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PHARMACY PROVIDER MANUAL

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Page 1: PHARMACY PROVIDER MANUAL - mc-21.commc-21.com/.../2016/10/Manual_del_Proveedor_de_Farmacia_Ingles.pdf · 1 PHARMACY PROVIDER MANUAL MC-21’s Pharmacy Provider Manual is intended

PHARMACY PROVIDER MANUAL

Page 2: PHARMACY PROVIDER MANUAL - mc-21.commc-21.com/.../2016/10/Manual_del_Proveedor_de_Farmacia_Ingles.pdf · 1 PHARMACY PROVIDER MANUAL MC-21’s Pharmacy Provider Manual is intended

Table of Contents

Introduction ................................................................................................................................ 1Contact Information ................................................................................................................ 1Claims Processing ..................................................................................................................... 2 Eligibility .................................................................................................................................... 2 Online Adjudication .............................................................................................................. 2 Manual Claims ......................................................................................................................... 3Pharmacy Call Center .............................................................................................................. 3Prior-Authorizations ............................................................................................................... 3 Steps to an effective management of the prior-authorizations ............................ 3 “Dynamic PA” ............................................................................................................................ 4Clinical Edits ................................................................................................................................ 4 Step Therapy ............................................................................................................................ 4 Age Limits ................................................................................................................................. 5 Medical Specialty ................................................................................................................... 5 Quantity Limits ........................................................................................................................ 5Common Alert Messages....................................................................................................... 5Coordination of Benefits (COB) .......................................................................................... 7Quality Assurance Programs ............................................................................................... 8Pharmacy Services Department ......................................................................................11 Credentialing Process .........................................................................................................11 Re-credentialing Process ...................................................................................................12 Updates in Pharmacy Information .................................................................................12 Pharmacy Dispute Process ................................................................................................12 Pharmacy Reimbursement ...............................................................................................13 Record Keeping .....................................................................................................................13 Nondiscrimination ...............................................................................................................13 Good Pharmacy Practice ...................................................................................................13 Termination of services ......................................................................................................14 Privacy ......................................................................................................................................14 Pharmacy Audit ....................................................................................................................14Fraud, Waste and Abuse (FWA) ........................................................................................15 What is Fraud? .......................................................................................................................16 What is Abuse? ......................................................................................................................16 What is Waste? .......................................................................................................................16 How can Fraud, Waste, and Abuse be identified? ....................................................16 What happens when Fraud, Waste, and Abuse are identified? ..........................16 How can Fraud be prevented? ........................................................................................17 Fraud, Waste and Abuse Training ..................................................................................17Medicare Requirements ......................................................................................................18 Coverage Determination ...................................................................................................18 OIG .............................................................................................................................................18 Conflict of Interest ...............................................................................................................18 Vaccine Administration .....................................................................................................19 Electronic Prescription .......................................................................................................19

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PHARMACY PROVIDER MANUAL

MC-21’s Pharmacy Provider Manual is intended to serve you as a guide to assist your pharmacy

staff in claims processing, prior-authorizations, identify the quality of service expectations

that should be addressed, and other important related topics. Also, it will provide you a brief

summary of MC-21’s policies and procedures.

MC-21 was established in 1998 to develop and administer unique, tailored, and flexible

pharmacy programs for corporations, managed care organizations, unions, government

agencies, and others. We work very closely with our clients to achieve their goals by integrating

all pharmacy benefit components: clinical services, care management, technology, rebates,

and administrative support.

In 2009, MC-21 became the first Puerto Rican PBM to receive from URAC accreditation in

Pharmacy Benefit Management. URAC is an independent, nonprofit organization, leader in

promoting quality health care through its accreditation and

certification programs. This accreditation reaffirms MC-21’s

commitment with the quality and safety in health care.

We appreciate your participation in delivering pharmaceutical

care within our Pharmacy Network. We look forward to work

with you closely to provide high quality pharmacy services to our

client’s members. MC-21 will keep you informed with updated

information in order to promote the continued standard of care.

IntroductionWelcome to MC-21’s Pharmacy Network

Contact Information

Mailing Address Call Box 4908Caguas, PR 00726

Physical Address Angora Industrial ParkRoad 1, Km. 33.3, Lot #4Bo. BairoaCaguas, PR 00725

Administration T: 787-286-6032F: 787-653-2814(Monday to Friday from 8am – 5pm)

Pharmacy Call Center 1-888-311-60011-866-411-6001(Toll free, 24/7, 365 days a year)

Prior-Authorization Department T: 1-866-999-6221 / 1-866-989-6221 F: 1-866-277-6556 / 1-866-387-3487

E-mail [email protected]

Website www.mc-21.com

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Eligibility

Online Adjudication

Pharmacists are required to request the pharmacy benefit or the health plan card and an identification, to verify the cardholder identification number and date of birth for claim processing. The pharmacy benefit card or the health plan card must be the most current card issued to the customer. Customer eligibility can be verified through the online claims processing system or by calling the Pharmacy Call Center at 1-888-311-6001 or 1-866-411-6001.

MC-21’s claims adjudication system requires submitting claims electronically by pharmacy providers using the NCPDP D.O billing standard. MC-21’s electronic billing system is available to process claims in real time 24 hours a day, 365 days a year.

The following information will be required for online adjudication:

Input Code for Pharmacies MC21MC21 CORPORATION Bin Number ** 010868Processor Control Number ** Varies according to clients Group Number Varies according to clients Pharmacy ID Number (Qualifier 01) ** NPI #Member ID Field ** See member’s cardDate of Birth ** RequiredTelecommunication Standard NCPDP Version D.O

** Required fields

The pharmacy should verify with its’ software vendor the suitable system configuration needed for claim processing.

Claims Processing

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Pharmacy Call Center

Prior-Authorizations

Manual Claims

If, for any reason, the pharmacy cannot process electronically, it should submit to MC-21 the Universal Claim Form (UCF) with all related information about services rendered. This information and the electronic claim as well, should be submitted no later than 60 days after rendering services to the insured. This process requires prior-authorization by MC-21; therefore, the pharmacy must call our Pharmacy Call Center at 1-888-311-6001 or 1-866-411-6001. Our representatives will advice the pharmacy on how to obtain and how to fill out the UCF. This form is also available on our website: www.mc-21.com.

Our Pharmacy Call Center is staffed with fully bilingual pharmacists and pharmacy technicians that can effectively communicate with all users. MC-21’s Call Center is equipped with a state-of-the-art telecommunications system that provides all the necessary features to keep a help desk and customer service operations performing at optimum levels 7 days a week, 365 days a year. Our Customer Support Representatives will assist you with any questions regarding patients’ benefit plan, such as: eligibility, co-pay, deductible or co-insurance, clarification of alert messages, verification of physician participation in provider network and/or any other information you may need. The Pharmacy Call Center phone numbers are 1-888-311-6001 or 1-866-411-6001.

Documentación Requerida

Prior-Authorization is a tool employed by direct-based healthcare organizations, and requires the compliance of certain clinical-based standards before medication approval. The prior-authorization process assures the appropriate delivery of medications; meanwhile, expenses and mistakes are reduced and the adequate use of prescribed medications is encouraged.

Some prior-authorization standards include the patient’s diagnosis and recent lab tests. The patient’s diagnosis standard allows us to identify if the medication is being prescribed according to its FDA approved indication or clinical-treatment guidelines recommendations.

To ensure effective and timely evaluation of medications, the pharmacy must submit all required documentation and relevant to the case. Please see below for the general guidelines that should be followed, including the steps to resolve most common situations when a drug requires prior-authorization:

Steps to an effective management of the prior-authorizations

1. Check that the prescription meets all legal requirements (Ex.: date, quantity, directions, etc.).

2. Include all relevant information and documentation of the case, including the patient’s name, cardholder member ID, age, weight, etc. In some cases, additional information is required to perform the evaluation. See below some examples of additional documentation:

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3. Send documents by fax to our Prior-Authorization Center via 1-866-277-6556 or from 1-866-387-3487.

4. MC-21 will notify the pharmacy in writing of the determination of the case.

If the pharmacy does not submit the required documentation, MC-21 will submit a written notice specifying to the pharmacy there is a lack of information. The pharmacy will complete the missing information within a period of 24 hours. If the requested documentation is not received within the 24 hour period, MC-21 will send a written denial notice to the pharmacy stating that the case has been closed.

IMPORTANT:

To request a prior authorization, the pharmacy may complete and submit the Prior Authorization Request Form along with a copy of the prescription with any other information required. These documents should be faxed at 1-866-387-3487 or 1-866-277-6556. The pharmacy may call the Pharmacy Services Department to obtain the Prior Authorization Request Form.

“Dynamic PA”

Step Therapy

Dynamic Prior-Authorizations enables the Pharmacist to enter a special Prior-Authorization (PA) number that may create a PA automatically on the member record and allows the claim to pay. The pharmacy should process this claim using the provided prior-authorization code on the electronic claim. With this code, the system will allow the automatic adjudication. This process applies only to some plan designs and to some products. These claims, like any other regular claim, may be subject to an audit process.

Clinical Edits

ALERT MESSAGE

“PA Required” Patient’s Diagnosis

“Maximum Dose Exceded” Patient’s diagnosis and / or medical justification stating the reason for doses higher than the approved dosing

Step Therapy (Ex.: “Use Omeprazol first”)

Evidence of prior use of first-line drugs (Ex.: medication profile, letter from doctor, etc.)

Duplicate Therapy(Ex.: Enalapril y Ramipril)

Justification to support medical use of both drugs

DOCUMENTATION REQUIRED

The step therapy tool requires the use of a first-line medication, as established on the treatment guidelines, before approving a second-line medication. If the desired therapeutic benefit is not achieved with the first-line medication, then the second-line medication may be approved.

The previous use of the first-line medication may be identified automatically by the claims adjudication system. However, there are other methods to prove the required previous use of medications such as:

• Letterfromthephysiciancertifyingtheprevioususe• Thepatient’smedicationsprofileprovidedbythepharmacy• Thepatientdemonstratestheprevioususeunderanothercontractnumberorgroup

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PHARMACY PROVIDER MANUAL

Age Limits

Medical Specialty

Quantity Limits

The age limits edit ensure that a medication is used by the studied population in which the safety and effectiveness of such medication was proven. For example, a medication can be limited exclusively to a pediatric population or older than 18 years of age. This type of tool protects the non-studied population and guarantees the studied population access to the medication. This prevents morbidity and mortality related to these medications.

There are some medications which are required to be prescribed by certain specialists. Usually, these medications are specialty products and need a high experience level and monitoring from a physician specialized on certain health conditions. Examples are chemotherapy and biological therapies.

Quantity limits establish the drug units that will be approved for each prescription. This limit is based on the maximum effective dose approved by the FDA and evidenced by clinical studies. This tool prevents problems related to drugs, for example, the use of high doses which have the potential to harm the patient’s health. Also, the treatment can be limited for certain medications, according to clinical treatment guidelines. This strategy prevents inappropriate use of medications with unproven long-term benefits.

Pharmacy staff should call MC-21’s Pharmacy Call Center at 1-888-311-6001 or 1-866-411-6001 for assistance with any alert message. Some of the most frequent messages are:

1. Code 76—Plan Limitations Exceeded

If the cost is greater that $500, verify if the quantity of medication and its submitted costs are correct. If they are correct, please submit the Prior Authorization Request Form along with the prescription by fax to the Prior Authorization Center at 1-866-277-6556 or 1-866-387-3487. If you have any questions, please call the Pharmacy Call Center.

2. Code 76—Maximum Days Supply of 15

If the days supply or the quantity of medication charged are greater than those covered by the insured’s plan. Some plan designs have differences in days of supply for maintenance and/or acute medications, as defined on the coverage. Verify with the insured or call the Pharmacy Call Center.

Common Alert Messages

If you have information to support the prior use of a first-line drug, please submit the Prior Authorization Request Form along with the prescription and evidence of previous use by fax to the Prior Authorization Center at 1-866-277-6556 or 1-866-387-3487. If you have any questions, please call 1-866-999-6221 or 1-866-989-6221.

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3. Code 70—NDC Not Covered, Generic substitute required for Payment

Verify if the insured belongs to the private sector or to a government related program. If the insured is from the private sector, verify the patient’s coverage; it may indicate Generic Mandatory. You might be charging and original (Brand) medication and the rejection indicates that it must be substituted for a generic one to obtain payment (‘Generis Subst. Required for Payment’).

If the insured is from any government related program, verify if the medication is inside the formulary, and if it’s being prescribed by an authorized physician. If this is the case, it means that the medication charged has a generic substitute and the original (Brand) is not covered by the plan. If you have any questions, please call the Pharmacy Call Center.

4. Code 70—Plan Exclusion

Verify if the insured belongs to the private sector or to any government related program. If the insured is from the private sector, verify the patient’s coverage; the medication may be excluded or limited by medical specialty.

If the insured belongs to any government related program, verify if the medication is inside the formulary and if it’s being prescribed by an authorized physician. If you have any questions, please call the Pharmacy Call Center.

5. Code 88—DUR Reject Error

Verify if the quantity and the days supply are correct. If they are correct and the dosage is greater than the usual recommended dosage, you should call the physician for a dosage justification. Please submit the Prior Authorization Request Form along with the prescription and medical justification by fax at 1-866-277-6556 or 1-866-387-3487.

6. Code 77—Discontinued NDC Number

Our claims processing and adjudications system does not accept claims with inactive NDC numbers. A rejection for using an inactive NDC does not mean that the medication is not covered by the plan, but that it must be processed with an active NDC number. Verify with your supplier the available alternatives for active NDC numbers. If you have any questions, please call the Pharmacy Call Center.

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Coordination of Benefits (COB)

The Coordination of Benefits is a process that allows an insured to use two plans with pharmacy

benefits, a primary plan and a secondary plan, to obtain the same prescription. This information

can be obtained:

1. When processing the claim through the adjudication system, a message is received

indicating that the insured has an alternate plan.

2. The insured informs you that he/she has two plans with pharmacy benefit.

When processing a COB, the pharmacy must first process the claim to the insured’s primary plan.

The primary plan indicates how much it will pay for the claim. Then, the pharmacy processes

the claim to the secondary plan (BIN#, PCN and Group) using the same prescription number,

dispense date, NDC, quantity to-be-dispensed, days supply, and the refills submitted on the

primary claim. The allowed values on the “Other Coverage Code” field are:

1. 2=Other Coverage Exists – payment collected

2. 3=Other Coverage Exists – this claim not covered

The pharmacy should verify with its pharmacy software vendor the suitable system configuration

needed for coordination of benefits. For processing information or assistance, call the Pharmacy

Call Center.

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PHARMACY PROVIDER MANUAL

Quality Assurance Programs

MC-21 places a high value on medication safety practices and requires participating pharmacies to maintain quality assurance programs to improve and promote the quality and safety of its members. MC-21 expects that participating pharmacy providers provide a high quality of services that include the following:

• Assurance of prescription order authenticity• Ensure reasonable verification of the identity of the patient, prescriber and caregiver, when

applicable• Assure environmental standars that maintain the integrity of the medications while they are

stored and shipped• Assure appropiate accounting of controlled substances

Pharmacy providers should develop a quality assurance program and maintain ongoing processes to uncover potential risks while promoting ways to reduce vulnerability to error. Quality assurance programs should include internal medication error identification and reduction systems to assure the pharmacy is dispensing the correct drug, dosage, quantity, and directions to the correct eligible member.

Pharmacists are responsible for applying their professional judgment regarding the appropriate drug use. The quality assurance program should also include processes to verify the identity of the insured and the physician. MC-21 shall keep a registry of pharmacies that have been identified as potential security risk for the members. These pharmacies will be evaluated by the Quality Management Committee for the determination of corrective actions and / or other decisions as appropriate.

As part of the claims adjudication process, the MC-21 system has the ability to send alert messages when interactions are detected. You should familiarize yourself with your system to locate where you can view these messages. The messages are associated with the following levels of severity:

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Severity Level DescriptionMajor Interactions that are well documented and have the potential to

cause harm or that occur with a low incidence, but have the potential to cause serious adverse effects.

Moderate These interactions are associated to a lower probability of causing damage and are not as well documented.

Minor These interactions can occur but are less significant because the documentation is poor and conflicting. Are associated to a limited risk or no clear risk to the patient.

None There are no known interactions.

Depending on the severity level of interaction, the pharmacist can choose from several options to handle the finding. Always document the action taken.

• If the level of severity is major or moderate, please contact the physician to discuss alternatives such as changing medication, stop one of the drugs related to the interaction for a short period of time, adjusting the dose of one or both drugs, adjust the time in the day during which the drugs are administered, among others.

• If the severity level is minor, the pharmacist may choose to counsel the patient about the potential for interaction and advice him/her to communicate with the doctor if a problem arises.

Below are the most frequent drug-drug interactions with major severity level, detected by our claim adjudicating system during the fourth quarter of 2011 for Medicare patients:

Drug 1 Drug 2 Interaction Effect* Clinical Management*Simvastatin Amlodipine May result in increased

simvastatin exposure and increased risk of myopathy, including rhabdomyolysis

If it is necessary to coadminister amlodipine and simvastatin, the dose of simvastatin should not exceed 20 mg/day. Patients who are stabilized on an 80-mg dose of simvastatin for more than 1 year who need to start amlodipine should be switched to a statin or statin-based regimen with less potential for drug interaction.

Warfarin Simvastatin May result in increased risk of bleeding and an increased risk of rhabdomyolysis

Closely monitored the prothrombin time ratio or international normalized ratio (INR). Adjustments of the warfarin dose may be necessary in order to maintain the desired level of anticoagulation. Also monitor the patient for signs and symptoms of myopathy or rhabdomyolysis.

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Drug 1 Drug 2 Interaction Effect* Clinical Management*Clopidogrel Omeprazole Reduction in clinical efficacy

of clopidogrel and increased risk for thrombosis

Use alternative acid-reducing drug with less CYP2C19 inhibitory effect, such as pantoprazole, dexlansoprazole, or lansoprazole.

Diltiazem Simvastatin An increased serum concentrations of simvastatin and increased risk of myopathy, including rhabdomyolysis

If coadministration is necessary, dosages should not exceed 10 mg daily for simvastatin and 240 mg daily for diltiazem. Patients who are stabilized on an 80-mg dose of simvastatin for more than 1 year who need to start diltiazem should be switched to a statin-based regimen with less potential for drug interaction. Monitor for signs and symptoms of myopathy or rhabdomyolysis and creatine kinase (CK) levels if myopathy or rhabdomyolysis is diagnosed or suspected.

Fenofibrate Statins (Simvastatin, Crestor, Pravastatin)

An increased risk of myopathy or rhabdomyolysis

If concurrent therapy is deemed necessary, monitor the patient for signs and symptoms of myositis, myopathy or rhabdomyolysis and monitor serum creatine kinase levels. In the event of suspected or diagnosed myopathy/myositis, consider discontinuing one or both of the agents.

Levothyroxine Warfarin An increased risk of bleeding Adjustments of the anticoagulant dose may be necessary in order to maintain the desired level of anticoagulation.

Spironolactone Enalapril Hyperkalemia Although such increases are usually transient, monitor serum potassium levels for persistent elevations in patients on this combination, especially in patients with renal dysfunction or diabetes and the elderly. Severe arrhythmias and death have been reported from hyperkalemia with such combinations.

Tramadol/APAP SSRIs (Sertraline, Paroxetine)

An increased risk of seizures and serotonin syndrome (hypertension, hyperthermia, myoclonus, mental status changes)

If possible, avoid this combination, especially in patients with underlying conditions that might predispose to seizures. Observe the patient closely for signs and symptoms of serotonin syndrome.

*Micromedex Healthcare Series – June 27, 2012

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Pharmacy Services Department

Pharmacy provider’s communications, concerns, information requests, contracting documentation, and suggestions can be submitted to MC-21’s Pharmacy Services Department via fax to 787-653-2814, via e-mail to [email protected], or mailed to:

MC-21 CorporationPharmacy Services DepartmentPO BOX 4908Caguas, PR 00726

For general orientation on admission processes, changes in pharmacy information, network updates activities, or assistance with any pharmacy network issues call 787-286-6032, extensions 3111 or 3271.

Credentialing Process

All new petitioning pharmacies will be evaluated to confirm compliance with MC-21’s contracting requirements such as facility, inventory, and adequate structure necessary to provide a quality service. In addition, the pharmacy must submit all regulatory licenses and permits in accordance with state and federal law regulations, such as Pharmacy License from the Department of Health, Controlled Substances Licensing (ASSMCA, DEA) and Biological Products License.

In addition, the pharmacist must meet the following requirements: License from the Pharmacy Board of Puerto Rico and Certification of Continuing Education Registration.

Warfarin Amiodarone May result in serious or fatal bleeding

Decrease the warfarin dose by one-third to one-half and monitor the prothrombin time. In patients on chronic oral anticoagulant therapy with warfarin, a prophylactic 35 to 65% reduction in the warfarin dosage is recommended at the initiation of therapy with amiodarone. Intensive monitoring during the first 12 weeks is recommended.

Simvastatin Gemfibrozil An increased risk of myopathy or rhabdomyolysis

The concomitant use of gemfibrozil and simvastatin may increase the risk of developing myopathy/rhabdomyolysis and is contraindicated.

*Micromedex Healthcare Series – June 27, 2012

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Re-credentialing ProcessThe re-credentialing process validates if a participating pharmacy is still in compliance with the specified requirements contained on MC-21’s Services Agreement and those observed during the credentialing process.

As a participant provider of pharmacy services in MC-21’s network, the provider has the responsibility to observe the due dates of its licenses, permits and certifications, and send a copy of the updated documents. If the provider is undergoing renewal of any of these documents, relevant evidence of the renewal and the official document should be submitted once the renewal process is completed. These documents can be send to our Pharmacy Services Department by fax at 787-653-2814 or mail to:

MC-21 CorporationPharmacy Services DepartmentPO BOX 4908Caguas, PR 00726

If you have questions about the process of re-credentialing, call 787-286-6032, extension 3111 or 3271. If a pharmacy does not meet any of the required criteria, a reasonable time will be provided to submit a corrective action plan on the findings identified during the re-credentialing process.

Updates in Pharmacy InformationParticipating pharmacies should notify the NCPDP Agency any changes on demographic information. MC-21’s adjudication system receives NCPDP data files which contain updated information for new pharmacies and changes on existing pharmacies. Since this information is used for payment information or important notifications, pharmacies should verify and keep the information updated with NCPDP. Also, changes in pharmacy information such as phone number, fax, and address, among others, should be notified to MC-21. These changes are accepted only in written, filling the Request for Pharmacy Information Changes Form, which can be obtained calling our Pharmacy Services Department at 787-286-6032, extension 3111.

Pharmacy Dispute ProcessIf the participating pharmacy finds a discrepancy in payment reimbursement, prescriptions not paid, or have a dispute or concern regarding a claim or a pharmacy’s status within the pharmacy network, may submit the inquiry directly to MC-21’s Pharmacy Services Department. The Pharmacy should send the Pharmacy Dispute Form along with all the required evidence (according to the claim type) by fax to 787-653-2814. To obtain this form, please call our Pharmacy Services Department at 787-286-6032, extension 3111. MC-21 will evaluate the request and offer a response to the request.

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Pharmacy Reimbursement

Record Keeping

MC-21 processes payments to the pharmacies biweekly for the commercial sector and government sector. For the Medicare segment, payments are processed weekly. Each check is attached with the detail of each claim processed during that cycle. At the beginning of each year, a notification is sent to the pharmacies indicating the dates of payment for each cycle.

The Participating Pharmacy shall keep a document filing system regarding the services rendered to the Eligible Members. It shall retain the original prescriptions, the Signatures Registry of Eligible Members for a period of seven (7) years after the dispensing of the medication or per applicable law or MC-21’s business records. For Medicare Part D is 10 years as mandated by CMS (Centers for Medicare and Medicaid). Please, refer to MC-21 Pharmacy Services Agreement and applicable state and federal law for specific record retention requirements.

NondiscriminationThe participating pharmacy shall not discriminate against any insured member by reason of race, color, ethnicity, sex, marital status, sexual orientation, age or physical or mental disability.

It is the responsibility of the participating pharmacy to verify that its pharmacists comply with all professional credentials and with good pharmacy practices. MC-21 shall not be liable for claims arising from violations of such practices.

Good Pharmacy Practice

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The pharmacy shall keep all information contained in medical records of the insured members in strict confidence and disclose these records only if (a) it meets the Service Agreement, (b) is subject to applicable laws, regulations or orders of any court, particularly the approved HIPAA Privacy Rule if necessary, (c) another health care provider needs to treat the insured or (d) the insured consents by written notification.

Privacy

Our Pharmacy Audit Program includes both physical and desk audits. As part of this program, MC-21 verifies that participating pharmacies are in compliance with their contractual obligations and obtain information regarding errors, abuses and wrongful utilization of services.

Pharmacy Audit

The Service Agreement between MC-21 and the Participant Pharmacy shall continue in force for a term of two (2) years. After this term, the agreement will automatically renew for two (2) additional years, only if the participating pharmacy complies with the credentialing requirements established by the laws and regulations of the Commonwealth of Puerto Rico. If a pharmacy wishes to cancel its contract with MC-21 due to closure of operations or any other reason, a written notice must be submitted in accordance with the process set out in the Pharmacy Network Service Agreement. MC-21 may immediately exclude a network pharmacy from it’s networks if the pharmacy (a) licenses to dispense medications is suspended or revoked, (b) if the pharmacy is displayed in CMS exclusion lists, (c) if the pharmacy does not meet the criteria in the MC-21’s contract, (d) commits fraud, abuse and waste, or (e) any other illegal situation that could threaten the safety of the insured.

If the pharmacy does not agree with the determination of deactivation, the pharmacy shall have ten (10) days to appeal the decision. The pharmacy must submit a written notice containing sustainable information, explaining the reasons for which the deactivation should not be proceed. The pharmacy will receive a final determination within 5-7 business days. If additional time is needed, the pharmacy will be informed of the expected time for a final determination to be reached. Depending on the situation, you may be required to implement a corrective plan in order to consider the re-activation of the pharmacy into MC-21’s networks.

Termination of services

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MC-21 is committed to avoid, reduce and control the incidence of fraud, waste and abuse pursuant to federal and local laws. Effective January 1, 2009 first tier, downstream and related entities including pharmacies must complete appropriate FWA training that complies with CMS and MC-21’s requirements. This training should be completed by December 31st 2009, and annually thereafter.

In our efforts to prevent fraud, waste and abuse, we’ve developed the following guides to advice those pharmacies that provide services to beneficiaries from Medicare Part D. Our goal is to ensure that all pharmacy services providers for this program comply with all the medications processing and dispensing specifications, as established and according to CMS.

Fraud, Waste and Abuse (FWA)

For desktop audits, the auditor analyzes prescriptions from pharmacies to determine if claims were paid appropriately. For physical audits, pharmacies are selected based on the analysis of certain reports to detect trends in dispensing patterns. MC-21 selects the pharmacies using random sampling methods or based on certain statistical disparities.

Any pharmacy that shows suspicious behavior will be reported and may be subject to fines if irregularities are found, as permitted by our contractual agreement and the Pharmacy Law.

Participating Pharmacies shall keep up-to-date all the necessary information related submitted claims. MC 21 and/or its duly authorized agents will have access to those books, registries, records, files, manuals and electronic prescriptions of the Participating Pharmacy related to Eligible Members subject to all applicable state and federal laws and regulations governing the confidentiality of such records, in order to be able to do a complete audit.

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What is Fraud?

Fraud is defined as the intentional representation of an individual, who know it to be false, or does not believe it as true, and executes it knowing that such representation may result on an unauthorized benefit for him/her or any other person.

What is Abuse?

Abuse involves actions that are contradictory with acceptable fiscal practices for medicine or businesses. According to federal norms, “the abuse of Medicare is a minor fraud offence. It refers to incidents or practices that, directly or indirectly, cause loss to the Medicare Program, to its beneficiaries or families, and imply inconsistent practices with the accepted correct habits in the practice of medicine or businesses.”

What is Waste?

Waste occurs when a pharmacy or, in most cases, a beneficiary over-utilizes services

How can Fraud, Waste, and Abuse be identified?

All participating pharmacies are subject to be audited by any agency as established by CMS. This audit verifies if each prescription dispensed by the pharmacy complies with all the established requirements contained on the new Pharmacy Law (Law 247), MC-21’s Services Agreement requirements, and those appropriate regulatory agencies.

Pharmacies that are encountered with deficiencies will be re-instructed again and will be requested to submit a “corrective action plan” on such deficiencies. As required by CMS, MC-21 will establish with the pharmacy a “follow-up plan” to determine if the corrective actions implemented are functioning as expected.

If similar findings to those pointed out previously are identified, will treated it as a case of abuse and will be referred to MC-21’s Compliance Officer, who will evaluate and determine the action to be taken.

What happens when Fraud, Waste, and Abuse are identified?

When a pharmacy incurred in fraud, waste, and abuse, MC-21 Corporation will notify its Compliance Officer, the Health Insurance Company and/or Plan Sponsor. They will hold the resultant actions, according to CMS’ established requirements.

The PBM and the Plan Sponsor have the obligation to notify frauds to MEDICS, a contracted company by CMS for fraud management, who will determine which course to take.

Remember, fraud is a crime punished by the law.

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How can Fraud be prevented?

Each pharmacy is responsible for documenting and guaranteeing that all charged claims comply with CMS’s established requirements, and those from the regulatory agencies, for dispense of medications. They are also responsible for implementing and complying with all the necessary controls to prevent any situation that might be considered abusive or fraudulent.

In our additional effort to fight fraud, Pharmacy Services Providers can notify cases in which they understand fraud is involved by calling at 787-286-6032, extension 3800. Every provider must have the necessary information to report a case. Each case reported will be treated with the strictest confidentiality. Calls with incomplete information will not be considered for investigation. See below the minimum information required to report a suspicious fraud case:

1. Name of the Pharmacy/Person 2. Phone number of the person calling 3. A brief explanation of the situation to-be-reported

People who contact our line to report possible fraud, waste, and/or abuse are not required to reveal their identity. However, depending on the reported situation and the twist the investigation may take, it might be necessary to identify the person who reported the possible fraud, waste, and/or abuse. Reports with limited information and lack of specific necessary details to complete the investigation will be archived until such information may be reported or provided.

Each case reported will be treated individually with strict confidentiality and in compliance with all privacy parameter established by CMS. The identity of the person providing the information will not be revealed without his/her consent, unless MEDICS or any other regulatory agency determines that is absolutely necessary to disseminate his/her identity during the course of the investigation.

Fraud, Waste and Abuse Training

The pharmacy is responsible to provide the necessary trainings regarding Fraud, Waste and Abuse prevention to its employees at the date of hire, including managers and directors. This training must be repeated annually. In addition, the pharmacy must keep copy of the training and evidence that the training was offered, in case is requested by MC-21.

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Medicare Requirements

Coverage Determination

OIG

As established by CMS, under the regulation published on April 15, 2011 (CMS-4144-F), the participating pharmacies have to advise, in written form, the beneficiaries regarding their Rights to contact their Medicare plan and obtain a coverage determination. This advice given to the beneficiary has to be performed through the hand delivery of a standard notification approved by CMS, which explains the beneficiaries’ rights to request a coverage determination. The advise must be performed every time the pharmacy receives an Electronic message indicating that the claim is not covered.

Every participating pharmacy must check all CMS Exclusions Lists such as Office of Inspector General (OIG / http://www.oig.hhs.gov/) and Exclude Parties List System (EPLS /http://www.epls.gov ).

The pharmacy must check these lists every time it hires new personnel and then annually, to ensure that none of its employees are excluded on either lists to work with federal programs. These revisions must be documented and archived by the pharmacy for evidence.

If an employee is indeed listed in either exclusions lists, he/she shall be removed immediately from any direct or indirect activity related to Medicare, and the pharmacy must take the necessary corrective actions.

Conflict of interest

The participating pharmacy must assure that its employees, responsible for the administration or dispensing of medications under Medicare Part D, do not have any conflict of interest whatsoever for administering or dispensing medications for Medicare Part D.

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Vaccine AdministrationSince January 1st, 2008, the cost for administering certain vaccines is being covered by the Medicare Part D program. As a result, the beneficiary has a variety of options to receive services associated with the purchase and the administration of vaccines:

1. Pharmacy dispatches and administers the vaccineThe beneficiary has the option to go to a pharmacy to buy a vaccine and be administered in the same pharmacy. • Thispharmacyshouldhaveanauthorizedhealthcareprofessionaltoadministersuch vaccine, according to the laws of Puerto Rico. • Thepharmacymustprocesselectronically,throughasingletransaction,the cost associated with the vaccine sold and its administration (to get the processing requirements, please call our Pharmacy Services Department).

2. Pharmacy only dispatches the vaccine• The pharmacy does not have an authorized professional to administer vaccines or

the beneficiary prefers to buy the vaccine only and then be administered by another healthcare provider.• In this case, the pharmacy will only charge the cost of the vaccine.• The beneficiary must pay the cost associated with the administration of such vaccine

to the selected healthcare provider and later he/she must submit a reimbursement request to the Medical Plan.

To participate on our Vaccine Administration Network (option 1), the pharmacy must send all required credentials of the healthcare professional who will administer vaccines, and the Compensation Attachment (MC-21 Compensation Attachment/Medicare Part D/Vaccine Administration) already signed. Option 2 does not require any action from the pharmacy at all. If you need additional information, call the Pharmacy Services Department at 787-286-6032, extension 3111.

Electronic PrescriptionThe Pharmacy Law of Puerto Rico (Act No. 247 of September 3, 2004), was amended with Act No. 138 on November 16, 2009 to allow the release of electronic prescriptions without a handwritten signed prescription. Electronic prescribing is defined as electronic generation and transmittal of a prescription from the prescriber to a pharmacy freely selected by the patient, through a system that authenticates the electronic signature of the prescriber and ensure the security of the transmission in accordance with the applicable standards, laws and regulations. For purposes of this Act, a prescription that is generated and transmitted electronically is also known as electronic prescription, and constitutes an original order, so an order with handwritten signature will not be required. This Act came in effect 30 days after the adoption of Regulation No. 142 of August 9, 2010, which incorporated the new provisions to the Pharmacy Regulation.

The pharmacy must comply with electronic prescribing standards, security and transmission of electronic prescriptions as defined by CMS, when receiving or transmitting electronic prescriptions or prescription-related information.

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All rights reserved. The Pharmacy Provider Manual and other documents provided to the pharmacy owned by MC-21, are confidential and remain the property of MC-21. The information contained in those documents can not

be released to third parties without the written consent of MC-21.

Revised in September 2015.

Angora Industrial ParkHighway 1 Km 33.3 Lot # 4

Bo. Bairoa Caguas, Puerto Rico 00725

787-286-6032

www.mc-21.com