Tahanan Mga Tagapagbigay ng Serbisyo at Kasosyo Mga Madalas Itanong tungkol sa mga Rebate ng Gamot ng Medi-Cal​​ 

Mga Madalas Itanong tungkol sa Mga Rebate sa Gamot ng Medi-Cal​​ 

Pangkalahatang Tanong​​ 

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.​​ 

Ang mga karagdagang rebate ba ay napapailalim sa mga singil sa interes?​​      

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:​​ 

  • Kung ang isang karagdagang bayad ay hindi natanggap sa loob ng 38 araw mula sa petsa ng postmark ng invoice, ang interes na kinakalkula sa CMS rate (Lingguhang Federal Treasury-bill rate) ay dapat bayaran.​​ 
  • Kung ang isang karagdagang bayad ay hindi natanggap sa loob ng 69 na araw mula sa petsa ng postmark ng invoice, isang multa sa interes na 10 porsyentong puntos ay idaragdag sa rate ng interes ng CMS. Ang interes at 10% na parusa ay patuloy na naipon hanggang sa postmark na petsa ng pagbabayad.​​ 

Makakakuha ba ako ng hiwalay na invoice para sa mga karagdagang rebate?​​    

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.​​ 

Ano ang Mga Batas ng Pederal at Estado hinggil sa Programa ng Rebate ng Gamot sa California/Pederal na Batas?​​     

Pederal na Batas:​​ 

Social Security Act Section 1927 [42 USC 1396r-8] (a)​​  

Pederal na batas na may kaugnayan sa Medicaid (Medi-Cal sa California) Drug Rebate Programa. Bisitahin ang webpage ng Social Security para sa higit pang impormasyon.​​ 

Batas ng Estado:​​ 

  • 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.​​ 

Anong mga uri ng Programa ang nasasangkot sa Programa ng Rebate sa Gamot ng Department of Health Care Services?​​ 

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”?​​   

Ang Healthcare Common Procedure Coding System (HCPCS) ay isang pambansa, pare-parehong istruktura ng coding na binuo ng Centers for Medicare & Medicaid Services (CMS) upang i-standardize ang mga coding system na ginagamit upang iproseso ang mga claim ng Medicare at Medicaid (Medi-Cal) sa isang pambansang batayan.​​ 

Ang mga paghahabol sa Gamot na Pinangangasiwaan ng Doktor ay nangangailangan ng isang HCPCS code upang matukoy ang pamamaraan at upang matukoy ang halaga na ibabalik sa provider. Higit pa rito, ang lahat ng claim sa Physician Administered Drugs (PAD) ay dapat na kasama ang National Drug Code (NDC) upang ang tagagawa ng gamot ay ma-invoice para sa mga rebate. Ang DHCS ay nangangailangan din ng mga claim na puno ng 340B na binili na gamot na isama ang "UD" modifier, na nag-aalis ng claim mula sa invoice ng rebate ng gamot ng gumawa ng gamot.​​ 

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.​​ 

Ilang COHS ang mayroon?​​    

Mayroong anim na plano ng COHS na sumasaklaw sa 22 county.​​ 

  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.​​ 

Ang waiver ng programa ng Medicaid upang mangolekta ng mga rebate ng gamot para sa paggamit ng CCS at GHPP na pang-estado ay nag-expire noong Disyembre 31, 2020. Dahil sa hindi pagpapalawig ng pederal na pagpopondo para sa mga populasyon ng CCS at GHPP, wala nang awtoridad ang DHCS na mag-invoice at mangolekta ng mga rebate sa gamot ng pederal na Medicaid para sa mga programang ito. Noong Q1 2021, ang mga invoice ng CCS at GHPP ay inalis sa pag-invoice.​​ 

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.​​ 

Ano ang 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.​​  

Ano ang rate ng reimbursement ng California para sa mga claim sa parmasya?​​    

Epektibo para sa mga claim sa parmasya na may mga petsa ng serbisyo sa o pagkatapos ng Abril 1, 2017, ang Medi-Cal ay nagre-reimburse batay sa mas mababang Actual Acquisition Cost (AAC) kasama ang isang propesyonal na dispensing fee, o karaniwan at nakasanayang mga singil. Ang AAC ay tinutukoy bilang pinakamababa sa:​​ 

  • National Average Drug Acquisition Cost (NADAC), o Wholesale Acquisition Cost (WAC) + 0% kung hindi available ang NADAC,​​ 
  • Federal Upper Limit (FUL), o​​ 
  • Maximum Allowable Ingredient Cost (MAIC).​​ 

Ano ang maximum na bilang ng mga araw na supply ng California kapag nagbibigay ng mga gamot?​​    

Ang California ay may 100-araw na maximum na supply para sa karamihan ng mga gamot. Naiiba ito sa maraming iba pang mga estado na mayroong maximum na 30-araw na supply. Mahalagang isaalang-alang ang 100-araw na maximum na supply kapag pinagtatalunan ang paggamit.​​ 

Bakit binabayaran ng Medi-Cal ang ilang provider sa mababang halaga?​​      

Ang binabayarang dolyar ay hindi palaging ang pinakamahusay na tagapagpahiwatig kung gaano karaming mga yunit (tablet, milligrams, vial, atbp.) ng gamot ang naibigay dahil hindi kasama sa ilang provider ang lahat ng impormasyon.​​ 

Ang ibang impormasyon sa Health Coverage o Third Party Liability (TPL) ay minsan ay hindi kasama sa claim ng Medi-Cal. It is normal to see providers reimbursed only for the co-pay (i.e. $5, $15, $30, atbp.) nang walang anumang data ng TPL. Para sa kadahilanang iyon, tama ang karamihan sa mga claim na may mababang halaga ng reimbursement at tama rin ang mga unit na na-invoice para sa mga rebate.​​ 

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.​​ 

Maaari bang mag-iba at/o ma-override ang mga normal na kasanayan sa reseta?​​   

Oo. Maaaring gamitin ang Treatment Authorization Request (TAR) upang i-override ang mga normal na kasanayan sa reseta (hal mga reseta na lampas sa anim na reseta sa isang pagkakataon para sa isang benepisyaryo, mga dami na mas malaki kaysa sa karaniwang mga dami ng dispensing, mga gamot na wala sa Listahan ng mga Contract na Gamot, atbp.)​​ 

Bakit kailangan kong magsumite ng data ng Average Manufacturers Price (AMP) para sa ilang partikular na NDC?​​    

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.​​ 

Kailan dapat itakda ang data ng Average Manufacturer Pricing (AMP) sa California?​​     

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?​​   

Dapat malaman ng mga label na kung hindi nila isusumite ang kanilang data sa loob ng dalawang magkasunod na quarter, maaaring wakasan o hindi na i-renew ang kanilang kontrata sa California Supplemental AMP kapag nag-expire ang kasalukuyang kontrata. Kung walang aktibong kontrata, maaaring gawing available lamang ng DHCS ang gamot ng may label sa pamamagitan ng paunang awtorisasyon.​​ 

Paano ako magsusumite ng data ng AMP?​​ 

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.​​  

Paano kung magbago ang aking AMP?​​    

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.​​  

Paano ko malalaman kung maling naisumite ang aking AMP data (hal format, nawawalang data, atbp.)?​​ 

Makikipag-ugnayan si Gainwell o ang analyst ng rebate ng gamot sa labeler kung may mga problema sa isinumiteng data ng AMP.​​ 

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

Makipag-ugnayan sa iyong DHCS drug rebate analyst o makipag-ugnayan sa iyong kinatawan ng gobyerno sa Pharmacy Drug Contracting Branch.​​ 

Ano ang kuwalipikado sa isang Provider bilang isang entity ng Public Health Services (PHS) sa California at karapat-dapat para sa 340B na pagpepresyo?​​     

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.​​  

Kailangan bang tukuyin ng provider ang mga claim kung saan tumatanggap ang mga benepisyaryo ng Medi-Cal ng 340B na binili na gamot?​​    

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”?​​   

Ang opsyon sa pagbabayad ng Electronic Fund Transfer (EFT) ay nagpapahintulot sa mga nakarehistrong user na bayaran ang kanilang mga invoice ng rebate ng gamot sa elektronikong paraan nang hindi kinakailangang magsumite ng mga tradisyunal na tseke sa papel. Ang boluntaryong opsyon na ito ay nangangailangan ng mga kalahok na sumunod sa isang partikular na format kapag nagsusumite ng electronic data.  Mangyaring makipag-ugnayan sa Sangay ng Rebate ng Gamot sa drugrebatebranch@dhcs.ca.gov, para sa karagdagang impormasyon kung paano mag-sign up para sa EFT.​​ 

What is “EIS”?​​    

Ang Electronic Interface System (EIS) ay nagbibigay-daan sa pag-subscribe sa mga tagagawa ng gamot na kunin ang kasalukuyang quarter invoice at mag-download ng 10 taon ng impormasyon sa paghahabol batay sa mga invoice ng rebate.   Mangyaring makipag-ugnayan sa koponan ng Portal ng Sangay ng Rebate ng Gamot sa drugrebateportal@dhcs.ca.gov, para sa karagdagang impormasyon kung paano makakuha ng access sa system.​​  

Pagbubukas ng Mga Claim mula sa EIS System​​ 

Pagkatapos i-save ang link ng data ng bayad na claim, gamitin ang 7-Zip upang i-extract ang data sa isang text format na maaaring ma-convert sa isang Excel file.​​   

Ano ang proseso ng pag-abiso kung ang isang tagapag-label ay may NDC na winakasan?​​    

Ang mga label ay dapat mag-ulat ng petsa ng pagwawakas sa CMS AT First Data Bank (FDB) kung sakaling ang isang NDC ay winakasan upang matiyak na ang Medi-Cal formulary file ay may pinakabagong impormasyon.​​ 

Tinutukoy ng CMS ang petsa ng pagwawakas para sa mga rebate bilang:​​ 

  • Petsa ng pagtanggal ng produkto sa mga istante ng parmasya; o​​ 
  • Petsa ng shelf life (huling petsa kung kailan ito maaring ibigay) ng huling lote na naibenta​​ 

Kinakailangan ng mga tagagawa ng gamot na mag-ulat ng impormasyon sa pagpepresyo para sa mga winakasan na gamot para sa APAT NA KWARTA lampas sa petsa ng pagwawakas.​​ 

Ang mga Claim ba ay isinumite ng mga organisasyon ng pinamamahalaang pangangalaga ay napapailalim sa mga rebate?​​   

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.​​ 

Kinakailangan ba na isumite ang ROSI at/o PQAS na may kasamang pagbabayad ng rebate ng labeler?​​    

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.​​ 

Department of Health Care Services
Accounting Section
Medi-Cal​​ 

Mga Receivable na Account sa Rebate sa Droga
MS 1101​​ 

PO Box 997415​​ 

Sacramento, CA 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.​​ 

     Ilang benepisyaryo ang naka-enroll sa Medi-Cal Managed Care sa California?​​  

Para sa impormasyon ng pinamamahalaang pangangalaga, kabilang ang data ng pagpapatala, bisitahin ang webpage ng Medi-Cal Managed Care.​​ 

Inaatasan ba ng California ang mga tagagawa ng gamot na magbayad ng mga rebate sa mga compound claim?​​   

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.​​  

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