal Office of Management and is mandated by CMS. It is also mandatory that drug manufacturers include ROSI and/or PQAS for any supplemental rebates paid. Submit checks, ROSI, PQAS and other supporting documents to the DHC Accounting address noted on your Invoice Cover Letters.​​ 

卫生保健服务部
会计科
Medi-Cal​​ 

药品回扣应收账款
MS 1101​​ 

邮政信箱 997415​​ 

萨克拉门托，加利福尼亚州 95899-7415​​ 

In order to ensure that payments are processed correctly, it is necessary to consult your Invoice Cover Letter for account information. Separate payments are required for many of the programs.​​ 

     加州有多少受益人参加了 Medi-Cal 管理式医疗？​​  

有关管理式医疗信息（包括登记数据），请访问Medi-Cal 管理式医疗网页。​​ 

加州是否要求药品制造商支付复合索赔的回扣？​​   

Yes. California’s claims processing system has been capturing the information necessary to rebate drug manufacturers for compound rebates since October 2003. To ensure compliance with federal requirements, drug manufacturers will be invoiced for compounds in 2014. Invoicing will be retroactive to 2003 when the claims processing system began capturing the data.​​  

Back to Medi-Cal Drug Rebate ​​