家プロバイダーとパートナーメディカルの薬剤リベートに関するよくある質問​​ 

Medi-Cal Drug Rebatesに関するよくある質問​​ 

一般的な質問​​ 

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.​​ 

追加リベートには利息がかかりますか?​​      

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:​​ 

  • 請求書の消印日から38日以内に追加支払いが受領されない場合は、CMSレート(週次連邦財務省短期証券レート)で計算された利息が支払われます。​​ 
  • 請求書の消印日から69日以内に追加の支払いが受け取られない場合、CMSの利率に10パーセントポイントの利息ペナルティが加算されます。 利息と10%のペナルティは、支払いの消印日まで発生し続けます。​​ 

追加リベートの請求書は別途発行されますか?​​    

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.​​ 

カリフォルニア州/連邦法における薬物リベートプログラムに関する連邦法および州法はどのようなものですか?​​     

連邦法:​​ 

社会保障法第1927条[42 U.S.C. 1396r-8] (a)​​  

メディケイド(カリフォルニア州のMedi-Cal)薬物リベートプログラムに関連する連邦法。 詳細については、社会保障のWebページをご覧ください 。​​ 

州法:​​ 

  • 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.​​ 

Department of Health Care Services Drug Rebate Programにはどのような種類のプログラムが含まれていますか?​​ 

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”?​​   

HCPCS(Healthcare Common Procedure Coding System)は、メディケア・メディケイド・サービスセンター(CMS)が開発した全国統一のコーディング構造で、メディケア・メディケイド(Medi-Cal)の請求を全国的に処理するために使用されるコーディングシステムを標準化しています。​​ 

医師が投与する薬物請求では、手順を特定し、プロバイダーに払い戻す金額を決定するためにHCPCSコードが必要です。 さらに、すべての医師が投与する医薬品(PAD)の請求には、医薬品製造業者にリベートを請求できるように、全米医薬品法(NDC)を含める必要があります。 また、DHCSは、340Bが購入した医薬品で満たされた請求には、「UD」修飾子を含めることを義務付けており、これにより、医薬品メーカーの医薬品リベート請求書から請求が削除されます。​​ 

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.​​ 

COHはいくつありますか?​​    

22の郡をカバーする6つのCOHSプランがあります。​​ 

  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.​​ 

州のみのCCSおよびGHPPの利用に対する薬物リベートを徴収するためのメディケイドプログラムの免除は、2020年12月31日に期限切れになりました。CCSおよびGHPPの人口に対する連邦政府の資金提供が延長されていないため、DHCSは、これらのプログラムに対する連邦メディケイドの医薬品リベートを請求および徴収する権限をもはや持っていません。2021年第1四半期の時点で、CCSおよびGHPPの請求書は請求から取り下げられました。​​ 

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.​​ 

BCCTPとは?​​    

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.​​  

カリフォルニア州の薬局請求の償還率はどのくらいですか?​​    

2017年4月1日以降のサービス日の薬局請求に対して有効となり、Medi-Calは、実際の取得コスト(AAC)に専門家の調剤料、または通常および慣習的な料金のいずれか低い方に基づいて払い戻しを行います。 AAC は、次のうち最も低いものとして決定されます。​​ 

  • 全国平均医薬品取得コスト(NADAC)、またはNADACが利用できない場合は卸売取得コスト(WAC)+ 0%、​​ 
  • 連邦上限 (FUL)、または​​ 
  • 最大許容原材料コスト(MAIC)。​​ 

カリフォルニア州で薬を調剤する際の最大供給日数はどれくらいですか?​​    

カリフォルニア州では、ほとんどの医薬品の最大供給量が100日です。 これは、最大30日間の供給がある他の多くの州とは異なります。 利用を議論する際には、最大供給量100日を考慮することが重要です。​​ 

なぜMedi-Calは一部のプロバイダーにこのような低率で払い戻しを行うのですか?​​      

一部のプロバイダーにはすべての情報が含まれているわけではないため、償還されたドルは、薬物の単位数(錠剤、ミリグラム、バイアルなど)の最良の指標であるとは限りません。​​ 

その他の健康保険または第三者賠償責任(TPL)情報は、Medi-Calの請求に含まれていない場合があります。 プロバイダーが自己負担額(つまり、 5ドル、15ドル、30ドルなど)TPL データはありません。 そのため、払戻額が少ないほとんどの請求は正しく、リベートの請求単位も正確です。​​ 

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.​​ 

通常の処方箋の慣行は異なるか、または上書きされますか?​​   

はい。 治療承認申請(TAR)は、通常の処方箋の慣行(つまり、 受益者1名につき一度に6処方箋を超える処方箋、通常の調剤量より多い量、契約医薬品リストに載っていない医薬品など)​​ 

特定のNDCについて、平均製造業者価格(AMP)データを提出する必要があるのはなぜですか?​​    

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.​​ 

カリフォルニア州の平均メーカー価格(AMP)データはいつ期限が切れますか?​​     

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?​​   

ラベラーは、2四半期連続でデータを提出しない場合、現在の契約の有効期限が切れたときにCalifornia Supplemental AMP契約が終了するか、更新されない可能性があることに注意する必要があります。 有効な契約がない場合、DHCSは事前の承認なしにラベラーの医薬品を利用可能にすることができます。​​ 

AMP データを送信するにはどうすればよいですか?​​ 

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.​​  

AMP が変更された場合はどうなりますか?​​    

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.​​  

AMP データが誤って送信されたかどうか(例: 形式、欠落しているデータなど)?​​ 

Gainwellまたは薬剤リベートアナリストは、提出されたAMPデータに問題がある場合、ラベラーに連絡します。​​ 

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

DHCSの医薬品リベートアナリストに連絡するか、政府の代表者に薬局医薬品契約支店に連絡してもらってください。​​ 

カリフォルニア州の公衆衛生サービス(PHS)事業体としてのプロバイダーの資格と、340Bの価格設定の対象となるものは何ですか?​​     

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.​​  

プロバイダーは、Medi-Calの受益者が340Bの購入薬を受け取る請求を特定する必要がありますか?​​    

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”?​​   

電子資金移動(EFT)支払いオプションを使用すると、登録ユーザーは、従来の紙の小切手を提出することなく、医薬品リベート請求書を電子的に支払うことができます。この任意のオプションでは、参加者は電子データを提出する際に特定の形式に従う必要があります。EFTへのサインアップ方法の詳細については、drugrebatebranch@dhcs.ca.gov のDrug Rebate Branchにお問い合わせください。​​ 

What is “EIS”?​​    

電子インターフェースシステム(EIS)を使用すると、購読している製薬会社は、現在の四半期の請求書を取得し、リベート請求書に基づいて10年分の請求情報をダウンロードできます。システムへのアクセスを取得する方法の詳細については、drugrebateportal@dhcs.ca.gov のDrug Rebate Branch Portalチームにお問い合わせください。​​  

EIS システムからの請求のオープン​​ 

支払い済み請求データのリンクを保存したら、7-Zip を使用してデータを Excel ファイルに変換できるテキスト形式に抽出します。​​   

ラベラーに終了したNDCがある場合の通知プロセスは何ですか?​​    

ラベラーは、NDCが終了した場合、Medi-Calフォーミュラリーファイルに最新の情報が含まれていることを確認するために、CMS および First Data Bank(FDB)に終了日を報告する必要があります。​​ 

CMS では、リベートの終了日を次のように定義しています。​​ 

  • 商品が薬局の棚から取り除かれた日付。又は​​ 
  • 最後に販売されたロットの有効期限(分配可能な最終日)​​ 

製薬会社は、終了日を過ぎた FOUR QUARTERS について、終了した医薬品の価格情報を報告する必要があります。​​ 

マネージドケア組織によって提出された請求はリベートの対象になりますか?​​   

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.​​ 

ROSIおよび/またはPQASは、ラベラーのリベート支払いとともに提出する必要がありますか?​​    

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.​​ 

ヘルスケアサービス部門
経理課
メディカル​​ 

医薬品リベート売掛金勘定
MS 1101の​​ 

私書箱997415​​ 

サクラメント、カリフォルニア州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.​​ 

     カリフォルニアのMedi-Calマネージドケアには何人の受益者が登録されていますか?​​  

登録データを含むマネージドケア情報については、 Medi-Cal Managed CareのWebページにアクセスしてください。​​ 

カリフォルニア州は、医薬品メーカーに複合請求に対するリベートの支払いを要求していますか?​​   

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 ​​