首頁供應商& 合作夥伴有關 Medi-Cal 藥物回扣的常見問題​​ 

有關加州醫療補助健康保健計劃藥物回扣的常見問題​​ 

一般問題​​ 

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.​​ 

補充回贈是否需要繳付利息費用？​​      

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:​​ 

  • 如果在發票郵戳日起 38 天內沒有收到補充款項，則按 CMS 利率（每週聯邦庫務票據利率）計算的利息將到期。​​ 
  • 如果在發票郵戳日起計 69 天內沒有收到額外付款，CMS 利率將加入 10 個百分點的利息罰款。 利息和 10% 罰款繼續累積，直到付款郵戳日期為止。​​ 

我是否會收到額外回贈的單獨發票？​​    

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.​​ 

加州/聯邦法律中關於藥品回扣專案的聯邦和州法律有哪些？​​     

聯邦法律：​​ 

《社會保障法》第 1927 條 [第 42 條美國第 1396r-8 條] (a)​​  

與醫療補助 (加州醫療補助健康保健計劃) 藥物回扣專案相關的聯邦立法。 請瀏覽社會保障網頁以獲取更多信息。​​ 

國家法律：​​ 

  • 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.​​ 

醫療服務署藥物回扣專案涉及哪些類型的專案？​​ 

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”?​​   

醫療保健通用程序編碼系統(HCPCS) 是由聯邦醫療保險和醫療補助服務中心(CMS) 開發的全國性統一編碼結構，旨在標準化用於處理聯邦醫療保險和醫療補助(加州醫療補助健康保健計劃)的編碼系統畫）以國家為基礎的主張。​​ 

醫生管理藥物索償需要 HCPCS 代碼來識別程序並確定退款給提供者的金額。 此外，所有醫生服用藥物（PAD）索償都必須包含國家藥物法規（NDC），以便藥品製造商可以向藥品製造商收取回贈的發票。 DHCS 還要求填充 340B 購買藥品的索賠包含「UD」修飾符，這會從藥品製造商的藥品回扣發票中刪除該索賠。​​ 

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.​​ 

有多少個 COH？​​    

有六個 COHS 計劃涵蓋 22 個縣。​​ 

  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.​​ 

醫療補助計劃豁免，用於針對州立專用 CCS 和 GHPP 使用藥物回贈，已於 31 月 2020 到期。由於未為 CCS 和 GHPP 人群提供聯邦資金，DHCS 不再有權為這些計劃發票和收取聯邦醫療補助藥物回贈的權力。截至 2021 年第一季，CCS 和 GHPP 發票已從發票中撤回。​​ 

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.​​ 

什麼是 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.​​  

加州的藥房索賠報銷率是多少？​​    

對於服務日期在 2017 年 4 月 1 日或之後的藥房索賠有效，加州醫療補助健康保健計劃根據實際採購成本 (AAC) 加上專業配藥費或通常和慣例費用中的較低者進行報銷。 AAC 被確定為以下內容中的最低​​ 

  • 國家平均藥物採購成本（NADAC），或如果 NADAC 不可用，批發採購成本（WAC）+ 0%，​​ 
  • 聯邦上限 (FUL)，或​​ 
  • 最大允許成分成本（MAIC）。​​ 

加州配藥時的最大供應天數是多少？​​    

加州對大多數藥物都有 100 天的最大供應量。 這與其他許多擁有最多 30 天供應量的州不同。 爭議使用率時，要考慮 100 天的最大供應量很重要。​​ 

為什麼加州醫療補助健康保健計劃以如此低的費率補償某些提供者？​​      

由於某些提供者並不包含所有信息，因此退還的美元並不總是指出了多少單位（片劑，毫克，小瓶等）的最佳指標。​​ 

其他健康保險或第三方責任 (TPL) 資訊有時不包含在加州醫療補助健康保健計劃索賠中。 看到供應商僅對共付款的退款是正常的（即： 5 美元，15 美元，30 美元等），沒有任何 TPL 數據。 因此，大多數退款金額較低的索償都是正確的，而回扣發票的單位也是正確的。​​ 

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.​​ 

正常的處方法是否會有所不同和/或被取代？​​   

是的。 治療授權請求 (TAR) 可用於推翻正常的處方做法（即 一個受益人一次處方超過六種處方，分配數量超過一般，藥物不在合約藥物名單上的藥物等）​​ 

為什麼我需要提交特定 NDC 的平均製造商價格 (AMP) 資料？​​    

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.​​ 

加州的平均製造商定價 (AMP) 數據何時到期？​​     

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?​​   

貼標商應注意，如果他們連續兩個季度不提交數據，他們的加州補充 AMP 合約可能會被終止或在當前合約到期時不再續約。 如果沒有有效的合同，DHCS 只能透過事先授權才能提供貼標商的藥物。​​ 

如何提交 AMP 資料？​​ 

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 變更該怎麼辦？​​    

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 資料是否提交錯誤（例如： 格式，缺少數據等）？​​ 

如果提交的 AMP 數據發生問題，Gainwell 或藥物回贈分析師將與標籤人聯繫。​​ 

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

請聯絡您的 DHCS 藥品退稅分析師或讓您的政府代表聯絡藥局藥品合約部門。​​ 

提供者俱備什麼資格才能成為加州的公共衛生服務 (PHS) 實體並有資格享受 340B 定價？​​     

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.​​  

提供者是否需要確定加州醫療補助健康保健計劃受益人收到 340B 購買藥品的索賠？​​    

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”?​​   

電子轉賬 (EFT) 付款選項允許註冊用戶在無需提交傳統紙張支票的情況下以電子方式支付藥物回贈發票。此自願選項要求參與者在提交電子數據時遵守特定格式。有關如何註冊 EFT 的更多信息，請聯繫藥品回贈分部電子郵件：drugrebatebranch@dhcs.ca.gov。​​ 

What is “EIS”?​​    

電子介面系統 (EIS) 允許訂閱藥品製造商根據回贈發票檢索當前季度發票，並下載 10 年的索償信息。有關如何獲取該系統的更多信息，請聯繫藥品回贈分支門戶網站團隊：drugrebateportal@dhcs.ca.gov。​​  

從 EIS 系統開立索償​​ 

儲存付費索償資料連結後，請使用 7-Zip 將資料提取為可轉換為 Excel 檔案的文字格式。​​   

如果標籤員有已終止的 NDC，則通知程序是什麼？​​    

如果 NDC 終止，標籤商必須向 CMS和第一資料庫 (FDB) 報告終止日期，以確保加州醫療補助健康保健計劃規定文件擁有最新資訊。​​ 

CMS 將退款的終止日期定義為：​​ 

  • 日期產品已從藥房架上移除；或​​ 
  • 最後一批出售的保質期日期（最後可出售日期）​​ 

藥品製造商須在終止日期後的四季度報告終止藥物的定價信息。​​ 

由管理護理組織提交的索償是否需要退款？​​   

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.​​ 

是否需要將 ROSI 和/或 PQAS 一併提交標籤人的回贈金？​​    

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.​​ 

醫療保健服務部
會計部門
加州醫療補助健康保健計劃​​ 

藥物回贈應收帳款 MS 1101
​​ 

郵政信箱 997415​​ 

加利福尼亞州薩克拉門托 99-7415​​ 

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.​​ 

     有多少受益者參加了加州的Medi-Cal Managed Care ？​​  

有關管理式醫療資訊（包括註冊資料），請造訪Medi-Cal Managed Care網頁。​​ 

加州是否要求藥品製造商為化合物索賠支付回扣？​​   

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 ​​