version 11.7.2016 10:00 a.m. pharmacy network providers manual · version 11.7.2016 10:00 a.m....

Version 11.7.2016 10:00 a.m.

Pharmacy Network

Providers Manual

People caring for people…

Pharmacy Network Providers Manual


Table of Contents Pharmacy Network Call Center .......................................................................................................... 6

Prior Authorization Call Center .......................................................................................................... 6

Claims Processing ...................................................................................................................................................7

Protecting Privileged Health Information .........................................................................................................7

Eligibility .............................................................................................................................................................7

On Line Adjudication System.............................................................................................................................7

Manual Claims ....................................................................................................................................................8

Clinical DUR Edits ...................................................................................................................................................8

Prior Authorizations (PA) ...................................................................................................................................8

Steps to an Effective Management of a Prior Authorization ...........................................................................8

Incomplete Prior Authorization Requests .........................................................................................................8

Confirmation of a Successful Fax Transmission ................................................................................................9

Dynamic Prior Authorization (DPA)................................................................................................................ 10

Step Therapy (ST) ............................................................................................................................................ 10

Age Limit (AL) .................................................................................................................................................. 10

Medical Specialty Restriction ......................................................................................................................... 11

Quantity Limits (QL) ........................................................................................................................................ 11

Coordination of Benefits .................................................................................................................................... 11

Drug Interactions ................................................................................................................................................ 11

Compounds ......................................................................................................................................................... 12

Flex – 90™ Program............................................................................................................................................. 13

Common Alert Messages .................................................................................................................................... 13

Pharmacy Dispute Process ................................................................................................................................. 15

Maximum Allowable Cost (MAC) Appeal Process ............................................................................................. 15

Quality Assurance Programs .............................................................................................................................. 16

Communications to Pharmacy Network Members ........................................................................................... 16

Pharmacy Services Center ............................................................................................................... 17

Credentialing Process ......................................................................................................................................... 17

Contracts Terms .................................................................................................................................................. 18

Re-Credentialing ................................................................................................................................................. 18

Termination of Services ...................................................................................................................................... 18


Updates in Pharmacy Information ..................................................................................................................... 19

Pharmacy Reimbursements................................................................................................................................ 19

Record Keeping ................................................................................................................................................... 19

Non-Discrimination Policy .................................................................................................................................. 19

Good Pharmacy Practice ..................................................................................................................................... 19

Protected Health Information ............................................................................................................................ 20

Pharmacy Audits ................................................................................................................................................. 20

Fraud, Waste and Abuse (FWA) ......................................................................................................................... 21

What is Fraud? ................................................................................................................................................ 21

What is Abuse? ............................................................................................................................................... 21

What is Waste? ............................................................................................................................................... 21

How can Fraud, Waste and Abuse be Identified? .......................................................................................... 21

What happens when Fraud, Waste, and Abuse are identified? ................................................................... 21

How can Fraud be Prevented? ....................................................................................................................... 22

Medicare Part D Compliance Requirements ...................................................................................................... 23

Coverage Determination ................................................................................................................................ 23

CMS Exclusion Lists ......................................................................................................................................... 23

Conflict of Interest .......................................................................................................................................... 23

Code of Conduct and Ethics ............................................................................................................................ 23

Medicare Part D MAC Pricing ......................................................................................................................... 23

Vaccine Administration .................................................................................................................................. 24

Electronic Prescriptions .................................................................................................................................. 24

MC-21 on the Internet ..................................................................................................................... 26

Circular Letters and Updates .............................................................................................................................. 26

FWA Training and Attestation Forms ................................................................................................................. 26

Medicare Part D MAC Pricing ............................................................................................................................. 26

MC-21 Code of Ethics and Conduct .................................................................................................................... 26

Pharmacy Dispute Form ..................................................................................................................................... 26

Pharmacy Guide for MAC Price Review ............................................................................................................. 26

Pharmacy Information Update ........................................................................................................................... 26

Prior Authorization Request Form ..................................................................................................................... 26

Universal Claim Form (UFC) ................................................................................................................................ 26


Welcome to MC-21’s Pharmacy Network

Welcome to MC-21’s Pharmacy Network. Your partnership in delivering pharmaceutical

care within our Pharmacy Network is highly valued.

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 other entities. We take great pride in collaborating with our clients to

achieve their business goals by integrating all pharmacy benefit components: pharmacy

networks, formulary management, pharmacy communications, drug utilization review,

clinical services, care management, technology, rebates administration, claims processing

and administrative support.

In 2009, MC-21 became the first Puerto Rican Pharmacy Benefit Manager (PBM) to attain

the URAC Pharmacy Benefit Management Accreditation, and since then has consistently

complied with URAC standards, thus revalidating its accreditation. 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 upmost quality and safety

standards in health care services.

This Pharmacy Providers Manual provides a summary of MC-

21’s policies and procedures and establishes the quality of

service standards expected from our pharmacy network

members. It is also intended to serve your pharmacy staff as a

working tool to guide your staff through the day-to-day transactions, such as claims

processing and prior-authorizations management, and provides important information to

better understand the processes related.

MC-21 will keep you posted with relevant and updated instructions, notices, information,

supplements and subsequent revisions of this manual, in order to promote continued

standard of care quality.

We look forward to working together in providing high quality pharmacy services to our

client’s members.


6

Pharmacy Network Call Center

Our Pharmacy Network Call Center is staffed with knowledgeable, fully bilingual pharmacists and

pharmacy technicians to effectively assist you during your call. MC-21’s Pharmacy Network Call Center

is equipped with state-of-the-art telecommunications system with all the necessary features to maintain

our customer services operations performing at optimum capacity 7 days a week, 365 days a year.

The Pharmacy Network Call Center Support Representatives will assist you with information regarding

the patients’ benefit plan, such as eligibility, co-payments, deductibles or co-insurance, clarify alert

messages, confirm a physician’s participation in a provider network, among other information required

for claims management. Keep these numbers at hand for assistance with your day to day claims

management needs.

Contact Information

Mailing Address Call Box 4908 Caguas, Puerto Rico 00726

Location

Highway 1, Km. 33.3, Barrio Bairoa

Angora Industrial Park, Lot # 4 Caguas, Puerto Rico 00725

Pharmacy Network Call Center 24 hours / 7 days a week services

Toll Free numbers T: 1-888-311-6001 / 1-866-411-6001 F: 787-653-2814

Internet: www.mc-21.com Customer Services Monday – Friday 8:00 a.m. – 5:00 p.m. T: 787-286-6032 ext. 3263 E: [email protected]

Prior Authorization Call Center

24 hours / 7 days a week

services

T: 1-866-999-6221 / 1-866-989-6221 Fax Numbers: Use the appropriate fax number according to the health plan provider of the claim being processed.

Triple-S Salud Commercial Plans 1-866-499-4205

BPPR, BMS, MMM & ADAP HIAP 1-866-277-6556

PSG 1-866-894-8197

MAPFRE 1-866-827-8024

http://www.mc-21.com/

mailto:[email protected]


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Claims Processing

Protecting Privileged Health Information

Participating Pharmacies shall always keep in

mind that sending protected health

information (PHI) to an incorrect entity

constitutes a breach of federal HIPAA laws.

MC-21 reiterates that, as a covered entity, the

Pharmacy is responsible of:

1. Verifying the fax number being used before

transmitting PHI. Fax numbers are

constantly changing and using fax numbers

obtained on internet or on a telephone

book is not recommended.

Double-check that the correct fax number has

been entered before initiating a fax

transmission.

Eligibility

Before processing a claim, the Participating Pharmacy shall take steps to gather information that will allow to confirm the eligibility of the plan member. The Pharmacy staff shall request the plan member to present a member identification (ID) card of the pharmacy benefit or healthcare plan AND a valid identification. The cardholders’ identification number and date of birth shall be confirmed before claim processing. The member identification (ID) card presented must be the most current card issued to the p l a n m e m b e r . The plan member’s eligibility can be confirmed through the on-line Claims Processing System or by calling the Pharmacy Network Call Center.

On Line Adjudication System

The Participating Pharmacy is required to

electronically submit all claims using the

current NDPDP format.

MC-21’s electronic billing system is available

for claims processing in real time, 24 hours a

day, 365 days a year. See table 1 for input

codes you will need for the on-line

adjudication process.

Table 1 Input Codes for Online Adjudication

Input Code for Pharmacies MC21

MC21 CORPORATION Bin Number **

010868

Processor Control Number **

Varies according to client

Group Number Varies according to client

Pharmacy ID Number (Qualifier 01) **

NPI #

Member ID Field ** See member’s card

Date of Birth ** Required

Telecommunication Standard

NCPDP Version D.O

Prescriber Information ** NPI #

** Required Fields

It is very important that Participating

Pharmacies consult with its software vendor

on the proper system configuration.


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Manual Claims

If for any reason the pharmacy is unable to process claims electronically, it should submit all information related to services rendered using a Universal Claim Form (UCF). The completed UCF, as well as the electronic claim, should be submitted to MC-21 no later than 60 days after rendering services to the Plan Member. Please be aware that manual claims require prior authorization by MC-21. You may request authorization for a manual claim by calling the Pharmacy Network Call Center. You may obtain a UCF at www.mc-21.com or by calling our Pharmacy Network Call Center.

Clinical DUR Edits

Prior Authorizations (PA)

Prior-Authorization (PA) is a drug utilization

tool employed by direct-based healthcare

organizations which requires that certain

clinical-based criteria be complied with before a

medication is approved. The prior-

authorization process guarantees the

appropriate delivery of medications, while

reducing errors and expenses and encouraging

an adequate use of prescribed medications.

Some prior-authorization criteria require the

patient’s diagnosis and recent lab tests. The

patient’s diagnosis enables to confirm if the

medication is being prescribed according to its

FDA-approved indication or clinical-treatment

guidelines recommendations.

To ensure effective and timely evaluation of

each PA request, the Participating Pharmacy

must submit all required and relevant-to-the-

case documentation.

Steps to an Effective Management of a

Prior Authorization

1. Check that the prescription meets all legal requirements (e.g. patient information, date, instructions to pharmacist, directions to patient, etc.).

2. Provide all relevant information and documentation, including the patient’s name, cardholder member ID, age, weight, etc. In some cases, additional information may be required to perform an evaluation. See table 2 for some examples of additional documentation.

3. Complete the Prior Authorization Request Form. Call our Pharmacy Network Call Center to obtain a PA Request Form or visit www.mc-21.com.

4. Send all documents by fax to the Prior-Authorization Center (refer to page 6 for fax numbers information).

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

Incomplete Prior Authorization Requests

If the Pharmacy does not submit all required

documentation, MC-21 will send the

Pharmacy a written notice indicating the

request is incomplete.




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The Pharmacy will then

have 24 hours to

complete and submit to

MC-21 the missing

information. If the

requested

documentation is not

received within the 24

hour period, MC-21 will

send the Pharmacy a

denial notice stating that the case has been

closed.

Table 2 Examples of Prior Authorization Information

ALERT MESSAGE DOCUMENTATION REQUIRED

PA Required Patient’s Diagnosis

Step Therapy

(e.g.: “Use Omeprazole first”)

Evidence of prior use of first-line drugs (e.g.: medication

profile, letter from physician, etc.)

Duplicate Therapy

(e.g.: Enalapril y Ramipril) Justification to support medical use of both drugs

Confirmation of a Successful Fax

Transmission

If a Pharmacy wants to confirm that faxed

documents have been successfully transmitted to

the Prior-Authorization Center, the following

steps should be performed:

1. Obtain a confirmation from your telephone

services provider validating that your fax line

is free of noise and static.

2. Verify and confirm that your fax line’s

Automatic Number Identification (ANI) is

activated.

3. Review if your fax machine has the option to

add the fax number as part of the reference

information included in the equipment.

4. Write “test-page” on a sheet and fax it to

the Prior-Authorization Center.

5. Once you receive a successful confirmation,

send an e-mail and the fax confirmation to

MC-21 ([email protected]) to

let us know that the transmission was

successful.

6. If the test page was not transmitted

successfully, send the test fax confirmation

to [email protected] along with




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the following information: pharmacy name,

NABP/NPI, telephone number to be reached

and name of contact staff.

Dynamic Prior Authorization (DPA)

A Dynamic Prior Authorization (DPA) is an

automatic override process in which a

Participating Pharmacy enters a pre-

determined unique PA code number. A DPA is

used in certain circumstances, such as a

vacation request, dosage change, or during

adverse weather.

At the time of the fill, the Participating

Pharmacy will process the claim using the PA

code number on the on-line Claims Processing

System.

DPA’s apply only to some plan designs and to

some products. These claims, like all other

claims, may be subject to an audit process.

Step Therapy (ST)

The Step Therapy approach requires the use of a first-line medication recommended by treatment clinical guidelines before using 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 use of the first-line medication may be identified automatically by the on-line Claims Processing System. Plus, there are other methods to prove the previous use of first-line medications, such as:

1. A letter from the physician certifying the previous use of first-line medications.

2. A patient’s medications profile provided

by the pharmacy. 3. Evidence provided by the patient that

proves prior use of first-line medications under another health plan contract number or group.

The prescription, a completed Prior Authorization Request Form and available information that evidences the prior use of a first-line medication should be submitted to the Prior Authorization Call Center faxes (refer to page 6 for fax numbers information). Call the Pharmacy Network Call Center if you need further information.

Age Limit (AL)

The Age Limit edit ensures that the prescribed medication is used in the age group in which its safety and efficacy has been proven. For example, a medication that is limited to a pediatric population or for patients over 18 years of age. This drug utilization tool protects those patients from the non-studied population and guarantees access to patients


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within the studied age group population, while helping prevent morbidity and mortality associated with their use.

Medical Specialty Restriction

Some medications require a prescription from a certain medical specialist. In general, these are specialty drugs that need a high level of experience and monitoring by a physician specialized on certain health conditions. Examples: chemotherapies, biological agents.

Quantity Limits (QL)

The Quantity L imit edit limits the amount that may dispensed on a certain drug. The quantity limit is based on the maximum effective dose approved by the FDA and on evidence from clinical trials. A QL edit prevents problems related to drugs misuse. For example, the use of higher than recommended doses which may pose a potential harm to a patient’s health. QL’s can also be applied to prevent inappropriate use of medications with unproven long-term benefits.

Coordination of Benefits

The coordination of benefits, known as COB,

allows an insured person to use two health

plans with pharmacy benefits – a primary plan

and a secondary plan – for one same

prescription.

How will I know that the person has two health

plans with pharmacy benefits?

The insured person informs you, or

The on-line claims adjudication systems

alerts you that the insured patient has an

alternate health plan.

How should I process a claim with COB?

First, process the claim to the insured’s

primary plan. The primary plan informs the

amount it will pay for the claim.

Second, process the claim to the insured’s

secondary plan (BIN#, PCN and Group) using

the same information submitted to the

primary plan - prescription number,

dispensing date, NDC, quantity to be

dispensed, days’ supply and refills.

The allowed values on the “Other Coverage Code”

field are:

2 = Other Coverage Exists: payment collected

3 = Other Coverage Exists: claim no covered

8 = Coordinate Co-Payment (PSG)

The Participating Pharmacy should verify the

suitable system configuration to allow for

processing of COB claims with its software

vendor.

Call the Pharmacy Network Call Center if you

need further assistance.

Drug Interactions

MC-21’s On-line Adjudication System has the

capability of issuing alert messages when

interactions are detected.


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Pharmacy staff should be aware of these

messages and should know where to view

them in the pharmacy claims system.

The alert messages are associated with the

following levels of severity:

Major – 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

available data is poor and conflicting.

Minor interactions are associated to a

limited risk or no clear risk to the

patient.

None – there are no known interactions.

The Pharmacist must decide how to handle

the event, according to the level of severity

of the interaction, and should always

document the action taken.

Major or Moderate Severity – the

Pharmacist must contact the physician to

discuss alternatives such as a change of

the prescribed medication,

discontinuation of one of the drugs

related to the interaction for a short

period of time, a dose adjustment of one

or both drugs, or a change in the time of

the day in which the drugs are

administered, among other measures.

Minor Severity – the Pharmacist may

choose to counsel the patient about the

potential for interactions and advise

him/her to contact their physician if a

problem arises.

The On-line Adjudication System has been

programmed to detect potentially severe drug-

drug interactions for certain drug

combinations. When this occurs, the claim will

be rejected (Rejection Code 88: "Drug-Drug

Interaction use DUR/PPS coding”). There is

process to override a “drug – drug interaction”

rejection. This process will only be used if and

when the prescribing physician or the

pharmacist, based on their clinical judgment,

determine and document that the rejected

drug poses no danger to the health of the

patient and therefore the prescription can be

filled as ordered.

The Pharmacist must document on the

prescription or in the patient’s electronic

record the intervention performed to support

the drug-drug interaction override. This

process is subject to audit.

Refer to the Common Alert Messages section

in this Manual for more information.

Compounds

MC-21 administers pharmacy benefits on behalf of many different plan sponsors. Each individual health insurance plan determines benefit plan design, such as the specific drugs/ingredients covered, cost-sharing and day supply limitations, among other benefit features.

Participating Pharmacies are expected to observe applicable state and federal laws, CMS policies, professional standards and FDA communications when preparing and dispensing compound drugs. For instance,


13

CMS clearly states that for any non-Part D ingredient of the Part D compound, the Part D sponsor’s contract with the pharmacy must prohibit balance billing the beneficiary for the cost of any such ingredient.

The clarification code (option 8 in the on-line claims adjudication system) allows the pharmacy to process a claim for a compound when at least one of the compounds’ ingredients is a covered drug (refer to Circular Letter MC16-015 for processing details).



Flex – 90™ Program

This program allows the health plan member to

receive a 90-days’ supply of maintenance

drugs. The plan member’s participation in this

program can be optional or required, as

defined by the plan benefit design.

Prescriptions for the Flex-90™ program are

acceptable in any of the following forms:

30 days’ supply and X the number of

repetitions – X equals the number of

repetitions needed to complete a 90 day

supply; the maximum allowed is the

original prescription plus five repetitions.

90 days’ supply and X repetitions -

maximum allowed is one repetition.

Common Alert Messages

The following are some of the most frequent

alert messages on the on-line claims

adjudication system.

Code 76—Plan Limitations Exceeded

Alert means that the cost of the submitted

claim is greater than a certain dollar

amount established by the health plan (e.g.

$500, $1,000).

What to do?

Verify possible data entry error for drug

quantity and cost. Modify information, if

necessary.

If information submitted is correct,

complete a Prior Authorization Request

Form and submit it along with the

prescription to the Prior Authorization

Center (refer to page 6 for fax

numbers information).

You may call the Pharmacy Network Call

Center for further assistance.

Code 76—Maximum Days’ Supply of 15 This alert means that the days’ supply or

the quantity of medication in the submitted

claim are greater than those covered by the

insured’s health plan. The maximum days’

supply varies according to the plan design.

For example, some plans have different

maximum days’ supply for maintenance

and acute medications.

What to do? If you need assistance, call the Pharmacy

Network Call Center.


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Code 70—NDC Not Covered, Generic Substitute Required for Payment

This alert means that the coverage may be

Generic Mandatory. You might be

processing an original (brand) medication.

The rejection code indicates that it must be

substituted with a generic version in order

to obtain payment (“Generic Subst.

Required for Payment”).

What to do?

Private/commercial sector plan - verify

the patient’s coverage; it may indicate

Generic Mandatory.

Government related program - verify if

the medication is included in formulary

and if it has been prescribed by an

authorized physician. If so, the alert

means that the medication prescribed

has a generic substitute and that the

original (brand) product is not covered

by the plan.



Code 70—Plan Exclusion Alert means that the medication being claimed may be excluded or limited to a medical specialty.

What to do?

Private/commercial sector plan - verify the patient’s coverage; the medication may be excluded or limited by medical specialty.

Government related program - verify if the medication is included in formulary and if it has been prescribed by an authorized physician.

Code 88—DUR Error A Code 88 message stands for a “refill-too-

soon”.

What to do?

Verify if there may be a data entry error and

correct, if necessary.

Some insurance companies allow pharmacy

staff to enter an override code due to an

upcoming trip/vacation. In such cases,

Pharmacy must submit the prescription,

along with evidence of the upcoming trip to

the Prior Authorization Center (refer to page

6 of this Manual for fax numbers).

Code 88—High Dose Alert This code alerts on doses that exceed the

daily maximum recommended dose.

What to do?

Pharmacists must exercise their clinical

judgment and /or contact the prescriber

to document that the prescribed dose

does not pose a risk to the patient and

that dispensing is appropriate. The

Pharmacist must always document the

intervention that supports the override on

the prescription or in the patient’s

electronic record. This process is subject

to review during a pharmacy audit

process.

Refer to Circular Letter MC14-060 for

details on override codes to process this

claim.

Code 88—Drug-Drug Interactions This rejection code means that a potentially

severe drug-drug interaction has been

detected, and the claim has been rejected.


15

What to do?

There is a process to override the drug-

drug interaction rejection. This process

will only be used if and when the

Pharmacist or Prescriber conclude that

dispensing the drug does not pose a risk to

the patient.

Pharmacists must exercise their clinical

judgment and /or contact the prescriber

to document that the prescribed drug

poses no danger to the patients’ health

and the prescription can be filled as

ordered. The Pharmacist must always

document the intervention on the

prescription or in the patient’s electronic

record.

Refer to Circular Letter TS14-063 for

details on override codes.

Code 77—Discontinued NDC Number

This code alerts about drugs with an inactive

NDC number. MC-21’s on-line claim

adjudication system does not accept claims

for drugs with inactive NDC numbers.

A rejection for this medication does not

mean that the medication is not covered by

the plan, but that it must be processed with

an active NDC number.

What to do?

Call your supplier for information on

available alternatives for inactive NDC

numbers.



Pharmacy Dispute Process

Participating Pharmacies can report

discrepancies or concerns regarding an un-paid

prescription or adjudication situations regarding

a particular claim (e.g. pharmacy tries to re-

process a rejected claim out-side of the allowed

time and receives a “claim-to-old” message) by

filling out a Pharmacy Dispute Form.

Completed forms and required support

documentation should be submitted to the

Pharmacy Services Center by email

([email protected] or fax (787-653-

2814).

MC-21 will evaluate and respond to all

Pharmacy Dispute evaluation requests.

Call our Pharmacy Network Call Center to request a Pharmacy Dispute Form or visit www.mc-21.com.

Maximum Allowable Cost (MAC)

Appeal Process

MC-21’s MAC Price Review Application provides Participating Pharmacies an effective and agile mechanism to request an evaluation of a reimbursement payment on a generic drug. The application also allows pharmacies to revise the status of a submitted price review claim. To initiate a request, the Pharmacy must access the MAC Price Review Tool at https://apps.mc-21.com/MACPR and complete a claim evaluation request. A step-by-step guide on how to use the MAC Price Review application is available by calling the Pharmacy Network Call Center or visiting www.mc-21.com.



https://apps.mc-21.com/MACPR



16

Quality Assurance Programs

MC-21 highly values and encourages

medication safety practices and requires

participating pharmacies to develop and

maintain Quality Assurance (QA) Programs to

ensure that services are appropriate, effective

and efficient, and result in an improved quality

of care of our client’s members.

MC-21 expects Participating Pharmacy

Providers to establish policies to:

1. Confirm the authenticity of the prescription

order.

2. Reasonably verify the identities of the

patient, the prescriber and the caregiver,

when applicable.

3. Ensure environmental standards that

preserve the integrity of the medications

while they are stored and shipped.

4. Ensure proper accounting of controlled

substances.

QA programs should provide a structured,

systematic process to continuously improve

quality of services. It should establish

procedures to uncover potential risks while

promoting ways to reduce susceptibility to

errors, and should include internal medication

error identification and reduction methods to

ensure proper dispensing of medications -

correct drug, dosage, quantity, and treatment

directions to the correct eligible member.

Pharmacists are responsible for applying their

professional judgment regarding the

appropriate drug use.

MC-21 keeps a registry of pharmacies that

have been identified as a potential safety risk

for members. These pharmacies will be

evaluated by the MC-21 Quality Assurance

Committee for corrective action plans and / or

other decisions, as deemed necessary.

Communications to Pharmacy

Network Members

MC-21 will keep Pharmacy Network members

posted with relevant and updated instructions,

notices, information, supplements or

subsequent revisions to this Manual in order to

promote continued standard of care quality.

Communications will be sent to the Pharmacy’s

on-file email address and/or fax - one more

reason to keep your records at MC-21 up-to-

date – and will be available at www.mc-21.com.



17

Pharmacy Services Center MC-21’s Pharmacy Services Center provides its Pharmacy Network members with administrative

support to ensure compliance with applicable policies, regulations and laws and contractual

agreements. This is a continuous, collaborating process that will promote sound business practices and

ensure the upmost quality service standards for our clients’ members.

The Pharmacy Services Center Support Staff will assist you with any questions regarding Pharmacy

Network contracts, requisites for becoming a Pharmacy Network member (Credentialing), and Re-

credentialing process, among other Pharmacy Network issues.

Contact Information

Telephone: 787-286-6032, extensions 3147 and 3111

Monday – Friday 8:00 a.m. – 5:00 p.m.

Fax: 787-653-2856

E-mail: [email protected]

Mail: MC-21 Corporation, Pharmacy Services Department

P.O. Box 4908, Caguas, Puerto Rico 00726

Internet: www.mc-21.com

Credentialing Process

All new petitioning pharmacies will be evaluated to confirm compliance with MC-21’s contracting

requirements such as facilities adequacy, inventory and necessary operational structure to provide

quality service.

In addition, pharmacies must submit all regulatory licenses and permits in accordance with state and

federal law regulations, such as:

Department of Health Pharmacy License

Controlled Substances Licensing (ASSMCA, DEA)

Biological Products License




18

Pharmacists must meet the following requirements:

License from the Pharmacy Board of Puerto Rico

Certification of Continuing Education Registration

Call the Pharmacy Services Center for more details on the credentialing process.

Contracts Terms

The Service Agreement between MC-21 and a

Participant Pharmacy is valid for a two (2) years

period, after which it will continue to renew

automatically for two (2) years terms as long as

the Participant Pharmacy complies with all

credentialing requirements established by laws

and regulations of the Commonwealth of

Puerto Rico.

Re-Credentialing

Through the re-credentialing process, MC-21

corroborates that the Participating Pharmacy

continues to comply with all requirements

stated in the MC-21 Services Agreement

Contract.

As a member of the MC-21’s Pharmacy

Network, providers have the responsibility to

keep track of the validity of its pharmacy’s

licenses, permits and certifications. Copies of

current documentation must be sent to MC-

21’s Pharmacy Services Center to maintain an

updated record.

If renewal of any of the required

documentation in underway, the provider will

submit valid evidence of the renewal process.

The final and official document will be sent to

MC-21 once the renewal process is complete.

Documentation can be submitted by fax (787-

653-2856), by e-mail

([email protected]) or by mail

(MC-21, Pharmacy Services Center, P.O. Box

4908, Caguas, Puerto Rico 00726).

Pharmacies that do not meet the required

criteria will be granted a reasonable period of

time to submit an action plan to correct

findings identified during the re-credentialing

process.

Termination of Services

If a pharmacy decides to cancel the Service

Agreement due to closure of operations or any

other reason, a written notice must be

submitted to MC-21 with at least 60 calendar

days in advance. The Pharmacy Network

Service Agreement establishes the process to

do so.

MC-21 may immediately dismiss a Participating

Pharmacy from its networks if:

the pharmacy’s licenses to dispense medications is suspended or revoked,

the pharmacy’s name appears in CMS exclusion lists,

the pharmacy does not meet the criteria established in the Pharmacy Network Service Agreement

the pharmacy commits fraud, abuse or waste, or

the pharmacy enters into any other illegal conduct or event that could threaten the



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safety of the insured members.

If the pharmacy does not agree with the termination of services determination, it can appeal the decision within (10) days of the deactivation notice. To do so, the pharmacy must submit a written notice explaining the reasons why the deactivation should not take place, and documentation that significantly supports the request.

The pharmacy will receive MC-21’s final determination within five (5) to seven (7) business days. If additional time is needed, the pharmacy will be informed of the expected time in which a final determination is expected. The development and implementation of a corrective action plan could be required to consider the reactivation of the pharmacy.

Updates in Pharmacy Information

Participating Pharmacies should notify the

NCPDP Agency about changes on demographic

information. MC-21’s claim adjudication

system receives NCPDP data files containing

information on new pharmacies and updates

for existing pharmacies. Since this information

is used for payments and important

notifications, pharmacies need to make sure

their NCPDD information is always up to date.

Changes in pharmacy’s contact information

(address, telephone, fax, e-mails, etc.) should

be notified to MC-21’s Pharmacy Services

Center in writing. You can request a Pharmacy

Information Update Form by calling 787-286-

6032, extensions 3147 and 3111, or by visiting

www.mc-21.com.

Pharmacy Reimbursements

Reimbursement payments for commercial and

government segments are processed bi-weekly.

For the Medicare segment, payments are

processed weekly.

Payment checks include a detailed report on

processed claims during the payment cycle. At

the beginning of each year MC-21 will send

Pharmacy Network members a notice with

payment dates for each cycle.

Record Keeping

Pharmacy Network members shall maintain record of services rendered to Eligible Members. The Pharmacy will retain original prescriptions and the Signature Registry of Eligible Members for a seven (7) year period after the dispensing date of the medication, or as required by applicable laws. For Medicare Part D claims, a 10-years document retention is mandated by CMS (Centers for Medicare and Medicaid). Refer to the MC-21 Pharmacy Services Agreement for state and federal laws requirements on specific record retention.

Non-Discrimination Policy

Pharmacy Network members will not discriminate against any insured member by reason of race, color, ethnicity, gender, marital status, sexual orientation, age or physical or mental disability.

Good Pharmacy Practice

Participating Pharmacies are responsible of ensuring that its pharmacists comply with all



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professional credentials and with good pharmacy practices. MC-21 shall not be liable for claims arising from violations of such practices.

Protected Health Information

Pharmacy Network members shall keep all insured members medical records in strict confidentiality and will disclose such records only:

As established in the Service Agreement contract

If subject to applicable laws and regulations, particularly those contained in the HIPAA Privacy Act, or to orders of any legal court

To another provider who will provide healthcare services to the insured member

If the insured member consents in writing

Pharmacy Audits

The Audit Program main’s objectives are:

ensure compliance with applicable laws and regulations,

ensure compliance with contractual terms between MC-21 and participating pharmacies,

identify, avoid and prevent fraud, waste and abuse,

ensure the validity and accuracy of the claims processed and invoiced to our customers and CMS, and

educate participating pharmacies on the submission of electronic claims and proper documentation.

The Pharmacy Audit Program includes both concurrent and retrospective audits, and can be performed either through on-site or desktop interventions. The Program also provides for Special Audits which respond to irregularities, complaints or disputes referred by insured patients or from another audit process. Any pharmacy that shows suspicious conduct will be reported and irregularities may be subject to penalties, as entitled by the Pharmacy Network Service Agreement and Pharmacy Law. Participating Pharmacies shall keep up-to-date

records on information related to submitted claims. In order to perform a complete audit process MC-21 and/or their duly authorized agents will have access to the Participating Pharmacy’s records, books, registries, files, manuals and electronic prescriptions related to Eligible Members subject to all applicable state and federal laws and regulations governing the confidentiality of such records. Visit www.mc-21.com for access to our Pharmacy Audit Guidelines.



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Fraud, Waste and Abuse (FWA)

MC-21 is committed to avoid, reduce and control the incidence of fraud, waste and abuse pursuant to federal and local laws.

According to current regulations, first tier, downstream and related entities, including pharmacies, must complete appropriate FWA training that complies with CMS and MC-21’s requirements. FWA training must be offered on an annual basis. In an effort to prevent fraud, waste and abuse, MC-21 has developed the following guides for our Participating Pharmacies that provide services to beneficiaries from Medicare Part D. Our goal is to ensure that all pharmacy services providers for MPD programs comply with all the medication processing and dispensing specifications, as established and according to CMS.

What is Fraud?

Fraud is defined as the intentional representation of an individual, who knows 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 inconsistent with acceptable fiscal practices for medicine or businesses. According to federal norms, “the abuse of Medicare is a minor fraud offense. 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 audits 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 of appropriate regulatory agencies. Pharmacies that show deficiencies will be retrained and will be requested to submit an action plan to correct such deficiencies. As required by CMS, MC-21 will establish a follow-up plan with the pharmacy to determine if the corrective actions implemented are resulting as expected.

If similar findings arise in a subsequent intervention, they will be considered and treated as an abuse, and will be referred to MC-21’s Compliance Officer, who will evaluate and determine further actions.

What happens when Fraud, Waste, and

Abuse are identified?

When a pharmacy incurs in fraud, waste, and abuse, MC-21 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 company contracted by CMS for fraud


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management, who will determine course of action. Remember, fraud is a crime punished by law.

How can Fraud be Prevented?

All Participating Pharmacies are responsible for documenting and guaranteeing that processed claims comply with dispensing medications requirements established by CMS and applicable regulatory agencies. They are also responsible for implementing and complying with necessary controls to prevent situations that might be considered abusive or fraudulent. In an additional effort to contest fraud, MC-21’s Pharmacy Providers can notify cases in which they suspect fraud by calling 787-286-6032, extension 3800. Minimum Information Required to Report a Suspicious Fraud Case:

Name of the Pharmacy/Person

Phone number of the person calling

A brief explanation of the situation to be reported

Reporting providers must have the necessary information to report a case. Calls with incomplete information will not be considered for investigation. Each case reported will be treated with the strictest confidentiality. 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 turns 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 and in strict confidentiality and compliance with all privacy parameters 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 it is absolutely necessary during the course of the investigation.

Participating Pharmacy Providers are

responsible of training their staff on Fraud,

Waste and Abuse Prevention. Trainings are

to be offered to all staff, including managers

and directors, on the date of employment,

and then on an annual basis. The Pharmacy

Provider is required to keep copy of the

materials provided in such training and

evidence that the training was offered. Such

information will be provided to MC-21 if or

when requested.

MC-21 provides a complete web-based

training course that pharmacies can use for

training purposes. This course as well as the

FWA Training and Attestation Forms are

available at www.mc-21.com.

Complaints

Pharmacy member complaints or grievances are a means of continually improving the quality of our services. If you have a complaint of services please visit



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www.mc-21.com and complete the Complaints form. Complaints will be handled in a timely manner.

Medicare Part D Compliance

Requirements

Coverage Determination

As established by CMS (CMS-4144-F, April 15,

2011), Participating Pharmacies are required

to notify beneficiaries, in writing, regarding

their right to contact their Medicare plan to

obtain a coverage determination. This notice

has to be hand delivered and in a standard

notification format approved by CMS. The

advice must be performed every time the

pharmacy receives an electronic message

indicating that the claim is not covered.

CMS Exclusion Lists

Participating Pharmacies are required to

have in place policies and procedures for the

reviewing of the exclusions of all CMS

Exclusions Lists such as Office of Inspector

General (OIG / http://www.oig.hhs.gov/),

Excluded Parties List System (EPLS

/http://www. epls.gov), and General

Administration Services (GSA). Pharmacies

must check these lists for each new hire

within the first 90 days of the hire date and

then monthly, to ensure that its employees

are not included in such lists, and therefore,

unable to work with federal programs. The

Pharmacy must keep records to evidence that

the monthly revisions were duly performed.

Such records must be available to MC-21

when requested.

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

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.

Code of Conduct and Ethics

Pharmacy Providers must comply with all

applicable Medicare laws and regulations,

and CMS instructions which include having

compliance policies and procedures in place,

and a standard of conduct and ethics that is

disseminated upon the pharmacy staff.

MC-21 too has developed a Code of Conducts

and Ethics in compliance with these statutes.

This document is available at our website

www.mc-21.com .

Medicare Part D MAC Pricing

In compliance with federal regulations that

establish disclosure and review standards for

prices of prescribed drugs included in the

Medicare MAC list, MC-21 has developed an

on-line application that will provide

Participating Pharmacies access to updated

pricing information on MPD covered drugs.


http://www.oig.hhs.gov/



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Participating Pharmacies shall visit www.mc-

21.com to register and review changes to the

Medicare MAC listing. Refer to circular letter

MD15-030 for more details.

Vaccine Administration

Since January 1st, 2008, the Medicare Part D

program covers the cost of administration of

certain vaccines. As a result, the beneficiary

has a variety of options to receive services

associated with the purchase and

administration of vaccines.

Option 1: Pharmacy dispatches and administers the vaccine

The beneficiary buys the vaccine at a pharmacy and vaccine is administered at this same pharmacy.

To do so, the pharmacy must have duly authorized healthcare professionals to administer such vaccines. The pharmacy will electronically process, in a single transaction, the costs associated with the vaccine and its administration. Contact MC-21’s Pharmacy Services Center for details on processing requirements. 787-286-6032, ext. 3147 or 3111.

Pharmacies interested in participating in the Vaccine Administration Network need to submit evidence of compliance with all

required credentials of healthcare professionals who will administer vaccines at the pharmacy facilities and a duly completed and signed Compensation Attachment Form (MC-21 Compensation Attachment / Medicare Part D Vaccine Administration). For more information on how to become a Vaccine Administration Pharmacy Provider, contact MC-21’s Pharmacy Services Center at 787-286-6032, ext. 3147 or 3111.

Option 2: Pharmacy only dispatches the vaccine

The Pharmacy does not have authorized healthcare professionals to administer vaccines or the beneficiary prefers to buy the vaccine at the Pharmacy and have the vaccine administered by a healthcare professional at another facility. In this case, the pharmacy will process only the cost of the vaccine. The beneficiary will pay administration costs to the healthcare provider and afterwards submit a reimbursement request to the health insurance plan.

Electronic Prescriptions

The 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




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that authenticates the electronic signature of

the prescriber and safeguards 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 and therefore,

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.

Participating Pharmacies 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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MC-21 on the Internet – www.mc-21.com

Visit our webpage for valuable materials and information.

Circular Letters and Updates

FWA General Compliance Training Course

FWA Training Attestation Forms

Medicare Part D MAC Pricing

MC-21 Code of Ethics and Conduct

Pharmacy Dispute Form

Pharmacy Guide for MAC Price Review

Pharmacy Information Update

Prior Authorization Request Form

Universal Claim Form (UFC)


MC-21 Corporation

Highway 1, Km. 33.3, Barrio Bairoa

Angora Industrial Park, Lot # 4

Caguas, Puerto Rico 00725

787-286-6032

www.mc-21.com

All rights reserved.

This Pharmacy Provider Manual and other documents provided to

Participating Pharmacies owned by MC-21, are confidential and remain

the property of MC-21.

The information contained in those documents cannot be released to

third parties without the written consent of MC-21.

Revised December 2017


version 11.7.2016 10:00 a.m. pharmacy network providers manual · version 11.7.2016 10:00 a.m....

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