홈 제공자 & 파트너 Medi-Cal 의약품 리베이트에 대해 자주 묻는 질문​​ 

Medi-Cal 의약품 리베이트에 대해 자주 묻는 질문​​ 

일반적인 질문​​ 

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.​​ 

추가 리베이트에는 이자가 부과되나요?​​      

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:​​ 

  • 인보이스 소인일로부터 38일 이내에 추가 결제를 받지 못하면 CMS 이율(주간 연방 재무부 채권 이율)로 계산한 이자를 지불해야 합니다.​​ 
  • 인보이스 소인일로부터 69일 이내에 추가 결제를 받지 못하면 CMS 이자율에 10%포인트의 이자 패널티가 추가됩니다. 이자와 10%의 벌금은 결제 소인이 찍힌 날까지 계속 발생합니다.​​ 

추가 리베이트에 대한 별도의 청구서를 받나요?​​    

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.​​ 

캘리포니아/연방법의 의약품 리베이트 프로그램에 관한 연방법 및 주법은 무엇인가요?​​     

연방법:​​ 

사회보장법 섹션 1927 [42 U.S.C. 1396r-8] (a)​​  

메디케이드(캘리포니아의 경우Medi-Cal ) 의약품 리베이트 프로그램과 관련된 연방법. 자세한 내용은 사회보장 웹페이지를 참조하세요.​​ 

주법:​​ 

  • 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.​​ 

보건복지부 의약품 리베이트 프로그램에는 어떤 유형의 프로그램이 포함되나요?​​ 

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(의료 공통 절차 코딩 시스템)는 Medicare 및 메디케이드 서비스 센터(CMS)에서 전국적으로 Medicare 및 메디케이드(Medi-Cal) 청구를 처리하는 데 사용되는 코딩 시스템을 표준화하기 위해 개발한 전국 단위의 통일된 코딩 구조입니다.​​ 

의사 투여 의약품 청구에는 절차를 식별하고 제공자에게 환급할 금액을 결정하기 위해 HCPCS 코드가 필요합니다. 또한 모든 의사 투여 의약품(PAD) 청구에는 국가 의약품 코드(NDC)가 포함되어야 의약품 제조업체에 리베이트가 청구될 수 있습니다. 또한 DHCS는 340B 구매 의약품으로 작성된 청구에 제약 제조업체의 의약품 리베이트 청구서에서 청구를 제거하는 "UD" 수정자를 포함하도록 요구합니다.​​ 

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.​​ 

COHS는 몇 개나 있나요?​​    

22개 카운티를 대상으로 하는 6개의 COHS 플랜이 있습니다.​​ 

  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.​​ 

주 전용 CCS 및 GHPP 이용에 대한 의약품 리베이트 징수에 대한 메디케이드 프로그램 면제는 12월 1일에 만료되었습니다 31, 2020. CCS 및 GHPP 인구에 대한 연방 자금 지원이 연장되지 않았기 때문에 DHCS는 더 이상 이러한 프로그램에 대한 연방 메디케이드 의약품 리베이트를 청구하고 징수할 권한이 없습니다. 2021년 1분기부터 CCS 및 GHPP 인보이스는 인보이스 발행에서 제외되었습니다.​​ 

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.​​ 

BCCTP란 무엇인가요?​​    

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.​​  

캘리포니아의 약국 청구에 대한 환급률은 얼마인가요?​​    

2017년 4월 1일 이후 서비스 날짜가 있는 약국 청구에 대해 Medi-Cal은 실제 취득 비용(AAC)에 전문 조제료를 더한 금액 또는 일반적이고 관례적인 비용 중 낮은 금액을 기준으로 환급합니다. AAC는 다음 중 가장 낮은 것으로 결정됩니다:​​ 

  • 국가 평균 의약품 구입 비용(NADAC) 또는 NADAC를 사용할 수 없는 경우 도매 구입 비용(WAC) + 0%,​​ 
  • 연방 상한선(FUL) 또는​​ 
  • 최대 허용 성분 비용(MAIC).​​ 

의약품 조제 시 캘리포니아의 최대 공급 일수는 어떻게 되나요?​​    

캘리포니아에서는 대부분의 약품에 대해 최대 100일 동안 공급이 가능합니다. 이는 최대 30일 공급량을 제공하는 다른 많은 주와 다릅니다. 사용량에 대해 이의를 제기할 때는 100일 최대 공급량을 고려하는 것이 중요합니다.​​ 

Medi-Cal이 일부 제공자에게 낮은 비율로 환급하는 이유는 무엇입니까?​​      

일부 제공업체는 모든 정보를 포함하지 않기 때문에 환급된 금액이 항상 얼마나 많은 단위(정제, 밀리그램, 바이알 등)의 약품이 조제되었는지를 나타내는 최선의 지표는 아닙니다.​​ 

기타 건강 보험 또는 제3자 책임(TPL) 정보는 때때로 Medi-Cal 청구에 포함되지 않는 경우가 있습니다. 일반적으로 공급자는 본인 부담금에 대해서만 환급을 받는 것이 일반적입니다(예 5, $15, $30 등)를 TPL 데이터 없이 사용할 수 있습니다. 따라서 환급 금액이 낮은 대부분의 청구는 정확하며 리베이트 청구 단위도 정확합니다.​​ 

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.​​ 

일반적인 처방 관행이 변경되거나 재정의될 수 있나요?​​   

예. TAR(치료 승인 요청)을 사용하여 일반적인 처방 관행을 무시할 수 있습니다(즉, 다음과 같이). 한 명의 수혜자에 대해 한 번에 6건을 초과하는 처방전, 일반적인 조제 수량보다 많은 수량, 계약 의약품 목록에 없는 의약품 등).​​ 

특정 NDC에 대해 평균 제조사 가격(AMP) 데이터를 제출해야 하는 이유는 무엇인가요?​​    

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.​​ 

캘리포니아에서 평균 제조업체 가격(AMP) 데이터의 기한은 언제인가요?​​     

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?​​   

라벨 제작자는 2분기 연속으로 데이터를 제출하지 않으면 캘리포니아 보충 AMP 계약이 해지되거나 현재 계약이 만료될 때 갱신되지 않을 수 있다는 점에 유의해야 합니다. 활성 계약이 없으면 DHCS는 사전 승인을 통해서만 라벨러의 의약품을 제공할 수 있습니다.​​ 

AMP 데이터는 어떻게 제출하나요?​​ 

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.​​  

AMP가 변경되면 어떻게 되나요?​​    

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 데이터가 잘못 제출되었는지 어떻게 알 수 있나요? 형식, 누락된 데이터 등)?​​ 

제출된 AMP 데이터에 문제가 있는 경우 Gainwell 또는 의약품 리베이트 분석가가 라벨러에게 연락합니다.​​ 

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

DHCS 의약품 리베이트 분석가에게 문의하거나 정부 담당자가 약국 의약품 계약 지점에 연락하도록 하세요.​​ 

의료 서비스 제공자가 캘리포니아에서 공중 보건 서비스(PHS) 기관으로서 340B 가격을 받을 수 있는 자격을 갖추려면 어떻게 해야 하나요?​​     

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.​​  

의료 서비스 제공자는 Medi-Cal 수혜자가 340B 구매 의약품을 수령한 청구를 식별해야 합니까?​​    

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”?​​   

전자 자금 이체(EFT) 결제 옵션을 사용하면 등록된 사용자가 기존의 종이 수표를 제출하지 않고도 의약품 리베이트 청구서를 전자적으로 결제할 수 있습니다. 이 자발적 옵션은 참가자가 전자 데이터를 제출할 때 특정 형식을 준수하도록 요구합니다.  EFT 가입 방법에 대한 자세한 내용은 의약품 리베이트 지점(drugrebatebranch@dhcs.ca.gov)에 문의하세요.​​ 

What is “EIS”?​​    

EIS(전자 인터페이스 시스템)를 통해 가입한 제약 제조업체는 현재 분기 청구서를 검색하고 리베이트 청구서를 기반으로 10년간의 청구 정보를 다운로드할 수 있습니다.   시스템에 액세스하는 방법에 대한 자세한 내용은 의약품 리베이트 지점 포털 팀(drugrebateportal@dhcs.ca.gov)에 문의하세요.​​  

EIS 시스템에서 클레임 개설​​ 

유료 청구 데이터 링크를 저장한 후 7-Zip을 사용하여 데이터를 Excel 파일로 변환할 수 있는 텍스트 형식으로 추출합니다.​​   

라벨러가 해지된 NDC가 있는 경우 알림 절차는 어떻게 되나요?​​    

라벨 제작자는 NDC가 종료되는 경우 CMS 및 퍼스트 데이터 뱅크(FDB)에 종료 날짜를 보고하여 Medi-Cal 처방전 파일에 최신 정보가 있는지 확인해야 합니다.​​ 

CMS는 리베이트 종료일을 다음과 같이 정의합니다:​​ 

  • 약국 진열대에서 제품이 제거된 날짜 또는​​ 
  • 마지막으로 판매된 로트의 유통 기한 날짜(조제 가능한 마지막 날짜)​​ 

의약품 제조업체는 종료된 의약품의 가격 정보를 종료일 이후 4/4분기 동안 보고해야 합니다.​​ 

관리 의료 기관에서 제출한 청구에는 리베이트가 적용되나요?​​   

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.​​ 

라벨러의 리베이트 지급 시 ROSI 및/또는 PQAS를 제출해야 하나요?​​    

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.​​ 

의료 서비스 부서
회계 섹션
Medi-Cal​​ 

의약품 리베이트 미수금
MS 1101​​ 

우편함 997415​​ 

새크라멘토, 캘리포니아 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.​​ 

     캘리포니아에서 Medi-Cal Managed Care 에 등록된 수혜자는 몇 명인가요?​​  

등록 데이터를 포함한 매니지드 케어 정보는 Medi-Cal Managed Care 웹페이지를 참조하세요.​​ 

캘리포니아에서는 제약 제조업체가 복합 청구에 대해 리베이트를 지급해야 하나요?​​   

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 ​​