PHARMACY POLICY – 5.01.529

Management of Opioid Therapy

Effective Date: April 1, 2020

Last Revised: March 19, 2020

Replaces: 5.01.579, 5.01.583

RELATED MEDICAL POLICIES:

None

Select a hyperlink below to be directed to that section.

POLICY CRITERIA | CODING | RELATED INFORMATION

EVIDENCE REVIEW | REFERENCES | HISTORY

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Introduction

Opioids are chemicals that bind to receptors in the brain or body. An opioid can be natural or

synthetic. Opioid medications can be used to manage certain types of pain. Opioids are

prescribed by and in consultation with a licensed healthcare professional. Examples of opioids

are oxycodone, hydrocodone, and fentanyl.

This policy describes when you have to take certain drugs before an opioid can be prescribed.

This policy also describes coverage criteria for quantities of some of the commonly prescribed

opioid medications when prescribed above the allowable limit. Quantity limits in this policy are

based on the maximum dose approved by the U.S. Food and Drug Administration. These dose

limits are the upper range that clinical trials show to provide a balance between safety and

effectiveness. Higher quantities may be approved based on adequate evidence from published

peer reviewed clinical studies, comprehensive medical records history, and the criteria below. It

is very easy to become dependent on opioids, and there is growing public concern about illegal

drug use. Sale of prescription opioids pills as well as heroin is growing rapidly. For this reason, it

is important to prescribe only as many opioid pills as a patient is expected to need. Properly

disposing of unused pills is also important for safety. To learn more about this, ask your

pharmacist or visit the FDA’s drug disposal page at

https://www.fda.gov/forconsumers/consumerupdates/ucm101653.htm.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The

rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for

https://www.fda.gov/forconsumers/consumerupdates/ucm101653.htm

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providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can

be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a

service may be covered.

Policy Coverage Criteria

Note: A copy of medical records history is required when submitting prior authorization

requests for the drugs affected by this policy.

Note: This policy applies to all formulary types across all lines of business (see Definition of

Terms below). As used in this policy, “Formulary” refers to the applicable formulary list

specified in a member’s contract.

Note: Dispensing quantity limits are not intended to apply in circumstances where logistics

may dictate otherwise. These circumstances include but are not limited to member

vacation or business travel, disruption of normal prescription supply chains due to

adverse weather events or other disasters and members living in remote areas where

travel to the nearest pharmacy may sometimes be problematic.

Click on the links below to be directed to that section of the policy:

Short-Acting Opioid Step Therapy

Long-Acting Opioid Step Therapy

Long-Acting Opioid Quantity Limits

Zohydro ER® (hydrocodone ER) and

hydrocodone bitartrate extended-release

OxyContin® (oxycodone ER)

Transmucosal Fentanyl Citrate Products

Short-Acting Opioid Step Therapy

A quantity sufficient for a 7-day supply will be covered without prior authorization. Additional

quantities of BOTH brand and commercially available generic products for greater than a

7-day supply will require coverage review for opioid naïve patients. Opioid naïve is defined as

not having history of any opioid within the past 130 days.

For a list of applicable drugs, see the table in the Related Information section below.

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Short-Acting Opioid Step Therapy

Short-Acting Opioid, Greater Than 7-Day Supply: Medical Necessity This policy does not apply to patients with cancer, sickle cell disease, or those in a

hospice program, end-of-life care, or palliative care.

Requests for more than 7 days of a short-acting opioid may be considered medically

necessary in patients who meet ALL of the following criteria:

• At least one trial of a non-opioid medication (eg, nonsteroidal anti-inflammatory drugs

[NSAIDs], acetaminophen) has provided an inadequate response, or non-opioid

medications are inappropriate according to the prescribing clinician

AND

• The patient’s history of controlled substance prescriptions has been checked within the

last 3 months using the state prescription drug monitoring program (PDMP), unless

unavailable in the state

Note: Exceptions may be medically necessary for certain clinical situations on a case by case

basis including but not limited to traumatic injury or surgeries with extended recovery time

Note: Documentation is required in the form of medical records for all reviews. All approvals

are provided one time only and on a case by case basis.

Long-Acting Opioid Step Therapy

This step therapy is applicable to BOTH brand and commercially available generic

products. This policy does not apply to patients with cancer, sickle cell disease, or those

in a hospice program, end-of-life care, or palliative care.

This step therapy does not apply to methadone, Dolophine® and Methadose™ when

prescribed to treat opioid addiction (Opioid Use Disorder).

For a list of applicable drugs, see the table in the Related Information section below.

Long-Acting Opioid Therapy: Medical Necessity Long-acting opioid may be considered medically necessary in patients with pain severe

enough to require daily, around-the-clock, long-term opioid treatment where patients

meet ALL of the following criteria:

• The patient has chronic pain and is not opioid naïve (opioid naïve is defined as not having

history of any opioid within the past 130 days)

AND

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Long-Acting Opioid Step Therapy

• Patient has a concurrent prescription or previous use of a short-acting opioid

AND

• Non-opioid therapies (eg, non-opioid medications [eg, nonsteroidal anti-inflammatory

drugs {NSAIDs}, tricyclic antidepressants, serotonin and norepinephrine reuptake inhibitors

{SNRIs}, anticonvulsants], exercise therapy, weight loss, cognitive behavioral therapy) have

been optimized and are being used in conjunction with opioid therapy, or they have failed

according to the prescribing clinician

AND

• Treatment plan (including goals for pain and function) is in place and reassessments

(including pain levels and function) are scheduled at regular intervals according to the

prescribing clinician

AND

• The patient’s history of controlled substance prescriptions has been checked within the

last 3 months using the state prescription drug monitoring program (PDMP), unless

unavailable in the state

Note: Documentation is required in the form of medical records for all reviews. Approvals are

provided for one year in duration.

Long-Acting Opioid Quantity Limits

Coverage Guidelines for quantity limits that exceed national guidelines This policy does not apply to patients with cancer, sickle cell disease or those in a

hospice program, end-of-life care, or palliative care.

ALL of the following criteria must be met for short-term approval to be granted:

• Patient is being seen by a board-certified pain specialist as defined by the American Board

of Medical Specialties (ABMS)

AND

• Patient has had trials of 2 or more non-pharmacologic therapies, such as physical therapy,

acupuncture, massage therapy, etc.

AND

• Patient has had trials of 3 or more non-opioid therapies, such as acetaminophen, NSAIDs,

gaba-analogues, tricyclic antidepressants, SNRI’s, etc.

AND

• Patient and the doctor have a pain management contract in place

AND

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Long-Acting Opioid Quantity Limits

Coverage Guidelines for quantity limits that exceed national guidelines • Chart notes must include documentation that the (state-specific) Prescription Drug

Monitoring Program was checked in the last 3 months

AND

• Patient participates in urine drug screening as per frequency documented in the provider’s

chronic opioid therapy plan per medical records OR urine drug screening has been

documented within the last 6 months

Note: Requests may be approved on a case by case basis for a maximum of 3 months to

allow the provider time to reduce the dose to the allowed quantities (as described in the

Long-Acting Opioid Quantity Limit table below).

Note: Documentation is required in the form of medical records for all reviews

Dispensing Quantity Limits

Quantity limits apply to BOTH brand and commercially available generic products.

The following drugs have quantity limits that are of ALL strengths combined in 30 days:

• Arymo® ER, Embeda® ER, Exalgo®, hydromorphone ER, Kadian®, morphine sulfate ER,

Morphabond™ ER, MS Contin®, Nucynta® ER, Opana® ER, and oxymorphone ER

The following dispensing quantity limits are based on the maximum dose recommendations in

the product’s FDA-approved labeling. This information is available for each product at the

manufacturer’s web site or www.fda.gov. Opioid drugs with dispensing quantity limits are listed

in the following table:

Drug Dosage / Strength Quantity Limit Allowed

Without Review

Arymo® ER (morphine sulfate ER) 15 mg, 30 mg, 60 mg ER tablet Limit: 90 tablets per 30 days

Bunavail® (buprenorphine/naloxone) 2.1/0.3 mg, 4.2/0.7 mg buccal

film

Limit: 90 films per fill

Bunavail® (buprenorphine/naloxone) 6.3/1mg mg buccal film Limit: 60 films per fill

Embeda® (morphine sulfate

ER/naltrexone HCl)

20mg/.08mg, 30mg/1.2mg,

50mg/2mg, 60mg/2.4mg,

Limit: 90 capsules per 30 days

http://www.fda.gov/

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Drug Dosage / Strength Quantity Limit Allowed

Without Review

80mg/3.2mg, 100mg/4mg ER

capsule

Exalgo® (hydromorphone HCl ER) 8 mg, 12 mg, 16 mg, 32 mg ER

tablet

Limit: 60 tablets per 30 days

Kadian® (morphine sulfate ER) 10 mg, 20 mg, 30 mg, 40 mg,

50 mg, 60 mg, 80 mg, 100 mg,

200 mg ER capsule

Limit: 90 capsules per 30 days

Morphabond™ ER (morphine sulfate ER) 15 mg, 30 mg, 60 mg, 100 mg

ER tablet

Limit: 60 tablets per 30 days

MS Contin® (morphine sulfate ER) 15 mg, 30 mg, 60 mg, 100 mg,

200 mg ER tablet

Limit: 120 tablets per 30 days

Nucynta® (tapentadol HCl) 50 mg, 75 mg, 100 mg tablet Limit: 181 tablets per fill

Nucynta® ER (tapentadol HCl) 50 mg, 100 mg, 150 mg, 200

mg, 250 mg ER tablet

Limit: 60 tablets per 30 days

Opana® ER (oxymorphone HCl) 5 mg, 7.5 mg, 10 mg, 15 mg, 20

mg, 30 mg, 40 mg tablet

Limit: 90 tablets per 30 days

OxyContin® (oxycodone HCl ER) 10mg, 15 mg, 20 mg, 30 mg, 40

mg ER tablet

Limit: 90 tablets per 30 days

OxyContin® (oxycodone HCl ER) 60 mg, 80 mg ER tablet Limit: 120 tablets per 30 days

Suboxone® (buprenorphine/naloxone) 12/3 mg film Limit: 60 films per fill

Suboxone® (buprenorphine/naloxone) 2/0.5 mg, 4/1 mg, 8/2 mg film

2/0.5 mg, 8/2 mg SL tablet

Limit: 90 films per fill

Zubsolv® (buprenorphine/naloxone) 0.7/0.18 mg, 1.4/0.36 mg,

2.9/0.71 mg, 5.7/1.4 mg SL

tablet

Limit: 90 tablets per fill

Zubsolv® (buprenorphine/naloxone) 8.6/2.1 mg SL tablet Limit: 60 tablets per fill

Zubsolv® (buprenorphine/naloxone) 11.4/2.9 mg SL tablet Limit: 30 tablets per fill

Buprenorphine/naloxone (generic

Suboxone®)

12/3 mg film Limit: 60 films per fill

Buprenorphine/naloxone (generic

Suboxone®)

2/0.5 mg, 4/1 mg, 8/2 mg film

2/0.5 mg, 8/2 mg SL tablet

Limit: 90 films per fill

Hydromorphone ER (generic Exalgo®) 8 mg, 12 mg, 16 mg, 32 mg

tablet

Limit: 60 tablets per 30 days

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Drug Dosage / Strength Quantity Limit Allowed

Without Review

Morphine sulfate ER (generic Kadian®) 10 mg, 20 mg, 30 mg, 50 mg,

60 mg, 80 mg, 100 mg, 200 mg

ER capsule

Limit: 90 capsules per 30 days

Morphine sulfate ER (generic MS

Contin®)

15 mg, 30 mg, 60 mg, 100 mg,

200 mg ER tablet

Limit: 120 tablets per 30 days

Morphine sulfate ER, 24 HR (generic

Avinza®)

30 mg, 45 mg, 60 mg, 75 mg,

90 mg, 120 mg capsule

Limit: 60 capsules per 30 days

Oxycodone HCl ER (generic OxyContin®) 10 mg, 15 mg, 20 mg, 30 mg,

40 mg ER tablet

Limit: 90 tablets per 30 days

Oxycodone HCl ER (generic OxyContin®) 60 mg, 80 mg ER tablet Limit: 120 tablets per 30 days

Oxymorphone ER (generic Opana® ER) 5 mg, 7.5 mg, 10 mg, 15 mg, 20

mg, 30 mg, 40 mg ER tablet

Limit: 90 tablets per 30 days

Long-Acting Opioid Medical Necessity Criteria

Zohydro ER® (hydrocodone bitartrate extended-release) and generic hydrocodone

bitartrate extended-release

Zohydro ER® (hydrocodone bitartrate extended-release) and generic hydrocodone

bitartrate extended-release may be considered medically necessary for the labeled

indication of the management of pain severe enough to require daily, around-the-clock,

long-term opioid treatment and for which alternative treatment options are inadequate.

Zohydro ER® (hydrocodone bitartrate extended-release) and generic hydrocodone

bitartrate extended-release may be covered when ALL of the following criteria are met:

• Treatment of severe chronic pain that requires around the clock opioid pain management

AND

• Documented therapeutic failure of 2 long acting opioids (eg, fentanyl citrate, fentanyl

transdermal, hydromorphone, morphine ER, OxyContin®)

AND

• Patient is not under the age of 19 years old

AND

• Quantity is not over 60 capsules per 30 days

AND

• In the event that a request is received that does not meet criteria for approval but is of a

sufficiently high dose that would require tapering, a 3 month approval may be authorized to

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Long-Acting Opioid Medical Necessity Criteria

allow the provider time to reduce the dose to the allowed quantities above. These requests

may be approved on a case by case basis and are subject to a clinical review for medical

necessity.

In the event where tapering cannot be achieved within a 3-months period, ALL of the

following additional criteria must be met for approval to be granted:

• Patient is being seen by a board-certified pain specialist

AND

• Patient and the doctor have a pain management contract in place

AND

• Patient has had trials of other non-pharmacologic therapies, such as physical therapy,

acupuncture, massage therapy, etc.

AND

• Chart notes must include (state-specific) Prescription Drug Monitoring Program summary

report (last 3 months)

AND

• Patient participates in urine drug screening tests (last 3 months)

Note: First-time approvals will be covered for a period of 3 months (case-dependent). For

continuation of coverage beyond the first 3 months new case review will be required. In addition,

short term approvals may be given on a case by case basis when clinical rationale has been

submitted by a provider indicating that a tapering dose is being attempted, and patient is

expected to reach dosing of 120 Morphine Milligram Equivalent (MME) or less by the end of the 3

months. These requests are subject to a clinical review for medical necessity.

OxyContin® (oxycodone ER)

Extended-release oxycodone (OxyContin®) may be considered medically necessary for the

labeled indication of the management of pain severe enough to require daily, around-the-

clock, long-term opioid treatment and for which alternative treatment options are

inadequate.

Extended release oxycodone (OxyContin®) may be covered when ALL of the following

criteria are met:

• The quantity is not over three tablets per day of OxyContin 10 mg, 15 mg, 20 mg, 30 mg, 40

mg OR four tablets per day of OxyContin 60 mg and 80 mg.

AND

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Long-Acting Opioid Medical Necessity Criteria

• In the event that a request is received that does not meet criteria for approval but is of a

sufficiently high dose that would require tapering, a 3 month approval may be authorized to

allow the provider time to reduce the dose to the allowed quantities above. These requests

may be approved on a case by case basis and are subject to a clinical review for medical

necessity.

In the event where tapering cannot be achieved within a 3-months period ALL of the

following criteria must be met for approval to be granted:

• Medication is being prescribed by or in consultation with a board-certified pain specialist as

defined by the American Board of Medical Specialties (ABMS), OR by a licensed health

professional with extensive training/experience in pain management.

AND

• Patient and the doctor have a pain management contract in place

AND

• Patient has had trials of other non-pharmacologic therapies, such as physical therapy,

acupuncture, massage therapy, etc.

AND

• Chart notes must include (state-specific) Prescription Drug Monitoring Program summary

report (last 3 months)

AND

• Patient participates in urine drug screening tests (last 3 months)

Note: First-time approvals will be covered for a period of 3 months (case-dependent). For

continuation of coverage beyond the first 3 months new case review will be required. In addition,

short term approvals may be given on a case by case basis when clinical rationale has been

submitted by a provider indicating that a tapering dose is being attempted, and patient is

expected to reach ≤120 Morphine Milligram Equivalent (MME) dosing by the end of the 3 months.

These requests are subject to a clinical review for medical necessity.

Note: Quantity limit requests that are the result of a lower strength tablet being used in multiples

that could be achieved with a higher dose tablet (ie, three 20mg tablets versus one 60mg tablet)

will not be approved. In certain circumstances, an approval may be given based on clinical

rationale submitted and would be subject to a review for medical necessity.

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Long-Acting Opioid Medical Necessity Criteria

Transmucosal fentanyl citrate products

Transmucosal fentanyl citrate products (eg, Abstral®, Actiq®, Fentora™, Lazanda®,

Onsolis™, Subsys®) may be considered medically necessary for the treatment of

breakthrough cancer pain in adult patients with compromised oral intake or absorption.

Coding

N/A

Related Information

Short-Acting Opioid, Greater Than 7-Day Supply: Drugs Acetaminophen with codeine: Oral suspension, tablet

• Tylenol® with codeine

Acetaminophen/caffeine/dihydrocodeine: Capsule, tablet

• Trezix™

Aspirin/caffeine/dihydrocodeine: Capsule

• Synalgos®-DC

Belladonna and Opium: Suppository

Benzhydrocodone/acetaminophen

• Apadaz™

• Benzhydrocodone/acetaminophen

Buprenorphine: Injection

• Buprenex®

Butalbital/acetaminophen/caffeine/codeine: Capsule

• Fioricet® with Codeine

Butorphanol: Injection, nasal spray

• Butorphanol Tartrate Novaplus

Carisoprodol/aspirin/codeine: Tablet

Codeine sulfate: Tablet

Codeine/butalbital/aspirin/caffeine: Capsule

• Fiorinal® with Codeine

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Short-Acting Opioid, Greater Than 7-Day Supply: Drugs Hydrocodone/acetaminophen: Oral elixir, oral solution, oral tablet

• Hycet®

• Lorcet®, Lorcet HD®, Lorcet Plus®

• Lortab®, Lortab® Elixir

• Norco®

• Verdrocet®

• Vicodin®, Vicodin ES®, Vicodin HP®

• Xodol®

Hydrocodone/ibuprofen: Tablet

• Ibudone®

• Reprexain™

• Vicoprofen®

• Xylon™

Hydromorphone: Injection, oral solution, rectal suppository, tablet

• Dilaudid®, Simplist Dilaudid®

Ibuprofen/oxycodone: Tablet

Levorphanol: Tablet

Meperidine: Injection, oral solution, oral syrup, tablet

• Demerol®, Meperitab™

Morphine: Injection, oral solution, rectal suppository, tablet

• Duramorph®

• Infumorph®

• Mitigo®

Nalbuphine: Injection

• Nalbuphine HCl Novaplus

Oxycodone: Capsule, injection, oral concentrate, oral solution, tablet

• Oxaydo®

• Oxy IR®

• Roxicodone®

• Roxybond™

Oxycodone/acetaminophen: Tablet, solution

• Endocet®

• Nalocet®

• Oxycodone HCl-Acetaminophen AvPak™

• Percocet®

• Primlev™

Oxycodone/aspirin: Tablet

• Percodan®

Oxymorphone: Tablet

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Short-Acting Opioid, Greater Than 7-Day Supply: Drugs • Opana®

Pentazocine lactate: Injection

• Talwin®

Pentazocine/naloxone: Tablet

Tapentadol: Tablet

• Nucynta®

Tramadol: Oral suspension, tablet

• FusePaq Synapryn™

• Ultram®

Tramadol/acetaminophen: Tablet

• Ultracet®

Long-Acting Opioid Therapy: Drugs Buprenorphine: Buccal film, injection, intradermal implant, transdermal patch

• Belbuca®

• Buprenex®

• Buprenorphine patch

• Butrans®

Fentanyl: Transdermal patch

• Duragesic®

• Fentanyl Transdermal System Novaplus

• Ionsys®

Hydrocodone ER: Capsule, tablet

• Hysingla® ER

• Zohydro® ER

Hydromorphone ER: Tablet

• Exalgo®

Methadone: Injection, oral solution, tablet, tablet for suspension

• Diskets® Dispersible

• Dolophine® HCl

• Methadol HCl Intensol™

• Methadose™

Morphine sulfate ER: Capsule, tablet

• Arymo® ER

• Kadian®

• Morphabond ER™

• MS Contin®

Morphine sulfate and naltrexone ER: Capsule

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Long-Acting Opioid Therapy: Drugs • Embeda®

Oxycodone HCl ER: Tablet

• OxyContin® ER

Oxycodone ER: Capsule

• Xtampza® ER

Oxymorphone ER: Tablet

• Opana® ER

Tapentadol ER: Tablet

• Nucynta® ER

Tramadol ER: Capsule, tablet

• Conzip™

• Ultram® ER

Benefit Application

This policy is managed through the Pharmacy Benefit. It applies to all pharmacy benefit

contracts that include Pharmacy Prior Authorization Edits.

Definition of Terms

Formulary: A formulary is a list of drugs approved by the Pharmacy and Therapeutics

Committee (P&T) for routine use. A well-designed formulary should provide adequate drug

selection to meet the treatment needs of most patients; however, there will always be

exceptional cases where a non-formulary drug may be the best therapeutic choice.

Formulary drug: A formulary drug (also known as a preferred drug) is a drug that is on the

formulary list. Drugs that are not on the list are referred to as non-formulary drugs.

Label: Product label refers to the FDA approved prescribing information that is available for

every legend drug approved for use in the U.S. The label includes indications, contraindications,

recommended dosing, warnings, precautions, side effects, drug interactions, and information on

safety in pregnancy and other special populations. The drug’s pharmacology, pharmacokinetics,

and available dosage forms are also provided. The current format also includes a summary of

the pivotal clinical trials that were submitted to FDA in support of the New Drug Application.

This prescribing information is included as a package insert with the product and is available on

the manufacturer’s web site.

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Quantity limits: A quantity limit is the maximum amount of a medication that may be

dispensed during a given calendar period or at one prescription fill without an exception

request. Dispensing of a larger quantity may be approved, based on individual case review. A

specified larger quantity may be approved when patient-specific circumstances require it, or

when published clinical evidence supports a higher dose protocol.

Evidence Review

Background

Opioid analgesics are commonly used for the management of pain. An estimated 20% of

patients presenting to physician offices with pain symptoms or pain-related diagnoses

(including acute and chronic pain) unrelated to cancer receive an opioid prescription.

Short-acting opioids are indicated for the management of pain severe enough to require an

opioid analgesic. The objective of this quantity limit is to restrict the initial days’ supply of short-

acting opioids to seven days, thus decreasing the quantity dispensed to align with current

guidelines and prevent stockpiling and/or misuse.

The currently available long-acting (due to either an extended-release formulation or a long

half-life [ie, methadone]) opioids are buprenorphine, hydrocodone, hydromorphone,

methadone, morphine sulfate, oxycodone, oxymorphone, tapentadol, and tramadol. All of the

long-acting opioids are indicated for the management of pain severe enough to require daily,

around-the-clock, long-term opioid treatment and for which alternative treatment options are

inadequate. Extended-release opioid dosage forms offer a long duration of effect, reduce

severity of end-of-dose pain, and allow many patients to sleep through the night. Long-acting

products should be prescribed with an immediate-release dosage form, to be used as needed

for breakthrough pain.

Description

Analgesics are used to treat a wide variety of pain syndromes. Traditionally, these have been

classified in three groups: acute pain, chronic cancer pain and chronic pain in non-cancer

patients. Each requires a different approach. In acute pain the goal is to keep the patient

comfortable while avoiding respiratory depression and minimizing the potential of opioid

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dependence. Oncology patients are managed to achieve the best functional balance of

analgesia versus sedation. No maximum dose limits exist in this setting, while chronic non-

cancer pain should be managed with regimens that combine drugs from different

pharmacologic classes to minimize opioid use, eg, antidepressants, NSAIDs or acetaminophen,

muscle relaxants, and anticonvulsants.

Opioid Abuse

Abuse of prescription opioid products is a growing concern. The 2006 National Survey on Drug

Use and Health (NSDUH) found 4.7 million people used a prescription opioid for non-medical

purposes in the month prior to the survey. More than 2 million per year are considered new

illicit users of prescription opioids, a 5-fold increase from the 1980s. For people older than age

12 in 2007, more began illicitly using opioids than marijuana, cocaine, or any other illegal drug.

In addition to abuse of opioids, prescriptions of opioids for pain are also increasing. From 1992

to 2002 prescriptions for opioids increased 154% while the US population increased 13%. Along

with this increase in legitimate and illicit use of opioids has come an increase in ER visits and

deaths due to opioids use.

• The public health surveillance system, Drug Abuse Warning System (DAWN), last published

data on drug related emergency visits from 2008 and found the largest number of ER visits

occurred with oxycodone combinations (105,214) followed by hydrocodone combinations

(89,051), and then methadone (63,629). These numbers have increased dramatically from

2004 with a 152% increase for oxycodone, 123% with hydrocodone, and 73% with

methadone (all p

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While it is clear that use of and adverse events caused by opioids are increasing, the data do not

differentiate between events due to increased legitimate prescribing for pain and those due to

illicit use. Additionally, as the number of total exposures to each drug is unknown, it is difficult

to determine the risk associated with each drug due to lack of a meaningful denominator.

In 2010, the Washington State Legislature passed a statute requiring professional boards to

draft regulations managing high-dose opioid use, clearly recognized as a serious threat to

public health.

Extended-Release Oxycodone

The purpose of the OxyContin® quantity limit is fourfold:

• Reduce unnecessarily large quantities from being dispensed, thereby decreasing the

likelihood of unnecessary tablets remaining in medicine cabinets where relatives and other

visitors to the home could pilfer them.

• Remind prescribers to select a larger tablet size when increasing the dose, rather than

ordering two tablets to be taken at one time.

• Serve as a warning signal is cases where a patient may be using part of the prescription non-

medically, or may be diverting pills for use by others for whom they were not prescribed.

OxyContin® is normally dosed every 12 hours and is designed to be administered as 2 tablets

per day. In individuals with more-rapid-than-normal clearance of oxycodone, or other unusual

clinical circumstances, it is likely that 3 per day would be required. By setting the limit at 3, the

Plan allows for flexibility on the part of practitioners and their patients. OxyContin is available in

tablet sizes of 10, 15, 20, 30, 40, 60, and 80 mg. When the 80mg tablet size is reached, the

patient should be receiving 160mg/day. For cancer patients needing to go beyond this dose, the

4 tablet limit allows a further escalation to 320mg/day before approval of a quantity override

would be needed. Exception for medical necessity will be routinely given when the patient is

being treated for cancer pain and has reached the maximum dosage achievable with 4 tablets

per day.

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Transmucosal Fentanyl

Transmucosal fentanyl agents are potent analgesics approved for the treatment of breakthrough

pain in opioid-treated and tolerant cancer patients. There is no fully published randomized

controlled evidence for use of these products for non-cancer pain at this time.

Availability of longer-term safety/tolerability data with Fentora® is limited. Because life-

threatening respiratory depression could occur at any dose in opioid non-tolerant patients,

Fentora® and Actiq® are contraindicated in the management of acute or postoperative pain,

and for use in opioid non-tolerant patients. A unique adverse event issue identified with use of

Fentora® is application site reactions, including ulceration. Risk is difficult to define, due to the

limited number of patients and duration of exposure to this formulation in clinical trials. This

side effect has the potential to alter the formulation’s absorption characteristics and may

increase risk for serious side effects in some patients. To ensure safety, a cautious approach to

use of either transmucosal fentanyl product is warranted.

Management of chronic severe pain in cancer patients requires the effective use of long-acting

opioids, supplemented with limited doses of a short-acting opioid (rescue medication). Excessive

doses of rescue medication usually indicate suboptimal pain control. This problem can be

alleviated by increasing the fraction of the total daily opioid dose given as long-acting opioid.

2019 Updates

A literature search was conducted from October 1, 2018, to November 1, 2019, and no new

evidence was found that would change this policy. Review of FDA labeling updates for long-

acting opioids in this policy found no new evidence that would change the quantity limits listed

on this policy.

References

1. Silverstein FE, Faich G, Goldstein JL et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for

osteoarthritis and rheumatoid arthritis: The CLASS study: A randomized controlled trial. Celecoxib Long-term Arthritis Safety

Study. JAMA 2000; 284:1247-55.

2. Bombardier C, Laine L, Reicin A et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with

rheumatoid arthritis. (VIGOR) NEJM 2000; 343:1520-28.

3. Lai KC, Chu KM, Hui WM, et al. Celecoxib compared with lansoprazole and naproxen to prevent gastrointestinal ulcer

complications. Am J Med. 2005 Nov;118(11):1271-8.

Page | 18 of 21 ∞

4. Chan FK, Hung LC, Suen BY, et al. Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in

patients with arthritis. NEJM. 2002 Dec 26;347(26):2104-10.

5. Celecoxib plus aspirin versus naproxen and lansoprazole plus aspirin: a randomized, double-blind, endoscopic trial. Clin

Gastroenterol Hepatol. 2007 Oct;5(10):1167-74.

6. Coluzzi PH, Schwartzberg L, Conroy JD et al. Breakthrough cancer pain: a randomized trail comparing oral transmucosal

fentanyl citrate (OFTC®) and morphine sulfate immediate release (MSIR®). Pain. 2001;91:123-130.

7. Payne R, Coluzzi P, Hart L et al. Long-term safety of oral transmucosal fentanyl citrate for breakthrough cancer pain. J Pain

Symptom Manage. 2001;22:575-583.

8. Farrar JT, Cleary J, Rauck R et al. Oral transmucosal fentanyl citrate: randomized, double-blind, placebo controlled trial for

treatment of breakthrough pain in cancer patients. J Natl Cancer Inst. 1998;90:611-616.

9. SAMHSA. Results from the 2006 National Survey on Drug Use and Health: national findings. Rockville, MD: Substance Abuse

and Mental Health Services Administration; 2007b.

10. US Department of Health and Human Services, substance abuse and mental health services administration. Results from the

2007 national survey on drug use and health: national findings. NSDUH Series H-34, DSHS Publication No. SMA 08-4343.

Rockville, MD: Office of Applied Studies, 2008.

11. Webster, L. Update on Abuse-resistant and abuse-deterrent approaches to opioid formulations. Pain Med 2009;10 Suppl

2:S124-S133.

12. Drug Abuse Warning Network, 2011: National Estimates of Drug-Related Emergency Department Visits [online]. Available

online: https://www.samhsa.gov/data/sites/default/files/DAWN2k11ED/DAWN2k11ED/DAWN2k11ED.pdf Accessed

March 2020.

13. Moore TJ, Cohen MR and Furberg CD. Serious adverse drug events reported to the Food and Drug Administration, 1998-2005.

Arch Intern Med 2007;167 (16):1752-1759.

14. Coolen P, Best S, Lima A, et al. Overdose deaths involving prescription opioids among Medicaid enrollees – Washington, 2004-

2007. MMWR 2009;58(42):1171-1175.

15. US Department of Health and Human Services, Substance Abuse and Mental Health Services. Summary report of the meeting:

methadone mortality – a reassessment.

16. Walsh SL, Nuzzo PA, Lofwall MR and Holtman JR. The relative abuse liability of oral oxycodone, hydrocodone, and

hydromorphone assessed in prescription opioid abusers. Drug Alcohol Depend 2008;98(3):191-202.

17. Twycross R, Prommer E, Mihalyo M, Wilcock A. Fentanyl (transmucosal). J Pain Symptom Management 2012;44(1):131-149.

18. Nalamachu S, Rauck R, Dilaha L, Parikh N. Lack of correlation between the dose of fentanyl sublingual spray for breakthrough

cancer pain and the dose of around-the-clock opioid for persistent pain. J Pain 2013;14:S74.

19. Zeppetella G, Davies AN. Opioids for the management of breakthrough pain in cancer patients. Cochrane Database Syst Rev

2013; Oct 21;10:CD004311. doi: 10.1002/14651858.CD004311.pub3.

20. Friedrichsdorf SJ, Postier A. Management of breakthrough pain in children with cancer. J Pain Research 2014;7:117-123.

21. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR

Recomm Rep 2016; 65:1–49. https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm Accessed March 2020.

22. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR

Recommendations and Reports. 2016;65(1):1-49.

23. Nucynta ER extended-release oral tablets [prescribing information]. Titusville, NJ: Janssen Pharmaceuticals, Inc.; October 2014.

24. Embeda extended-release capsules [prescribing information]. Bristol, TN: King Pharmaceuticals, Inc.; October 2014.

25. Kadian capsules [prescribing information]. Parsippany, NJ: Actavis Pharma, Inc.; April 2014.

26. Avinza® capsules [prescribing information]. New York, NY: Pfizer Inc.; April 2014.

https://www.samhsa.gov/data/sites/default/files/DAWN2k11ED/DAWN2k11ED/DAWN2k11ED.pdfhttps://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm

Page | 19 of 21 ∞

27. MS Contin tablets [prescribing information]. Stamford, CT: Purdue Frederick; April 2014.

28. Oramorph SR tablets [prescribing information]. Columbus, OH: Roxane Laboratories; February 2006.

29. OxyContin tablets [prescribing information]. Stamford, CT: Purdue Pharma LP; August 2015.

30. Opana ER tablets [prescribing information]. Malvern, PA: Endo Pharmaceuticals; April 2014.

31. Exalgo extended-release tablets [prescribing information]. Hazelwood, MO: Mallinckrodt Brand Pharmaceuticals, Inc.; June

2015.

32. Zohydro ER extended-release capsules [prescribing information]. San Diego, CA: Zogenix, Inc; January 2015.

33. Hysingla™ ER extended-release tablets [prescribing information]. Stamford, CT: Purdue Phharma L.P.; November 2014.

34. Xtampza ER™ extended-release capsules [prescribing information]. Cincinnati, OH: Patheon Pharmaceuticals; April 2016.

35. Arymo™ ER extended-release tablets [prescribing information]. Stamford, CT: Purdue Pharma LP; January 2017.

36. Conzip extended-release capsules [prescribing information]. Sayreville, NJ: Vertical Pharmaceuticals, LLC; December 2016.

37. Dolophine [prescribing information]. Eatontown, NJ: West-Ward Pharmaceuticals Corp.; January 2017.

38. Belbuca™ buccal film [prescribing information]. Raleigh, NC: BioDelivery Sciences International, Inc.; December 2016.

39. Motheral BR, Henderson R, Cox ER. Plan sponsor savings and member experience with point-of-service prescription step

therapy. Am J Manag Care 2004;10:457-464.

40. Morley CP, Badolato DJ, Hickner J, et al. The impact of prior authorization requirements on primary care physician’s offices:

report of two parallel network studies. J Am Board Fam Med. 2013;26(1):93-95.

41. Funkenstein A, Malowney M, Boyd JW. Insurance Prior Authorization Approval Does Not Substantially Lengthen the Emergency

Department Length of Stay for Patients With Psychiatric Conditions Ann Emerg Med 2013;61(5):596-597.

42. Hoadley JF, Merrell K, Hargrave E, et al. In Medicare Part D plans, low or zero copay and other features to encourage the use of

generics could save billions. Health Aff (Millwood) 2012;31(10):2266-2275.

43. Lu CY, Law MR, Soumerai SB, et al. Impact of prior authorization on the use and costs of lipid-lowering medications among

Michigan and Indiana dual enrollees in Medicaid and Medicare: results of a longitudinal, population-based study. Clin Ther.

2011;33(1):135-44.

44. Law MR, Lu CY, Soumerai SB, et al. Impact of prior authorization on the use and costs of lipid-lowering medications among

Michigan and Indiana dual enrollees in Medicaid and Medicare: results of a longitudinal, population-based study. Clin Ther.

2011;33(1):135-44.

45. 21 CFR 201.5: Labeling Requirements for Prescription Drugs. Adequate Directions for Use. Available at

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=201 Accessed March 2020.

46. Apadaz [prescribing information]. Coralville, IA. KemPharm, Inc.; February 2019.

History

Date Comments 02/08/11 Add to Prescription Drug Section - New Policy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=201

Page | 20 of 21 ∞

Date Comments 12/13/11 Replace Policy – Policy updated with additional approval parameters and dosing

limitation for OxyContin.

11/13/12 Replace policy. A literature search did not indicate the need to update the criteria in

this policy.

03/15/13 Update Related Policies. Add 5.01.542.

07/08/13 Minor Update – Clarification was added to the policy that it is managed through the

member’s pharmacy benefit; this is now listed in the header and within the coding

section.

10/14/13 Replace policy. Medically necessary policy statement for OxyContin updated with new

FDA labeling and stricter FDA indication wording.

04/14/14 Annual review. Policy updated with extended-release hydrocodone (Zohydro ER®) as

medically necessary for the labeled indication of the management of pain severe

enough to require daily, around-the-clock, long-term opioid treatment and for which

alternative treatment options are inadequate.

12/01/14 Update Related Policies. Add 5.01.546.

10/13/15 Annual Review. Policy statements for Cox-II (Celebrex) removed as this medication no

longer requires prior authorization. Title updated, removed “Non-Opiod” as this only

pertained to Celebrex.

02/09/16 Annual Review. Criteria for Zohydro ER removed from Policy Guidelines: concomitant

therapy with CNS depressants or inhibitors of CYP3A4; no history of COPD; and, no

current or recent head injury.

05/01/16 Interim update, approved April 12, 2016. Additional criteria for OxyContin® and

Zohydro® ER quantity limit are included.

01/01/17 Interim Update, approved December 13, 2016. Quantity limit criteria for transmucosal

fentanyl products (TIRFs) has been removed.

06/01/17 Annual Review, approved May 23, 2017. Policy moved into new format. Created

introduction summary and removed the word “preferred” from the coverage criteria

for Zohydro ER. Medical records requirement statement is now included in the policy.

10/01/18 Annual Review, approved September 11, 2018. Significant revision of the policy; added

contents of policy 5.01.579 and 5.01.583 to this policy. Title changed from “Opioid

Analgesics“ to “Management of Opioid Therapy”.

05/01/19 Interim Review, approved April 2, 2019. Added Apadaz™ (benzhydrocodone and

acetaminophen) and benzhydrocodone/acetaminophen to short-acting opioid

therapy. Added buprenorphine patch to long-acting opioid therapy.

07/01/19 Interim Review, approved June 4, 2019. Removed Sublocade and Probuphine under

long-acting opioid therapy.

01/01/20 Annual Review, approved December 10, 2019. No changes to policy statement.

Page | 21 of 21 ∞

Date Comments 03/01/20 Interim Review, approved February 20, 2020. For the Long-Acting Opioid Step Therapy

criteria added an exception for methadone, Dolophine® and Methadose™ when

prescribed to treat opioid addiction. Added generic hydrocodone bitartrate extended-

release to policy.

04/01/20 Interim Review, approved March 19, 2020. Added sickle cell disease as a condition for

when coverage criteria do not apply.

Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The

Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and

local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review

and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit

booklet or contact a member service representative to determine coverage for a specific medical service or supply.

CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA). ©2020 Premera

All Rights Reserved.

Scope: Medical policies are systematically developed guidelines that serve as a resource for Company staff when

determining coverage for specific medical procedures, drugs or devices. Coverage for medical services is subject to

the limits and conditions of the member benefit plan. Members and their providers should consult the member

benefit booklet or contact a customer service representative to determine whether there are any benefit limitations

applicable to this service or supply. This medical policy does not apply to Medicare Advantage.

Discrimination is Against the Law

Premera Blue Cross complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. Premera does not exclude people or treat them differently because of race, color, national origin, age, disability or sex.

Premera: • Provides free aids and services to people with disabilities to communicate

effectively with us, such as: • Qualified sign language interpreters • Written information in other formats (large print, audio, accessible

electronic formats, other formats) • Provides free language services to people whose primary language is not

English, such as: • Qualified interpreters• Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that Premera has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator - Complaints and Appeals PO Box 91102, Seattle, WA 98111 Toll free 855-332-4535, Fax 425-918-5592, TTY 800-842-5357 Email AppealsDepartmentInquiries@Premera.com

You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue SW, Room 509F, HHH Building Washington, D.C. 20201, 1-800-368-1019, 800-537-7697 (TDD) Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

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ລາວ (Lao): ແຈ້ງການນີ້ ນສໍ າຄັນ. ແຈ້ງການນີ້ອາດຈະມີ ນສໍ າຄັນກ່ຽວກັບຄໍ າຮ້ອງສະ ກ ຫຼື ຄວາມຄຸ້ມຄອງປະກັນໄພຂອງທ່ານຜ່ານ Premera Blue Cross. ອາດຈະມີ ນທີ າຄັນໃນແຈ້ງການນີ້. ທ່ານອາດຈະຈໍ າເປັ ນຕ້ອງດໍ າເນີ ນການຕາມກໍ ານົດ ເວລາສະເພາະເພື່ອຮັກສາຄວາມຄຸ້ມຄອງປະກັນສຸຂະພາບ ຫຼື ຄວາມຊ່ວຍເຫຼື ອເລື່ອງ າໃຊ້ າຍຂອງທ່ານໄວ້ . ທ່ານມີ ດໄດ້ ບຂໍ້ ນນີ້ ແລະ ຄວາມຊ່ວຍເຫຼື ອເປັ ນພາສາ ຂອງທ່ານໂດຍບ່ໍ ເສຍຄ່າ. ໃຫ້ໂທຫາ 800-722-1471 (TTY: 800-842-5357).

ູຂໍ້

່

ສໍ ັ

ຈ

ໝ

ສິ

ັ

່

ວ

ຄ

ມ

ມູຮັ

ູມີ ມຂໍ້

ភាសាែខមរ ( ): ឹ

រងរបស់

Premera Blue Cross ។ របែហលជាមាន កាលបរ ិ ឆ ំខានេនៅកងេសចក

េសចកតជី ូ

ជាមានព័ ៌ ៉ ងសំ ់អពី ់ ៉ ប់

នដំ ងេនះមានព័ ី

តមានយា ខាន ំ ទរមងែបបបទ ឬការរា

ណ ត៌មានយ៉ា ំ ់ តងសខាន។ េសចក

េចទស ់ ន ុ ត

ណងេនះ។ អ វការបេញញសមតភាព ដលកណតៃថ ចបាស

កតាមរយៈ

ដំ ឹ នករបែហលជារតូ ច ថ ់ ំ ់ ងជាក់ ់

នដ

ន

ី ន

ូ

អ

ូ

ជ

ជ

ំណឹងេនះរបែហល

នានា េដើ ីនងរកសាទុ ៉ បរងស់ ុ ់ ក ឬរបាក់ ំ

អ

មប ឹ កការធានារា ខភាពរបស ជ

ធនកមានសិ ទទលព័ មានេនះ និ ំ យេនៅកុងភាសារបសទិ ួ ត៌ ងជ ននួ

ន

់ កេដាយម

អ

នអ

យេចញៃថល។ ួ

នអស

ន

ិ

លុ ើ ូ ូយេឡយ។ សមទ ទ រស័ព 800-722-1471 (TTY: 800-842-5357)។

Khmer

ਕਵਰਜ ਅਤ ਅਰਜੀ ਬਾਰ ਮਹ ਤਵਪਰਨ ਜਾਣਕਾਰੀ ਹ ਸਕਦੀ ਹ . ਇਸ ਨ ਿਜਸ ਜਵਚ ਖਾਸ

ਤਾਰੀਖਾ ਹ ਸਕਦੀਆ ਹਨ. ਜੇਕਰ ਤਸੀ ਜਸਹਤ ਕਵਰਜ ਿਰਖਣੀ ਹਵ ਜਾ ਓਸ ਦੀ ਲਾਗਤ ਜਿਵਚ ਮਦਦ ਦ ੇਇਛ ੁਕ ਹ ਤਾਂ ਤਹਾਨ ਅ ਤਮ ਤਾਰੀਖ਼ ਤ ਪਿਹਲਾਂ ਕੁ ਝ ਖਾਸ ਕਦਮ ਚ ਕਣ ਦੀ ਲੜ ਹ ਸਕਦੀ ਹ ,ਤਹੁਾਨ ਮਫ਼ਤ ਿਵਚ ਤ ਆਪਣੀ ਭਾਸ਼ਾ ਿਵ ਚ ਜਾਣਕਾਰੀ ਅਤ ਮਦਦ ਪਾਪਤ ਕਰਨ ਦਾ ਅਿਧਕਾਰ ਹ ,ਕਾਲ 800-722-1471 (TTY: 800-842-5357).

ਪ ਜਾਬੀ (Punjabi): ਇਸ ਨ ਿਟਸ ਿਵਚ ਖਾਸ ਜਾਣਕਾਰੀ ਹ. ਇਸ ਨ ਿਟਸ ਿਵਚ Premera Blue Cross ਵਲ ਤੁਹਾਡੀ

ੰ

ੰ

ੇ ੇ ੇ ੱ ੂ ੋ ੈ ੋੋ ਂ ੁ ੇ ੱ ੋ ੇ ੱੱ ੁ ੱ ੂੁ ੱ ੇ ੱ ੇ ੍ਰ ੈ

ੋ ੰ ੂ ੱ ੁ ੋ ੋ ੈ ੰ

ੋ ੈ ੋ

(Farsi): فارسی فرم بارهدر ھمم اطالعات حاوی است ممکن يهمالعا اين. ميباشد ھمم اطالعات یوحا يهمالعا اين

در ھمم ھای خيتار به باشد.پ رایبستاکنممماش زينهھ اختدپر در مککيا تان بيمهوشش حقظ

Premera Blue Cross طريق از ماش مهبيوشش يا و تقاضا ای پ. يدماين جهتو يهمالعا اين

حق شما. يدشاب داشته اجتياح صیاخ کارھای امانج برای صیمشخ ایھ خيتار به تان، انیمدر ھای کسب برای .نماييد دريافت گانيرا ورط به ودخ زبان به را کمک و اطالعات اين که داريد را اين

استم ) 5357-842-800 مارهباش ماست TTY انکاربر(800-722-1471 مارهش با اطالعات .اييدنم برقرار

้

Polskie (Polish): To ogłoszenie może zawierać ważne informacje. To ogłoszenie może

zawierać ważne informacje odnośnie Państwa wniosku lub zakresu świadczeń poprzez Premera Blue Cross. Prosimy zwrócic uwagę na kluczowe daty, które mogą być zawarte w tym ogłoszeniu aby nie przekroczyć terminów w przypadku utrzymania polisy ubezpieczeniowej lub pomocy związanej z kosztami. Macie Państwo prawo do bezpłatnej informacji we własnym języku. Zadzwońcie pod 800-722-1471 (TTY: 800-842-5357).

Português (Portuguese): Este aviso contém informações importantes. Este aviso poderá conter informações importantes a respeito de sua aplicação ou cobertura por meio do Premera Blue Cross. Poderão existir datas importantes neste aviso. Talvez seja necessário que você tome providências dentro de determinados prazos para manter sua cobertura de saúde ou ajuda de custos. Você tem o direito de obter e sta informação e ajuda em seu idioma e sem custos. Ligue para 800-722-1471 (TTY: 800-842-5357).

Română (Romanian): Prezenta notificare conține informații importante. Această notificare poate conține informații importante privind cererea sau acoperirea asigurării dumneavoastre de sănătate prin Premera Blue Cross. Pot exista date cheie în această notificare. Este posibil să fie nevoie să acționați până la anumite termene limită pentru a vă menține acoperirea asigurării de sănătate sau asistența privitoare la costuri. Aveți dreptul de a obține gratuit aceste informații și ajutor în limba dumneavoastră. Sunați la 800-722-1471 (TTY: 800-842-5357).

Pусский (Russian): Настоящее уведомление содержит важную информацию. Это уведомление может содержать важную информацию о вашем заявлении или страховом покрытии через Premera Blue Cross. В настоящем уведомлении могут быть указаны ключевые даты. Вам, возможно, потребуется принять меры к определенным предельным срокам для сохранения страхового покрытия или помощи с расходами. Вы имеете право на бесплатное получение этой информации и помощь на вашем языке. Звоните по телефону 800-722-1471 (TTY: 800-842-5357).

Fa’asamoa (Samoan): Atonu ua iai i lenei fa’asilasilaga ni fa’amatalaga e sili ona taua e tatau ona e malamalama i ai. O lenei fa’asilasilaga o se fesoasoani e fa’amatala atili i ai i le tulaga o le polokalame, Premera Blue Cross, ua e tau fia maua atu i ai. Fa’amolemole, ia e iloilo fa’alelei i aso fa’apitoa olo’o iai i lenei fa’asilasilaga taua. Masalo o le’a iai ni feau e tatau ona e faia ao le’i aulia le aso ua ta’ua i lenei fa’asilasilaga ina ia e iai pea ma maua fesoasoani mai ai i le polokalame a le Malo olo’o e iai i ai. Olo’o iai iate oe le aia tatau e maua atu i lenei fa’asilasilaga ma lenei fa’matalaga i legagana e te malamalama i ai aunoa ma se togiga tupe. Vili atu i le telefoni 800-722-1471 (TTY: 800-842-5357).

Español ( ): Este Aviso contiene información importante. Es posible que este aviso contenga información importante acerca de su solicitud o cobertura a través de Premera Blue Cross. Es posible que haya fechas clave en este

tiene derecho a recibir esta información y ayuda en su idioma sin costo

aviso. Es posible que deba tomar alguna medida antes de determinadas fechas para mantener su cobertura médica o ayuda con los costos. Usted

alguno. Llame al 800-722-1471 (TTY: 800-842-5357).

Spanish

Tagalog (Tagalog): Ang Paunawa na ito ay naglalaman ng mahalagang impormasyon. Ang paunawa na ito ay maaaring naglalaman ng mahalagang impormasyon tungkol sa iyong aplikasyon o pagsakop sa pamamagitan ng Premera Blue Cross. Maaaring may mga mahalagang petsa dito sa paunawa. Maaring mangailangan ka na magsagawa ng hakbang sa ilang mga itinakdang panahon upang mapanatili ang iyong pagsakop sa kalusugan o tulong na walang gastos. May karapatan ka na makakuha ng ganitong impormasyon at tulong sa iyong wika ng walang gastos. Tumawag sa 800-722-1471 (TTY: 800-842-5357).

ไทย (Thai): ประกาศนมขอมลสาคญ ประกาศนอาจมขอมลทสาคญเกยวกบการการสมครหรอขอบเขตประกน สขภาพของคณผาน Premera Blue Cross และอาจมกาหนดการในประกาศน คณอาจจะตอง ดาเนนการภายในกาหนดระยะเวลาทแนนอนเพอจะรกษาการประกนสขภาพของคณหรอการชวยเหลอท มคาใชจาย คณมสทธทจะไดรบขอมลและความชวยเหลอนในภาษาของคณโดยไม่มคาใชจาย โทร 800-722-1471 (TTY: 800-842-5357)

้ี ี ้ ู ํ ั ้ี ี ้ ู ่ี ํ ั ่ี ั ั ื ัุ ุ ่ ี ํ ี ุ ้ํ ิ ํ ่ี ่ ่ื ั ั ุ ุ ื ่ ื ่ีี ่ ้ ่ ุ ี ิ ิ ่ี ้ ั ้ ู ่ ื ้ี ุ ี ่ ้ ่

Український (Ukrainian): Це повідомлення містить важливу інформацію. Це повідомлення може містити важливу інформацію про Ваше звернення щодо страхувального покриття через Premera Blue Cross. Зверніть увагу на ключові дати, які можуть бути вказані у цьому повідомленні. Існує імовірність того, що Вам треба буде здійснити певні кроки у конкретні кінцеві строки для того, щоб зберегти Ваше медичне страхування або отримати фінансову допомогу. У Вас є право на отримання цієї інформації та допомоги безкоштовно на Вашій рідній мові. Дзвоніть за номером телефону 800-722-1471 (TTY: 800-842-5357).

Tiếng Việt (Vietnamese): Thông báo này cung cấp thông tin quan trọng. Thông báo này có thông tin quan trọng về đơn xin tham gia hoặc hợp đồng bảo hiểm của quý vị qua chương trình Premera Blue Cross. Xin xem ngày quan trọng trong thông báo này. Quý vị có thể phải thực hiện theo thông báo đúng trong thời hạn để duy trì bảo hiểm sức khỏe hoặc được trợ giúp thêm về chi phí. Quý vị có quyền được biết thông tin này và được trợ giúp bằng ngôn ngữ của mình miễn phí. Xin gọi số 800-722-1471 (TTY: 800-842-5357).