pharmacy benefit services policy and procedures purpose - c and o

CONFIDENTIAL & PROPRIETARY INFORMATION OF CATAMARAN INC AND ITS SUBSIDIARIES AND AFFILIATES ‐ EXEMPT FROM DISCLOSURE UNDER FOIA PURSUANT TO 5 USC § 552(b) (4)

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PHARMACY BENEFIT SERVICES POLICY AND PROCEDURES

POLICY TITLE: Transition Process POLICY NUMBER: MS022‐CTRx‐SXC DEPARTMENT: Medicare Products & Services EFFECTIVE DATE: 01/01/2006 POLICY OWNER/SME: Pritesh Patel, Product Manager DEPARTMENT REVIEWED DATES: 05/05/06; 11/29/06; 09/17/09; 03/09/10; 04/15/10; 11/19/10; 01/01/11; 04/14/11; 04/17/11; 11/09/11; 02/17/12; 04/06/12; 09/05/12 APPROVED BY: Amy Guenette, Vice President of Medicare Products & Services APPROVAL DATE: 09/26/2012

PURPOSE: The purpose of this document is to describe a consistent Part D transition process to ensure compliance with all applicable federal and state laws and CMS requirements. DEFINITIONS: Company: Catamaran, Inc., and its subsidiaries and affiliates that provide pharmacy benefit management services. Emergency Fill: After the initial new enrollee transition period, LTC facility residents who are ordered non‐formulary, PA, ST drugs, must receive their medications as ordered without delay. Therefore, Part D plans must cover an emergency supply of these drugs for LTC facility residents as part of their transition process. These emergency supplies of non‐formulary Part D drugs – including Part D drugs that are on a sponsor’s formulary but require prior authorization or step therapy under a sponsor’s utilization management rules – must be for at least 31 days of medication, unless the prescription is written by a prescriber for less than 31 days. Formulary Changes Across Contract Years: Includes drugs that will become Non‐Formulary (no longer covered on the formulary), or drugs that remain on the formulary but have new PA or ST restriction added from one contract year to another. Level‐of‐Care Change: When an enrollee is changing from one treatment setting to another. Examples include, but are not limited to: (1) beneficiaries who enter LTC facilities from hospitals; (2) beneficiaries who are discharged from a


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hospital to a home; (3) beneficiaries who end their skilled nursing facility Medicare Part A stay (where payments include all pharmacy charges) and who need to revert to their Part D plan formulary; (4) beneficiaries who give up hospice status to revert to standard Medicare Part A and B benefits; (5) beneficiaries who end an LTC facility stay and return to the community; and (6) beneficiaries who are discharged from psychiatric hospitals with drug regimens that are highly individualized. Non‐formulary Drug: Part D drugs that are not on the Sponsor’s formulary and that are on the Sponsor’s formulary, but require prior authorization (PA), or step therapy (ST) under a plan’s utilization management rules. Transition Process: (1) the transition of new enrollees into prescription drug plans following the annual coordinated election period; (2) the transition of newly eligible Medicare beneficiaries from other coverage; (3) the transition of individuals who switch from one plan to another after the start of the contract year; (4) Enrollees residing in LTC facilities (including Level of Care Changes and Emergency Fills) and (5) in some cases, current enrollees affected by formulary changes from one contract year to the next.

POLICY: 1. Transition Process in the Retail, Home Infusion, Mail‐Order or I/T/U:

The Part D sponsor must have and implement an appropriate transition process in accordance with CMS requirements for beneficiaries to obtain at least 30 days of medication, unless the prescription is written by a prescriber for less than 30 days, for non‐formulary Part D drugs he or she was taking prior to enrollment (including Part D drugs that are on a plan’s formulary but require prior authorization or step therapy under a plan’s utilization management rules) anytime during the first 90 days of the beneficiary’s enrollment in a plan, beginning on the enrollee’s effective date of coverage. This Transition process applies specifically to:

New enrollees into the PDP on January 1 following the previous year’s annual coordinated election period

Newly eligible Medicare beneficiaries from other coverage in the previous year in another PDP

Individuals who switch from one PDP to another after January 1

In some cases, current enrollees affected by formulary changes from one contract year to the next. (See Formulary Changes Across Contract Years policy.

Enrollees must be allowed to refill a transition supply of a non‐formulary Part D drug if the prescription is dispensed for less than the written amount due to quantity limits for safety purposes or drug utilization edits that are based on approved product labeling. Part D sponsor has systems capabilities that allow them to provide a temporary supply of non‐formulary Part D drugs in order to accommodate the immediate needs of an enrollee, as well as to allow the plan and/or the enrollee sufficient time to work with the prescriber to make an appropriate switch to a therapeutically equivalent medication or the completion of an exception request to maintain coverage of an existing drug based on medical necessity.


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Sponsor will ensure that cost‐sharing for a temporary supply of drugs provided under its transition process will never exceed the statutory maximum co‐payment amounts for low‐income subsidy (LIS) eligible enrollees. For non‐LIS eligible enrollees, the sponsor will ensure that cost‐sharing for a temporary supply of drugs provided under its transition process is based on one of its approved cost‐sharing tiers (if the sponsor has a tiered benefit design) and is consistent with cost‐sharing the sponsor would charge for non‐formulary drugs approved under a coverage exception. Sponsor will ensure that it will apply all transition processes to a brand‐new prescription for a non‐formulary drug if it cannot make the distinction between a brand‐new prescription for a non‐formulary drug and an ongoing prescription for a non‐formulary drug at the point‐of‐sale. Sponsor will extend its transition policy across contract years should a enrollee enroll in a plan with an effective enrollment date of either November 1 or December 1 and need access to a transition supply.

Since certain enrollees may join a plan at any time during the year, this policy is not limited to the first 90 days of the contract year but anytime during the first 90 days of the beneficiary’s enrollment in a plan, beginning on the enrollee’s effective date of coverage..

2. One‐Time Fills

The Part D sponsor has implemented an appropriate transition process in accordance with CMS requirements for beneficiaries to obtain one 30‐day fill.

Part D sponsor has arrangements to continue providing requested drugs on a case‐by‐case basis if an individual’s exception request or appeal has not been processed by the end of the minimum transition period, and until such time that a transition has been made (either through a switch to an appropriate formulary alternative, or a decision on an exception request). Until that transition is made, continuation of drug coverage is required, other than for drugs not covered under Part D. Formulary Changes Across Contract Years: Option 1: Part D sponsor has implemented a transition process for current enrollees consistent with the transition process required for new enrollees. In order to prevent coverage gaps, sponsors choosing this option provides a temporary supply of the requested prescription drug (where not medically contraindicated) and provides enrollees with notice that they must either switch to a drug on the sponsor’s formulary or get an exception to continue taking the requested drug. Option 2: Part D sponsor effectuates a transition for current enrollees prior to Jan 1., and works aggressively to both prospectively transition current enrollees to a therapeutically appropriate formulary alternate and/or complete requests for formulary and tiering exceptions to the new formulary prior to Jan. 1. If an exception is granted, the sponsor authorizes payment prior to Jan 1 of the next contract year. If enrollees have not successfully transitioned to a formulary alternative or had an exception request processed prior to January 1, the sponsor provides a transition supply beginning January 1 until they have effectuated a meaningful transition.


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3. Transition Process for Residents of Long‐Term Care Facilities: The Part D sponsor must have and implement an

appropriate transition process in accordance with CMS requirements for beneficiaries to obtain a 31‐day fill (unless the enrollee presents with a prescription written for less than 31 days, with multiple refills as necessary, up to a 98 day supply during the first 90 days of a beneficiary's enrollment in a plan, beginning on the enrollee's effective date of coverage for non‐formulary Part D drugs in a long‐term care (LTC) setting. Enrollees being admitted to or discharged from a LTC facility, early refill edits are not used to limit appropriate and necessary access to their Part D benefit, and such enrollees are allowed to access a refill upon admission or discharge.

Enrollees must be allowed to refill a transition supply of a non‐formulary Part D drug if the prescription is

dispensed for less than the written amount due to a plan edit (quantity limits). Note: Since certain enrollees may join a plan at any time during the year, this policy must not incorrect limit this

transition to the first 90 days of the contract year. Per CMS, sponsors should consider how to expedite transitions to formulary drugs for enrollees who change

treatment settings due to changes in level of care 4. Emergency Fills in LTC setting outside of transition period while exception request pending: Since LTC residents

must receive their medication without delay, Part D sponsors must cover an Emergency Supply of a Non‐Formulary Part D Drug (or a drug that has PA or ST), even if the enrollee is outside his or her initial 90‐day transition period, while an exception or prior authorization is requested.

The Part D sponsor must provide up to 31 days (unless the prescription is written for less than 31 days) of a non‐

formulary Part D drug to a enrollee in a LTC setting at any time outside of the enrollee’s 90‐day transition period while an exception or prior authorization request is being processed.

This policy applies to both current enrollees in a LTC setting requiring an emergency fill and those entering a LTC

setting from other care settings. 5. Enrollees who remain in same plan they were enrolled in for the prior year and are on a drug as a result of an

exception that was granted in the prior year: Plans have the option of “honoring” exceptions that were granted in the prior year beyond the end of the plan year (i.e., a plan may choose to honor an exception for as long as the enrollee remains in the plan). If a plan is NOT going to honor an exception beyond the end of the plan year, it must notify the enrollee in writing at least 60 days before the end of the prior plan year and either (1) offer to process a prospective exception requests for the current plan year or (2) provide the enrollee with a temporary supply of the requested prescription drug at the beginning of the current plan year and provide the enrollee with notice that they must either switch to a therapeutically appropriate drug on the plan’s formulary or get an exception to continue taking the requested drug.

6. Notice Requirements for Temporary Transition Fills: If the Part D sponsor provides a temporary fill for a non‐

formulary Part D drug under its transition process, it provides the long‐term care resident and outside long‐term


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setting resident with appropriate written notice regarding the transition process within three (3) business days of the temporary fill submitted by provider.

Part D Sponsor sends written notice via U.S. first class mail to enrollee within three business days of adjudication

of a temporary fill. The notice includes (1) an explanation of the temporary nature of the transition supply an enrollee has received; (2) instructions for working with the plan sponsor and the enrollee's prescriber to identify appropriate therapeutic alternatives that are on the plan's formulary; (3) an explanation of the enrollee's right to request a formulary exception; and (4) a description of the procedures for requesting a formulary exception. Sponsor will use the CMS model Transition Notice via the file‐and‐use process or submit a non‐model Transition Notice to CMS for marketing review subject to a 45‐day review.

Sponsor will make available prior authorization or exceptions request forms upon request to both enrollees and

prescribing physicians via a variety of mechanisms, including mail, fax, email, and on plan web sites.

Effective for contracts beginning January 1, 2011, Part D sponsors must ensure that reasonable efforts are made to notify prescribers of enrollees who receive a transition notice after adjudication of a temporary fill (42 C.F.R.§423.120(b)(3)(v)).

7. Communication of Transition Claims and Transition Process: Until such time as alternative transactional coding is

implemented in a new version of the HIPAA standard, Sponsor will promptly implement either: (1) appropriate systems changes to achieve the goals of any additional new messaging approved by the industry through NCPDP to address clarifying information needed to adjudicate a Part D claim (see the 5.1Editorial Document), or (2) alternative approaches that achieve the goals intended in the messaging guidance. Part D Sponsor provides the following system generated message to pharmacy at Point‐of‐Sale;

New Enrollee Transition: Transition supply‐Gen Cov/QL/NF/PA/ST‐XXX‐XXX‐XXXX Formulary Change Across Contract Year: New YYYY Gen1st/QL/NF/PA/ST‐XXX‐XXX‐XXXX LTC LOC Change/ER Fill: If ER Fill or LOC Chng, call XXX‐XXX‐XXXX

Sponsor must make general information about their transition process available for beneficiaries in a similar

manner to information provided on formularies and benefit designs. CMS will make plan transition process information available to enrollees via a required link from Medicare Prescription Drug Plan Finder to sponsor web site and include in pre‐and post‐enrollment marketing materials as directed by CMS.

8. Reporting: Transition Process: Part D sponsor must provide reports to CMS regarding data related to the

transition process as requested. 9. Policy Updates: Part D sponsor will monitor CMS guidance for updates or revisions to current policy as needed. 10. Monitoring: Part D sponsor will monitor and audit operations and compliance on a regular basis.


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PROCEDURES: 1. General Procedures:

Company provides a temporary supply fill anytime during the first 90 days of an enrollee’s enrollment in a Medicare Part D plan (NOT just the first 90 days of the contract year). Company’s adjudication system is very flexible and can be programmed to allow the CMS minimum of one 30‐day fill, as well as allowing the provision of three, 30‐ day fills, or one 90 day supply of non‐formulary Part D drugs and formulary Part D drugs requiring prior authorization or step therapy during the 90 day transition process. Although configuration options allow for a one 90 day supply fill, standard practice is a maximum 30 day supply for retail and 98 day supply for LTC. Company’s EGWP Plans ‐ The standard for Company EGWP plans is to allow 90 days of medication or three 30day fills. Other Plan Sponsors – Each plan sponsor can choose to provide the CMS minimum required transition supply or can provide a greater amount than the required minimum.

I. The first 90 days of the enrollee’s enrollment, also referred to as the new enrollee transition period, include

the following situations:

New enrollees into the plan on January 1 following the previous year’s annual coordinated election period;

Newly eligible Medicare beneficiaries from other coverage in the previous year in another Medicare Part D plan;

Individuals who switch from one Medicare Part D plan to another plan after January 1, including enrollees with an effective enrollment date of either November 1 or December 1 who will have transition periods extend into the following contract year in order to satisfy the required 90 day transition period;

Beneficiaries who are with the plan, then leave, then come back will be treated as new enrollees based on their new effective date of when they returned to the plan;

Beneficiaries who change contracts or PBPs and undergo a formulary change as a result within the same contract qualify for a new enrollee transition period;

Enrollees residing in LTC facilities (reference Section 6 and 7 under PROCEDURES.);

Current enrollees affected by formulary changes between one contract year to the next (See Section 4 under PROCEDURES).

II. All utilization management and non‐formulary edits (not including B vs. D PAs, edits to reject non‐part D drugs, quantity limits for safety reasons, and early refill edits) are overridden during the transition period to allow the multiple fills up to the overall transition day supply limit. Therefore, multiple refills of a transition supply may be obtained up to the maximum allowable days supply of a transition supply.


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III. Enrollees must be allowed to refill a transition supply of a non‐formulary Part D drug if the prescription is dispensed for less than the written amount due to quantity limits for safety purposes or drug utilization edits that are based on approved product labeling.

IV. This temporary transition supply will accommodate the immediate needs of an enrollee and allow the enrollee sufficient time to meet with their prescriber to discuss an appropriate switch to a therapeutically equivalent medication or to submit and receive a decision on a coverage determination and exception request to maintain coverage of an existing drug based on medical necessity reasons.

V. For LIS enrollees, the cost share amount for the transition supply will not exceed the statutory maximum copay amounts. For Non‐LIS enrollees, the cost share for the temporary transition supply will be based on one of the approved cost sharing tiers and will be consistent with the co‐pay that would typically be charged for an approved non‐formulary medication exception. In addition, the copay that would be charged for a PA or ST drug would be consistent with the copay for the CMS approved formulary tier for that product.

Company’s EGWP Plans: EGWP clients that fall under the Company CMS contract have open formularies and all Part D covered products are included on their formulary, these clients will not have non‐formulary exceptions. However, they may have PA and ST exceptions.

VI. Since we are unable to determine if an initial transition supply is a brand‐new prescription for therapy initiation, or an ongoing prescription to continue therapy, all claims will be treated as brand new prescriptions eligible for a transition supply.

VII. Enrollees who receive a transition supply of a PA or ST drugs in the Six Classes of Clinical Concern will be automatically be grandfathered to continue taking that medication throughout their benefit. They will not be considered “new starts” and will not need to go through the coverage determination and exception process in order to continue on their medication. These members will not be sent a transition letter, since they will be able to continue on their therapy without interruption

VIII. All edits will be resolved at the point of service adjudication. No “hard edits” are utilized in order to manage transition supplies. Since the utilization management edits (except B vs. D PA), are overridden to allow the transition fill during first 90 days of the enrollment, there is no need for the Retail, home infusion, safety‐net, or I/T/U pharmacists to enter an override. These claims will pay without any additional input from the submitting pharmacist and therefore the enrollee will never leave the pharmacy without a transition supply.

IX. The P&T Committee reviews this transition policy at least annually to ensure that transition decisions appropriately address situations involving enrollees stabilized on drugs non‐formulary drugs or formulary drugs that require prior authorization or step therapy and which may have risks associated with a change in the prescribed regimen.

X. The procedures for addressing medical review of non‐formulary drug requests, and when appropriate, a process for switching new Part D plan enrollees to therapeutically appropriate formulary alternatives failing an affirmative medical necessity determination is addressed in the Coverage Determinations and Exception Requests P&P.

2. Eligibility for Transition Period

I. All Medicare beneficiaries are identified in the claims processing system (by enrollment date) so the appropriate transition period can be determined.


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The claim adjudication system, will examine the member’s enrollment data determine if the member is a new enrollee, if there is a gap in coverage, or if there is a change in Contract and/or PBP. If the system detects any of these elements, the member is eligible for a 90 day transition period. This 90 day transition period may also cross contract years.

During the transition period, the system allows a transitional fill for all products identified as transition eligible.

When a transition supply claim is paid through the system, pharmacies will be notified via an electronic message informing them that the fill was part of a transition supply. If the claim encounters a valid transitional reject, a message is returned to the pharmacy to indicate the reason for the rejection.

Once the transition period has ended, the system will reject those claims for which the products are non‐formulary or exceed plan limitations.

3. One‐time Fills at End of Transition Period

Company’s EGWP Process, and Process used for Clients in which the Company’s Clinical Call Center reviews Coverage Determinations:

1. Prior to the end of the 90‐day transition period, the prescribing physician must either:

a. Prescribe an alternative formulary medication OR

b. Complete the coverage determination and exception form and return it to Company via fax or mail OR

c. Submit a statement of medical necessity in lieu of the coverage determination and exception form to Company via fax or mail

2. Company Clinical Call Center will review the prior authorization exception request and make a coverage determination. See Coverage Determination and Exception P&P.

3. If the physician does not request an exception for the transition drug, the automated override for the transition drug will expire after the original timeframe (the initial 90‐day transition period).

4. If the enrollee, enrollee’s representative, or physician, has submitted a coverage determination and exception request and the decision is still pending at the end of the 90‐day transition period, a one‐time override will be entered by a Customer Care Professional to allow continuation of therapy while the exception request is being processed through the following process:

a. When a pharmacy or enrollee calls Customer Care regarding a rejected claim after the initial 90‐day transition period expires and the Customer Care Professional determines that the initial exception request is still under review in the Clinical Call Center, Customer Care will enter a one‐time Clinical PA to allow continuation of therapy. Notification will then be provided to the Clinical Call Center that such action has taken place so that they may follow‐up as necessary to complete the review of the exception request.

b. When a pharmacy or enrollee calls Customer Care regarding a rejected claim after the initial 90‐day transition period expires, where the enrollee has been on the medication during the transition period, and the initial exception request has not yet been submitted, Customer Care will enter a one‐time Clinical PA to allow continuation of therapy. Notification will then be provided to the Clinical Call Center that such action has taken place so that they may contact the prescriber to begin the coverage determination and exception process.


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c. Requests beyond the first one‐time extension received by the Customer Care professionals will be sent to the Clinical Call Center and will be reviewed on a case‐by‐case basis for an additional extension while the request proceeds through the coverage determination and exceptions process.

Clients who do not use the Company Clinical Call Center to review Coverage Determinations:

This process would be client specific and defined in each Client’s unique transition policy and procedure. Clients typically define what they would like the Company Customer Care center to do if a pharmacy calls with this type of situation, such as soft transfer the call to the client’s Clinical Call Center, give a one‐time override and transfer the call, or provide the client specific contact information.

4. One time fills for formulary changes across contract years

1. There is a combination of both CMS options for effectuating transitions for enrollees whose drugs are no longer on the formulary, or have had a PA or ST added to them effective January 1 of the next contract year. There is a a transition process for current enrollees consistent with the transition process required for new enrollees; AND notification and encouragement for current enrollees to transition to a therapeutically appropriate formulary alternate and/or complete requests for formulary and tiering exceptions to the new formulary prior to the start of the new contract year (per PDBM, Chapter 6, Section 30.4.5).

2. To ease the volume of member calls and authorization requests as of January 1, enrollees and/or their providers are encouraged to proactively seek non‐formulary exceptions (and other exceptions for drugs that have had utilization management added) prior to the beginning of the next contract year.

3. We support notifying enrollees of formulary changes across contract years using various methods, and the client chooses one or more of these methods to provide ample opportunity for members to proactively seek a non‐formulary exception:

Annual ANOC

EOBs in November and/or December

Online notification tables

Direct enrollee mailings

Client newsletters

Email blasts

4. When such exceptions have been approved, the enrollee will be able to continue on that medication through the end of that contract year (ensuring payment is authorized prior to January 1) and through the next contract year in accordance with the Coverage Determinations and Exception Requests P&P and based on the CMS approved coverage duration defined in the Prior Authorization criteria.

5. If the enrollee, enrollee’s representative, or physician, has submitted a coverage determination and exception request and the decision is still pending on the last day of the contract year, an override for a one‐time temporary 30‐day supply will be entered to ensure there is no coverage gap while proceeding through the exceptions process. Even though the one‐time authorization has been entered, the Clinical Call Center team will still turn‐around the exception request within the CMS required timeframes.


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6. If the enrollee, an appointed representative or the prescribing physician has not requested an exception prior to the end of the contract year, the enrollee, an appointed representative or the prescribing physician must still request a coverage determination exception review as expeditiously as possible.

7. If the enrollee has not successfully transitioned to a formulary alternative by Jan.1, we will provide a transition supply beginning Jan. 1, consistent with the process for new enrollee transitions, by programming the negative formulary changes across contract years (drugs that have utilization management added or have become non‐formulary) to allow the additional transitional fill for current beneficiaries who utilized the drug during the past 120 days.

8. Formulary Changes Across Contract Years can be identified easily by the Customer Care center, Clinical Call Center, and by point‐of‐sale pharmacists based on unique custom electronic messaging on the rejected claim. The message includes text such as “New YYYY PA – call xxx‐xxx‐xxxx”

Company EGWP Process, and Process used for Clients in which the Company Clinical Call Center reviews Coverage Determinations:

9. When the pharmacy or enrollee calls Customer Care regarding a rejected claim for a formulary change across contract years, the Customer Care Professional will complete the following process.

a. The Customer Care Professional will review the enrollee’s prescription claim history to verify if the member received the full transition supply between 1/1 and 3/31. They will also verify if a prior coverage determination request had been received for the enrollee regarding this drug.

b. If the enrollee has received a transition supply and has not yet completed the Coverage Determination & Exceptions request process, the Customer Care Professional will notify the Clinical Call Center of the additional request for a one‐time override. The Clinical Call Center will review the request and will reach out to the prescriber to initiate the coverage determination and exception process. Additional temporary supplies may be granted by the Clinical Call Center on a case‐by‐case basis.

c. If the enrollee has received a one‐time authorization for an additional transitional supply and the Coverage Determination & Exceptions was denied for any reason, a second one‐time authorization will not be provided. The Customer Care Professional then notifies the Clinical Call Center of the additional request for a one‐time override and the Clinical Call Center will reach out to the prescriber to initiate the redetermination process.

d. If the member has NOT received a paid transition supply of that medication, if their prescriber has not yet submitted a request to the Clinical Call Center for an override, or if the PA request was submitted and a decision has not yet been made, Customer Care will enter a one‐time Clinical PA to allow a temporary transition supply. They will then refer the request to the Clinical Call Center to begin the prior authorization process.

Clients who do not use the Company Clinical Call Center to review Coverage Determinations:

The process for when the pharmacy or enrollee calls Customer Care regarding a rejected claim for a formulary change across contract year, for clients that do not use the Company Clinical Call Center would be client specific and addressed based on each Client’s unique transition policy and procedure. Clients typically define how they would like the Company Customer Care center to address these situations.


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5. One‐Time Fills for Unplanned Transitions from Hospital, SNF or Hospice.

For an enrollee leaving a hospital, skilled nursing home or hospice setting (where prescriptions are covered under Medicare Part A or Part B), the discharge list of prescription orders may contain medications that are either non‐formulary or subject to utilization management edits. Please refer to the Level of Care Change definition on Page 1 to review additional examples of Level of Care changes. The Level of Care change automated programming identifies if the member has a change in Patient residence code or a change in pharmacy NPI based on the most recent claim with a different fill date. If a Level of Care Change is identified, the system can be configured to automatically override the following edits at the plan’s discretion to allow the claim to pay:

Refill too soon

Duplicate Prescription

Duplicate Therapy

Non‐Formulary

Prior Authorization (excluding BvsD prior authorizations)

Step Therapy

If the member didn’t have a change identified by a change in Patient residence code, in order to ensure that enrollees do not have a gap in therapy, the pharmacist should call the plans call centerto notify them of the Level of Care Change in order to have an authorization placed in the system allowing the claim to pay. This authorization will address the above edits resulting in a paid claim as determined by the plan.

These authorizations will be entered as one‐time authorizations. However, if the member has subsequent Level of Care Changes, additional one‐time authorizations will be entered to ensure there are no gaps in therapy.

If the rejection is related to a Clinical reason (such as NF, PA, ST) the Clinical Call Center will also be notified to begin the coverage determination and exception process with the prescriber. Company’s contract and Clients that use the Company Clinical Call Center to review Coverage Determinations: If the rejection is related to a Clinical reason (such as NF, PA, ST), the Clinical Call Center will also be notified to begin the coverage determination and exception process with the prescriber. At least quarterly, the Company pharmacy network will be reminded, via fax blast from the Provider Relations department, of the clarification codes to submit for these situations.

6. New Enrollee Transitions for LTC Enrollees:

For LTC beneficiary, the new enrollee transition process is programmed to automatically allow a 31‐day transition supply, unless the prescription is written for less than 31 days, with multiple refills as necessary, to allow up to a 98 day supply of transition medication during the first 90 days of the beneficiary’s enrollment in a plan. LTC enrollees are identified based on the patient residence code submitted on the claim. This process follows the same process as defined in section 1, except that the total day supply of the transition fill allowed is a total of 98 days.


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7. LTC Member Level of Care Changes.

Enrollees admitted to and being discharged from a LTC setting (Level of Care Changes) are NOT subject to "refill too soon" edits. This is to enable these enrollees to fill prescriptions for formulary medications that cannot be taken with them from or into such settings.

In addition, please reference Section 3. Definitions, pg. 1, of this P&P for Level of Care Change definition and additional examples. The Level of Care change automated programming identifies if the member has a change in Patient residence code based on the most recent claim with a different fill date. If a Level of Care Change is identified, the system will automatically override the following edits to allow the claim to pay:

Refill too soon


Duplicate Therapy

Non‐Formulary


Step Therapy

If the member didn’t have a change identified by a change in Patient residence code, in order to ensure that enrollees do not have a gap in therapy, the pharmacist should call the plan’s call center to notify them of the Level of Care Change in order to have an authorization placed in the system to allow the claim to pay. This authorization will address the above edits resulting in a paid claim.

These authorizations will be entered as one‐time authorizations. However, if the member has subsequent Level of Care Changes, additional one‐time authorizations will be entered to ensure there are no gaps in therapy.

Company’s plan and Clients that use the Company Clinical Call Center to review Coverage Determinations: If the rejection is related to a Clinical reason (such as NF, PA, ST), the Clinical Call Center will also be notified to begin the coverage determination and exception process with the prescriber.

At least quarterly, the Company pharmacy network will be reminded, via fax blast from the Provider Relations department, of the clarification codes to submit for these situations.

8. LTC pharmacists must implement the filling of a transition drug supply at the point of sale, including overriding

step therapy and prior authorization system edits if necessary. Since the utilization management edits (not including B vs. D PAs, edits to reject non‐part D drugs, quantity limits for safety reasons, and early refill edits), are overridden to allow the transition fill during first 90 days of the enrollment, which also applies to Residents of LTC facilities, LTC pharmacists to enter an override. These claims will pay without any additional input from the submitting pharmacist and therefore the enrollee will never be without a transition supply. If the first 90 days have passed, then the automated level of care change identification and override process will apply.

9. In order to ensure that enrollees do not have gaps in therapy, the claim adjudication system is programmed to

identify level of care changes based on change in patient residence code on the claim. If a change is detected,


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then the utilization management/non‐formulary rejection will be automatically overridden, the transition supply will pay, and a message will be communicated back to the pharmacy on the paid claim that it was a transition supply.

10. If for any reason a level of care change is not automatically identified and a claim rejects, the pharmacist should

call the Customer Care Center for an authorization to be entered.

11. The Customer Care Professional will enter a one‐time override for the claim to pay. If the rejection is related to a Clinical reason (such as NF, PA, ST) the Clinical Call Center will also be notified to being the coverage determination and exception process with the prescriber.

12. Enrollees in a LTC setting are able to obtain an emergency 31‐day supply at any time after the end of the 90‐day transition period while exception requests are being processed to ensure there is no coverage gap while proceeding through the exceptions process

13. In order to ensure that enrollees do not have a gap in therapy, the pharmacist should call the plan’s call center to notify them of the Emergency Fill in order to have an authorization placed in the system to allow the claim to pay.

This authorization will address the following edits resulting in a paid claim:

Refill too soon


Duplicate Therapy

Non‐Formulary


Step Therapy

These authorizations will be entered as one‐time authorizations. However, if the member has subsequent Emergency Fills, additional one‐time authorizations will be entered to ensure there are no gaps in therapy. Company’s plan and Clients that use the Company Clinical Call Center to review Coverage Determinations: If the rejection is related to a Clinical reason (such as NF, PA, ST), the Clinical Call Center will also be notified to begin the coverage determination and exception process with the prescriber. At least quarterly, the Company pharmacy network will be reminded, via fax blast from the Provider Relations department, of the clarification codes to submit for these situations.

14. Company plan and Clients that use the Company Clinical Call Center to review Coverage Determinations:

In accordance with the exception approval process documented in Company Policy and Procedure, Coverage Determinations and Exception Requests, Company does not approve non‐formulary exception requests based on contract year. Exceptions are approved for a 3‐year period. In addition, we send an approval letter to the enrollee when we grant the exception at the coverage determination or redetermination level, and clearly identify the date that coverage will end in the approval letter.


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15. If the plan decides not to continue coverage under an approved exception into the subsequent plan year for a renewing enrollee, we must send a written notice to the enrollee at least 60 days prior to the end of the plan year, unless:

We sent an approval letter to the enrollee when we granted the exception at the coverage determination or redetermination level, and clearly identified the date that coverage will end in the approval letter; or

We sent an approval letter to the enrollee when we effectuated a reversal of our adverse coverage determination or redetermination decision by the IRE or other appeal entity, and clearly identified the date that coverage will end in the approval letter

And, if the plan is required to send a written notice to the enrollee at least 60 days prior to the end of the plan

year, the notice must:

Explain that the exception will not be extended, and

Provide the date that coverage will end (e.g., on December 31, 20xx).

16. Enrollees are provided with appropriate written transition letter notification (using the CMS model transition notice, Attachment A) regarding their transition supply for any of the reasons indicated in the CMS model transition notice. This notice will include an explanation of the temporary nature of the transition supply along with instructions for working with the plan and the enrollee’s prescriber to determine an appropriate therapeutic formulary alternative. Additionally, the letter template will provide an explanation on the enrollee’s right to request a formulary exception with the procedures on how to pursue that option. One transition letter is generated per drug, so if one drug has exceeded both Prior Authorization and Quantity Limit restrictions, one letter will include both reasons. If a member receives multiple transition fills of different drugs on the same day, a letter will be generated for each drug.

17. Transition supplies are identified by the Adjudication system based on specific indicators on the claim. For new

enrollee transition claims, Formulary Change Across Contract Year transition claims, and Level of Care Emergency Fill transition claims, each claim is stamped with a transition claim indicator. These indicators are used to define the type of transition, and the reason for the transition, as defined in the CMS transition letter template, such as NF, PA, ST, etc.

18. Transition claims identified by the system will be collected in a data file in the regular batch cycle to send to third

party print vendor to merge the claim data into the appropriate letter template. 19. The third party print vendor completes file processing, letter creation, printing and mailing no later than the

following day via USPS first class mail. 20. The entire process of claim identification, letter creation, printing and mailing is completed within three business

days from the time the first transition fill claim is adjudicated per CMS requirements for both beneficiaries in LTC and nonLTC residents.

21. The Transition Notice contains all CMS required information, see Attachment A for Model Transition Notice.


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22. Upon request, Coverage Determination and Exception request forms are available to physicians and enrollees via

fax, email, mail on web sites. 23. Prescribers are provided with notification of a member’s transition fill using reasonable efforts as outlined in CMS

guidance on 12/20/2010. 24. Prescriber notifications include a cover sheet labeled “Prescriber Copy” with key demographic information of the

prescriber and member. Additionally, a cc of the member transition letter is included in the notice to the prescriber.

25. Company uses mail delivery as the method of prescriber notification. Fax delivery is available when a fax number

is supplied.Mailed notices use the address on file. 26. We also have the capability to use a secure web portal to deliver prescriber notification details of transition fills in

lieu of the fax/mail process described above. Prescribers will be notified that one or more of their patients has received a transition fill and directed to a URL where they can log in and view the information communicated in the member’s transition notification letter (for obvious reasons this is much more secure, efficient and accurate).

27. Dispensing pharmacists are notified when a claim paid or rejected due to a transition supply by custom messaging

attached at the drug/strength/dosage form level that defines the type of transition supply (New Enrollee vs. Formulary Change Between Contract Years etc. and for which reason such as NF, PA, ST etc.). Additionally the phone number to call for questions, concerns, and overrides is also included in the messaging.

28. The Company and its processor make any system changes necessary to comply with any new messaging approved by the industry through NCPDP to address clarifying information needed to adjudicate a Part D claim, or alternative approaches that achieve the goals intended in the messaging guidance.

29. General information about the transition process is available to enrollees and providers via the plan website. It is

posted for enrollees within the enrollee restricted area of myCatamaran.com since some plans may offer a richer transition supply benefit than others. The general transition process information is also posted for prescribers and pharmacies to review. Any significant changes to the transition processes related to new CMS requirements are also communicated via fax blast to all network pharmacies when the processes they use to submit claims are affected.

30. S8841, the Company PDP contract with CMS, does not participate in the Medicare Prescription Drug Plan Finder

process since we do not market to individuals and are an 800 series plan; therefore, a link from the Plan Finder web site is not required.

31. Company completes the annual transition policy attestation process in HPMS as well as submits this P&P to CMS for review and approval on an annual basis. For Plan Sponsors who must submit their own P&P and complete their own contract attestation, Company provides the most recently approved version of the Company transition P&P to those Plan Sponsors for review. In addition, Company continues to monitor all CMS guidance to ensure transition process compliance.


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32. Company will coordinate with internal compliance components to ensure that training is done at least annually for

all staff involved in this work and otherwise as necessary. 33. Training materials will be developed using the latest CMS guidance and this P&P. 34. Staff sign‐in sheets will be kept, detailing the names of staff and the date they completed the training. 35. As necessary, on‐going training and reminders will be used by management to ensure compliance and proactively

address any issues. 36. At least annually, or as frequently as CMS distributes updates, revisions to this P&P will be made with input from

the Compliance Counsel. This includes any policy changes from CMS and any procedural changes within the Part D sponsor.

37. All relevant staff will be kept apprised and current on all policy updates on an ongoing basis. Periodic training will

help ensure adherence to all policy changes. 38. At least annually, Company compliance staff will conduct an internal audit of our processes, operations and

policies to ensure compliance. All results and findings will trigger specific corrective action plans which must be implemented to address the specific deficiency. The audit findings will also be shared with the Compliance Committee at the next meeting.

39. At least quarterly, the Vice President responsible for this area and the appropriate Directors and Managers will

review and discuss in depth current compliance with each of the listed policies in this document. Evidence will be required to document full compliance with the policies, including proof that all procedures stated here are being followed. To the degree applicable, samples of the areas will be reviewed to identify weaknesses or procedural issues. Specifically, for clients who Company completes the fulfillment, we will review a random sampling of copies mailed out along with copies of proof of the actual mailing/delivery. For Part D Plan Sponsors who receive the data file only, we will require that a technical resource review the data extract to ensure accurate and complete data is captured and reported. A full detailed report, including a review of the specific procedures above, and all evidence and documentation will be sent to the Compliance Counsel.

40. Any staff or manager involved in this work is required to notify the Compliance Counsel of any instances of fraud,

waste, abuse or other non‐compliance that is reported or discovered. The Compliance Counsel will respond to such notifications in accordance with other established Policies and Procedures and CMS guidelines.


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Rev Date Contributor Review / Revision Notes

01/01/2011 Scott Dunham Updates made due to new CMS requirements to notify prescribers of member transition fills (HPMS memo dated 12/20/2010).

04/18/2011 Iny Marks Updates were made for the 2012 P&P submission related to transition functionality enhancements as well as letter generation enhancements.

10/31/2011 Iny Marks Updates were made to the 2012 P&P related to ER Fill and LOC Change process updates effective 1/1/12.

11/09/2011 Iny Marks 2012 Transition letter template was added in Attachment A

02/17/2012 Iny Marks Updates were made to reflect the specific P&T Committee reviewing the P&P

04/06/2012 Pritesh Patel Section 6 ‐ Notice Requirement for Temporary Transition Fills is updated to be consistent with lettering process

08/30/2012 Tammy Bennett Updated verbiage to include “Catamaran” as company name; incorporated content into new master policy template.

09/04/2012 Tammy Bennett Updated Model Transition Letter (2012 to 2013 version)

09/26/12 Pritesh Patel

Revision for CY2013 Attestion requirements, removed specific reference to RxClaim and Company when uneccessary. Also removed reference to third party vendor

APPENDIX A ‐ Model 2013 Transition Letter

<Material ID> - <CMS Approval Date> - 1

<Return Address Name> <Return Address 1> <Return Address 2> <Return City>, <Return State> <Return Zip>-<Return Zip2>-<Return Zip3>

<Plan Logo>

<Document Created Date in Month Date, Year>

<Member First Name> <Member Middle Initial>. <Member Last Name> <Member Address> <Member City>, <Member State> <Member Zip> Dear <Member First Name> <Member Middle Initial>. <Member Last Name>: This letter is to inform you that <Plan Name> has provided you with a temporary supply of the following prescription: <Product Name> This drug is either not included on our list of covered drugs (called our formulary) or included on the formulary, but subject to certain limits, as described in more detail further below. Our records indicate that you are a [Insert one or both: new enrollee or current enrollee] affected by formulary changes implemented this year by <Plan Name> and that you are within your first 90 days of coverage for this plan year. [Insert for members who do not reside in an LTC facility: Therefore, in the outpatient setting, <Plan Name> is required to provide at least a 30-day supply unless the prescription is written for less and does not provide for refills]. [Insert for members who reside in a LTC facility: For a resident of a long term care facility, <Plan Name> is required to provide at least a 91 day supply and may be up to a 98 day supply, consistent with the dispensing increment, with refills provided, if needed (unless the prescription is written for less).] It is important that you understand that this is a temporary supply of this drug. Before this supply ends, you should speak to <Plan Name> and/or your physician regarding whether you should change the drug you are currently taking, or request an exception from <Plan Name> to continue coverage of this drug. If you need assistance in requesting an exception, or for more information about our transition policy, please call our <Customer Service/Customer Care/Member Services> at <Customer Service#1>. TTY users should call <TTY number#1>. We are happy to take your calls <hours of operations#1>. Instructions on how to apply for an exception or how to change your current prescription are discussed at the end of the letter. The following is an explanation of why your drug is not covered or is limited under <Plan Name>. Name of Drug: <Name of drug> Date Filled: <Fill Date> Insert for Non-Formulary without Quantity Limit Reason for Notification: This drug is not covered on our formulary. Because you are within your first 90 days of coverage with <Plan Name> for this plan year, [Insert for members who do not reside

<Material ID> - <CMS Approval Date> - 2 -

in an LTC facility: we have provided you with a <Days Supply on filled claim> day supply. The maximum days supply allowed is a 30 day supply, and we will not pay for the drug after the maximum days supply is used unless you obtain a formulary exception from <Plan Name>.] [Insert for members who reside in a LTC facility: we will allow you to refill your prescription until we have provided you with up to a 98 day supply, consistent with the dispensing increment (unless the prescription is written for less). Unless you obtain a formulary exception from <Plan Name>, we will not pay for the drug after the maximum days supply is used.] Insert for Non-Formulary with Quantity Limit Reason for Notification: This drug is not covered on our formulary. In addition, we could not provide the full amount that was prescribed because we limit the amount of this drug that we provide at one time. This is called quantity limits and we impose such limits for safety reasons. Because you are within your first 90 days of coverage with <Plan Name> for this plan year, [Insert for members who do not reside in an LTC facility: we will allow you to refill your prescription until we have provided you with a 30 day supply, but we will not pay for the drug after this maximum days supply is used unless you obtain a formulary exception from <Plan Name>.] [Insert for members who reside in a LTC facility: we will allow you to refill your prescription until we have provided you with up to a 98 day supply, consistent with the dispensing increment (unless the prescription is written for less). Unless you obtain a formulary exception from <Plan Name>, we will not pay for the drug after the maximum days supply is used.] Insert for Quantity Limit Reason for Notification: This drug is covered on our formulary. However, we could not provide the full amount that was prescribed because of plan quantity limits. We will not provide more than what our quantity limits permit unless you obtain an exception from <Plan Name>. Please contact <Plan Name> to discuss the exception process. Our contact information is located below. Insert for Prior-Authorization Reason for Notification: This drug requires your doctor or other professional who prescribed this drug to satisfy certain requirements before you can fill this prescription at your pharmacy. This is called prior authorization. Because you are within your first 90 days of coverage with <Plan Name> for this plan year, [Insert for members who do not reside in an LTC facility: we have provided you with a <Days Supply on filled claim> day supply. The maximum days supply allowed is a 30 day supply, and we will not pay for the drug after the maximum days supply is used unless you obtain <Plan Name>’s prior authorization or you obtain an exception to the prior authorization from <Plan Name>.] [Insert for members who reside in a LTC facility: we will allow you to refill your prescription until we have provided you with up to a 98 day supply, consistent with the dispensing increment (unless the prescription is written for less). Unless you obtain a prior authorization from <Plan Name>, we will not pay for the drug after the maximum days supply is used.] Insert for Step Therapy Reason for Notification: This drug will be covered only if you first try certain other drugs, as part of what we call a step therapy program. Step therapy is the practice of beginning drug therapy with what we consider to be a safe and effective, lower cost drug before progressing to other more costly drugs. Because you are within your first 90 days of coverage with <Plan Name> for this plan year, [Insert for members who do not reside in an LTC facility: we have provided you with a <Days Supply on filled claim> day supply. The maximum days supply allowed is a 30 day supply, and we will not pay for the drug after the maximum days supply is used unless you try other drugs on our formulary first or you obtain an exception to the step therapy requirement from <Plan Name>.] [Insert for members who


reside in a LTC facility: we will allow you to refill your prescription until we have provided you with up to a 98 day supply, consistent with the dispensing increment (unless the prescription is written for less). Unless you try other drugs on our formulary first or you obtain an exception to the step therapy requirement from <Plan Name>, we will not pay for the drug after the maximum days supply is used.] Insert for Generic First Reason for Notification: This drug will be covered only if you first try a generic version of this drug. Because you are within your first 90 days of coverage with <Plan Name> for this plan year, [Insert for members who do not reside in an LTC facility we have provided you with a <Days Supply on filled claim> day supply. The maximum days supply allowed is a 30 day supply, and we will not pay for the drug after the maximum days supply is used unless you try the generic drug on our formulary first or you obtain an exception to the step therapy requirement from <Plan Name>.] [Insert for members who reside in a LTC facility: we will allow you to refill your prescription until we have provided you with up to a 98 day supply, consistent with the dispensing increment (unless the prescription is written for less). Unless you try the generic drug on our formulary first, or you obtain an exception from <Plan Name>, we will not pay for the drug after the maximum days supply is used.] Insert for Emergency Fill or Level of Care Change with Non-Formulary Reason for Notification: This drug is not covered on our formulary. We will cover this drug for 31 days while you seek to obtain a formulary exception from <Plan Name>. If you are in the process of seeking an exception, we will consider allowing continued coverage until a decision is made. Please contact <Plan Name> for more information regarding our exception process. Our contact information is located below. Insert for Emergency Fill or Level of Care Change with Prior Authorization Reason for Notification: This drug requires prior authorization. We will cover this drug for 31 days while you seek to obtain an exception to the prior authorization from <Plan Name>. Please contact <Plan Name> to discuss the exemption process. Our contact information is located below. Insert for Emergency Fill or Level of Care Change with Step Therapy Reason for Notification: This drug will be covered only if you first try certain other drugs, as part of what we call our step therapy program. Step therapy is the practice of beginning drug therapy with what we consider to be a safe and effective, lower cost drug before progressing to other more costly drugs. We will cover this drug for 31 days while you seek to obtain an exception to the step therapy requirement from <Plan Name>. Please contact <Plan Name> to discuss the exception process. Our contact information is located below. Insert for High Dollar Reason for Notification: We could not provide the full amount that was prescribed because of plan quantity limits. We will not provide more than what our quantity limits permit unless you obtain an exception from <Plan Name>. Please contact <Plan Name> to discuss the exception process. Our contact information is located below. How do I change my prescription? If your drug is not covered on our formulary, or is covered on our formulary but we have placed a prior authorization, step therapy, or quantity limit on it, you can ask us if we cover another drug used to treat your medical condition. If we cover another drug for your condition, we encourage you to ask your


doctor if these drugs that we cover are an option for you. If your doctor tells you that none of the drugs we cover for treating your condition is medically appropriate, you have the right to request an exception from us. You also have the right to request an exception if your doctor tells you that a prior authorization, quantity limit, or other limit we have placed on a drug you are taking is not medically appropriate for treating your condition. How do I request an exception? The first step in requesting an exception is for you to ask your prescribing doctor to contact us. Written requests should be mailed to <Exception Name>, <Exception Address1>, <Exception Address2>, <Exception City>, <Exception State>, <Exception Zip>-<Exception Zip2>-<Exception Zip3>. Telephone requests can be made by calling <Customer Service# 2>. Fax requests can be sent to <FAX# 2 >. Your doctor must submit a statement supporting your request. It may be helpful to take this notice with you to the doctor or submit it to his or her office. The doctor’s statement must indicate that the requested drug is medically necessary for treating your condition because none of the drugs we cover would be as effective as the requested drug or would have adverse effects for you. If the exception involves a prior authorization, quantity limit, or other limit we have placed on that drug, the doctor’s statement must indicate that the prior authorization, or limit, would not be appropriate given your condition or would have adverse effects for you. Once the physician's statement is submitted, we must notify you of our decision no later than 24 hours, if the request has been expedited, or no later than 72 hours, if the request is a standard request. Your request will be expedited if we determine, or your doctor informs us, that your life, health, or ability to regain maximum function may be seriously jeopardized by waiting for a standard request. What if my request is denied? If your request is denied, you have the right to appeal by asking for a review of the prior decision. You must request this appeal within 60 calendar days from the date of our first decision. We accept standard and expedited requests by telephone and in writing. Written requests should be mailed to <Appeal Name>, <Appeal Address 1>, <Appeal Address 2>, <Appeal City>, <Appeal State>, <Appeal Zip>-<Appeal Zip2>-<Appeal Zip3>. Telephone requests can be made by calling <Customer Service# 3>. Fax requests can be sent to <FAX# 3>.

If you need assistance in requesting an exception or for more information about our transition policy (including alternate format or languages regarding this policy), please call <Customer Service/Customer Care/Member Services> at <Customer Service# 4>. TTY users should call <TTY number # 4>. We are available <Hours of Operation4>. Thank you, <Plan Name> Beneficiaries must use network pharmacies to access their prescription drug benefit. Benefits, formulary, pharmacy network, premium and/or copayments/coinsurance may change on January 1, 2014.


<Tagline/Federal Contracting Statement> This information is available for free in other languages. Please contact our <Customer Service/Customer Care/Member Services> number at <Customer Service# 1> for additional information. <Customer Service/Customer Care/Member Services> is available <hours of operations# 1>. TTY users, please call <TTY number #1>. Esta información está disponible de forma gratuita en otros idiomas. Por favor, póngase en contacto con nuestra <Servicio al Cliente/Atención al cliente/Servicios al Miembro> número en <Customer Service# 1> para obtener información adicional. <Servicio al Cliente/ Atención al Cliente/Servicios al Miembro> es disponibles <hours of operations# 1>. Los usuarios de TTY, llame al <TTY number #1>.

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