Upload
others
View
1
Download
0
Embed Size (px)
Citation preview
Version 11.7.2016 10:00 a.m.
Pharmacy Network
Providers Manual
People caring for people…
Pharmacy Network Providers Manual
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
Pharmacy Network Providers Manual
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
Pharmacy Network Providers Manual
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.
Pharmacy Network Providers Manual
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
Pharmacy Network Providers Manual
7
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.
Pharmacy Network Providers Manual
8
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.
Pharmacy Network Providers Manual
9
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
Pharmacy Network Providers Manual
10
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
Pharmacy Network Providers Manual
11
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.
Pharmacy Network Providers Manual
12
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,
Pharmacy Network Providers Manual
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).
Call the Pharmacy Network Call Center if you
need further assistance.
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.
Pharmacy Network Providers Manual
14
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.
Call the Pharmacy Network Call Center if you
need further assistance.
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.
Pharmacy Network Providers Manual
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.
Call the Pharmacy Network Call Center if you
need further assistance.
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.
Pharmacy Network Providers Manual
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.
Pharmacy Network Providers Manual
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
Pharmacy Network Providers Manual
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
Pharmacy Network Providers Manual
19
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
Pharmacy Network Providers Manual
20
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.
Pharmacy Network Providers Manual
21
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
Pharmacy Network Providers Manual
22
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
Pharmacy Network Providers Manual
23
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.
Pharmacy Network Providers Manual
24
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
Pharmacy Network Providers Manual
25
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.
26
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