2017 FECA Bulletins which have previously been issued by the DFEC but have since expired or been superseded by another Bulletin, Circular or inclusion in the FECA Procedure Manual.

Fiscal Year 2017

Bulletin

Subject

FECA Bulletin No. 17-01

Compounded Medication Prescribing Guidelines

FECA Bulletin No. 17-02

Compensation Pay - Consumer Price Index (CPI) Cost-of-Living Adjustments.

FECA Bulletin No. 17-03

Herbal Supplement Prescribing and Authorizing Guidelines under the Federal Employees' Compensation Act (FECA)

FECA Bulletin No. 17-07

Opioid Prescribing Guidelines


Attention: This bulletin has been superseded and is inactive.

FECA BULLETIN NO. 17-01

Issue Date: October 14, 2016


Subject: Compounded Medication Prescribing Guidelines

Background: Medical compounding is the process of combining or altering two or more drugs or their ingredients to create a hybrid that is tailored to the specific need of a patient. Compounding is normally done by licensed physicians or licensed pharmacists with the oversight of the states' boards of pharmacy. The Food and Drug Administration (FDA)–which exercises federal oversight on the quality, safety, and effectiveness of commercially available drugs–does not approve compounded medications.

Advocates of compound medication suggest that compounded drugs are effective in responding to patient-specific needs especially in cases when a standard drug somewhat fails to meet the dosage form, ingredients required to treat the patient, or route of administration. In addition, a patient may be allergic to ingredients such as dyes, gluten, or lactose found in commercially available medications. Compounding allows pharmacists and physicians to create customized formulas that treat the patient while leaving out the allergens. In addition, since every patient is different, and one's medical condition can vary by stage, severity, age, gender, and other variables, a case could be made for an engineered drug to target a patient's specific medical condition(s). Supporters hold that such direct use of compounded drugs on the site of injury or pain removes the need for swallowing, to which some patients are averse, and mitigates the systemic side effects associated with oral intake.

Opponents of compounded medication argue that compounded drugs pose a high risk of sub and super potency since profit-driven manufacturers may be biased in their choice of ingredients in order to maximize the bottom line. Critics also argue that compounded drugs generally suffer from poor quality, adulteration, counterfeiting, misbranding, and the lack of safety and effectiveness enjoyed by FDA approved drugs. In addition, the gap in federal oversight creates room for a menu of differing state guidelines which may be susceptible to exploitation by some industry stakeholders.

Under the Federal Employees' Compensation Act (FECA), the Department of Labor's (DOL) Office of Workers' Compensation Programs (OWCP) may provide to an employee injured while in the performance of duty, the services, appliances, and supplies prescribed or recommended by a qualified physician, which OWCP considers "likely to cure, give relief, reduce the degree or the period of disability, or aid in lessening the amount of the monthly compensation." See 5 U.S.C. 8103.

In accordance with the discretion granted to DOL and delegated to OWCP, OWCP's Division of Federal Employees' Compensation (DFEC) is instituting a new policy and program to monitor and manage the prescription of compounded medications.

Purpose: To provide guidance to claims staff on the use of compounded products, and how to manage cases where a claimant is receiving such a product for any work-related condition. OWCP will now require a Letter of Medical Necessity (LMN) from the claimant's treating physician to authorize any compounded medication. Further, such LMN must be updated no less than every 90 days.

Action: For compounded prescriptions for any work-related condition(s):

  1. Compounded medications now require prior authorization from OWCP. Upon any attempt to fill a compounded prescription without prior authorization, an electronic message will be returned to the pharmacy notifying both the pharmacist and claimant of the LMN requirement. The fill will concurrently be denied.
     
  2. Upon receipt of any LMN for a compounded medication, an initial screening will be performed by the Central Bill Processing Unit (CBP) based on criteria developed by the OWCP Medical Director. Based on such review, the CBP will either generate a request for authorization for review by the claims examiner (CE) or return the LMN to the requesting physician with reasons for rejection1.
     
  3. Upon receiving a compounded medication authorization thread, the CE should review the LMN and any supporting documentation in the case record such as documented allergies and/or swallowing problems. If the justification for the compounded medication in the LMN is fully explained and consistent with the medical evidence of record, the CE may approve the authorization request without further action. In all other situations, the CE should review the record and conduct additional development including contacting the claimant's physician if additional information from that physician is needed. Based on the additional evidence needed to assess the appropriateness of the request, the claims examiner should either refer the claimant for a second opinion medical examination or for a records review by a District Medical Advisor (DMA).
     
  4. If, after conducting a file review and any necessary medical development, the resulting report supports the compounded medication as appropriate, the CE should approve the authorization request.
     
  5. Medical reports that do not support the use of compounded medication should be weighed against any contrary reports of record. If the weight of medical evidence establishes that the use of compounded medication is not appropriate, the CE should advise the employee accordingly and provide a period of no less than 30 days for response including an opportunity to submit additional supporting medical evidence. Following the expiration of such period, the CE should review and evaluate all medical evidence.
     
  6. If a conflict in medical evidence exists, an impartial referee medical evaluation should be scheduled to resolve that conflict. A conflict is created when a report from the employee's physician and the second opinion (or DMA) are of equal weight and reach opposite conclusions2. If no such conflict exists, a final decision should be issued in regards to entitlement to compounded medication.
     
  7. The CE may only authorize up to 90 days of compounded medication (to be filled each 30 days) use with each LMN. Following the expiration of any such authorization, a new LMN is necessary and authorization by the CE will again be required. The form should be submitted within 75 days of the prior LMN to allow for OWCP review. It should not be submitted sooner than 60 days after the submission of the prior LMN.
     
  8. The level of medical development necessary upon receipt of a subsequent LMN will be dependent on the previously established medical evidence of record. However, cases with ongoing compounded medication authorizations should be reviewed by the DMA or through a second opinion medical examination no less than once per year.

Applicability: Appropriate National and District Office personnel.

Disposition: This bulletin is to be retained until incorporated into the Procedure Manual.

 

 

Douglas C. Fitzgerald
Director for
Federal Employees' Compensation

Distribution: All DFEC Staff

1 The claimant (or authorized representative) is entitled to a formal decision on entitlement to compounded medication, following appropriate development, if requested in writing in response to a rejection by the Central Bill Processing Unit. Requests coming from physicians, however, are not subject to that requirement.

2 5 U.S.C. 8123; 20 C.F.R. 10.321(b)

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Attention: This bulletin has been superseded and is inactive.

FECA BULLETIN NO. 17-02

Issue Date: March 15, 2017


Expiration Date: February 28, 2018


Subject: Compensation Pay - Consumer Price Index (CPI) Cost-of-Living Adjustments.

Purpose: To furnish information on the CPI adjustment process for March 1, 2017.

The cost-of-living adjustments granted to a compensation recipient under the FECA are based on the "Consumer Price Index for Urban Wage Earners and Clerical Workers" (CPI-W) figures published by the Bureau of Labor Statistics (BLS). The annual cost of living increase is calculated by comparing the base month from the prior year to the base month of the current year, with the percentage of increase adjusted to the nearest one-tenth of 1 percent. 5 U.S.C. §8146(a) establishes the base month for the FECA CPI as December.

December 2015 had a CPI-W level of 230.791 and the December 2016 level was reported by BLS as 235.390. This means that the new CPI increase, adjusted to the nearest one-tenth of one percent, is 2.0 percent. The increase is effective March 1, 2017, and is applicable where disability or death occurred before March 1, 2016. In addition, the new base month for calculating the future CPI is December 2016.

The maximum compensation rates1, which must not be exceeded, are as follows:

$8,423.50  per month
7,775.56    each four weeks
1,943.89    per week
388.78       per day (for a 5 day week)

Applicability: Appropriate National Office and District Office personnel.

Reference: FECA Consumer Price Index (CPI) Amendment, dated January 6, 1981; Bureau of Labor Statistics Consumer Price Index Publication for December 2015 (USDL-17-0058)

Action: National Office Production staff will update the iFECS CPI tables and recalculate all payment records when the iFECS system is not in use by District Office personnel. This will occur prior to March 1, 2017. The March 4, 2017 check will be paid at the 2016 rate but include the supplemental CPI payment for the period of March 1st to March 4th. The following periodic roll check will reflect the updated 2017 28-day amount. Please note that if there are any cases with fixed gross overrides, there will be no supplemental record created. These cases must be reviewed to determine if CPI adjustments are necessary, and if so a manual calculation will be required. If the gross override payment is in fact eligible for annual CPI increases, the payment plate should be adjusted in the iFECS system to pay as a "Gross Override with CPI."

  1. CPI Minimum and Maximum Adjustments Listings. Form CA-841, Cost-of-Living Adjustments; Form CA-842, Minimum Compensation Rates; and Form CA-843, Maximum Compensation Rates, should be updated to indicate the increase for 2017. Attached to this directive is a complete list of all the CPI increases and effective dates since October 1, 1966 through March 1, 2017, for reference.
  2. Verification of Compensation. If claimants write or call for verification of the amount of compensation paid (possibly for mortgage verification; insurance verification; loan application; etc.), please continue to provide this data in letter form from the district office. Many times a Benefit Statement may not reach the addressee and regeneration of the form is not possible. A letter indicating the amount of compensation paid every four weeks will be an adequate substitute for this purpose.

Disposition: This Bulletin is to be retained in Part 5, Benefit Payments, Federal (FECA) Procedure Manual, until further notice or the indicated expiration date.

1 Per Executive Order signed by President Obama on December 27, 2016.

 

ANTONIO RIOS
Director for
Federal Employees' Compensation

 

Attachment: Cost of Living Adjustments

 

COST-OF-LIVING ADJUSTMENTS
Under 5 USC §8146(a)

EFFECTIVE DATE

RATE

 

EFFECTIVE DATE

RATE

10/01/66
01/01/68
12/01/68
09/01/69

06/01/70
03/01/71
05/01/72
06/01/73
01/01/74
07/01/74
11/01/74
06/01/75
01/01/76
11/01/76
07/01/77
05/01/78
11/01/78
05/01/79
10/01/79

04/01/80
09/01/80
03/01/81
03/01/82
03/01/83
03/01/84
03/01/85
03/01/86
03/01/87
03/01/88
03/01/89

12.5%
3.7%
4.0%
4.4%

4.4%
4.0%
3.9%
4.8%
5.2%
5.3%
6.3%
4.1%
4.4%
4.2%
4.9%
5.3%
4.9%
5.5%
5.6%

7.2%
4.0%
3.6%
8.7%
3.9%
3.3%
3.5%
N/A
0.7%
4.5%
4.4%

 

03/01/90
03/01/91
03/01/92
03/01/93
03/01/94
03/01/95
03/01/96
03/01/97
03/01/98
03/01/99

03/01/00
03/01/01
03/01/02
03/01/03
03/01/04
03/01/05
03/01/06
03/01/07
03/01/08
03/01/09

03/01/10
03/01/11
03/01/12
03/01/13
03/01/14
03/01/15
03/01/16
03/01/17

4.5%
6.1%
2.8%
2.5%
2.5%
2.7%
2.5%
3.3%
1.5%
1.6%

2.8%
3.3%
1.3%
2.4%
1.6%
3.4%
3.5%
2.4%
4.3%
0.0%

3.4%
1.7%
3.2%
1.7%
1.5%
0.3%
0.4%
2.0%

Prior to September 7, 1974, the new compensation after adding the CPI is rounded to the nearest $1.00 on a monthly basis or the nearest multiple of $.23 on a weekly basis ($.23, $.46, $.69, or $.92). After September 7, 1974, the new compensation after adding the CPI is rounded to the nearest $1.00 on a monthly basis or the nearest $.25 on a weekly basis ($.25, $.50, $.75, or $1.00).

compensation rates

Date

New compensation

Date

New compensation

Prior to 09/07/74

.08-.34 = .23
.35-.57 = .46
.58-.80 = .69
.81-.07 = .92

Eff. 11/01/74

.13-.37 = .25
.38-.62 = .50
.63-.87 = .75
.88-.12 = 1.00

ATTACHMENT TO FECA BULLETIN NO. 17 - 02

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Attention: This bulletin has been superseded and is inactive.

FECA BULLETIN NO. 17-03

Issue Date: March 22, 2017


Subject: Herbal Supplement Prescribing and Authorizing Guidelines under the Federal Employees' Compensation Act (FECA)

Background: The U.S. Food and Drug Administration (FDA) "is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation."1 There has been recent concern/interest in the efficacy and safety of dietary supplements.2

The Federal Food, Drug, and Cosmetic Act defines dietary supplements as "a vitamin; mineral; herb or other botanical, amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances."3

"Herbs are a subset of botanical[]" plants, according to the National Institute of Health's Office of Dietary Supplements (NIH ODS).4 The NIH ODS states that "botanicals are not required by federal law to be evaluated for safety and effectiveness."5

The FDA clearly states that dietary supplements, including herbal supplements, "are not intended to treat, diagnose, cure, or alleviate the effects of diseases."6 In alignment and agreement with the FDA, it follows that herbal supplements are not medically necessary to treat, diagnose, cure or alleviate the effects of work-related injuries or illnesses FECA claimants sustain.

The FDA has documented the risks of dietary and herbal supplements.7 Risks associated with some herbal supplements include potentially unidentified ingredients that can be dangerous to claimants' health and safety, and manufacturers not following proper manufacturing processes and failing FDA inspections (leading to contamination and other health and safety issues). The FDA has a running list of drug safety alerts and advisories, which often includes dietary and herbal supplement safety alerts, on its website.8

An example of such a safety alert is a product named "Super Herbs" that was marketed as a weight loss product. Through laboratory testing, the FDA found that the herb, in fact, contained sibutramine and desmethylsibutramine, a substance structurally similar to sibutramine.9 "Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons."10 The FDA, on November 19, 2015, further warned that Super Herbs "may also interact, in life-threatening ways, with other medications a consumer may be taking."11 Similarly, in one example of mislabeling, on November 30, 2015, the FDA requested a company to immediately cease distribution of a product it had mislabeled as a dietary supplement, when in fact it was a synthetic drug that crosses the blood-brain barrier, accumulates in the brain, affects cerebral vascular blood flow, and has a tranquilizing effect.12

An additional safety concern about these products is that herbal supplement manufacturing companies may not adhere to current Good Manufacturing Practice ("cGMP") regulations.13 For example a 2015 peer reviewed scientific study found that "FDA inspections of herbal supplement manufacturing facilities revealed violations of good manufacturing practices in over half of facilities inspected, including unsanitary conditions and lack of product specifications."14

Under the FECA, the Department of Labor's (DOL) Office of Workers' Compensation Programs (OWCP) may provide to an employee injured while in the performance of duty, the services, appliances, and supplies prescribed or recommended by a qualified physician, which OWCP considers "likely to cure, give relief, reduce the degree or the period of disability, or aid in lessening the amount of the monthly compensation." See 5 U.S.C. 8103.

The Act and its implementing regulations at 20 C.F.R. Part 10, Subpart I (20 C.F.R. 10.800) authorizes OWCP's FECA program to set limitations and require pre-authorization for medical services and supplies where deemed necessary.

In accordance with the discretion granted to DOL and delegated to OWCP, OWCP's Division of Federal Employees' Compensation (DFEC) is instituting a new policy for authorizing herbal supplements for work-related illnesses or injuries.

The Program's policy, based upon the scientific justification that is wholly supported by the FDA, lack of pre-market testing of herbal supplements for safety and efficacy, and safety risks demonstrated by FDA inspections, will be to not authorize payment for herbal supplements unless a claimant's treating physician acquires prior authorization by submitting rationalized medical evidence that supports the herbal supplement's safety, effectiveness, and necessity. Resveratrol is an example of a substance OWCP considers to be an herbal supplement and would require prior authorization.

References: 5 U.S.C. § 8103; 5 U.S.C. § 8124 (a)(2); 5 U.S.C. § 8128; 5 U.S.C. § 8145; 5 U.S.C § 8149. See also 20 C.F.R. 10.800-826.

Purpose: To provide guidance to claims staff for authorizing herbal supplements for work-related illnesses or injuries.

Action: When a request for authorization for an herbal supplement is received (which would generally be in the form of a letter from the claimant or the attending physician), the claims examiner (CE) should:

  1. Review the case for a statement of medical necessity from the treating physician supported by a well-rationalized medical explanation that includes:
    • (a) a description of the herbal supplement needed to address effects of the work-related injury or condition, including its safety;
    • (b) specification of the anticipated frequency and/or duration for which authorization is requested;
    • (c) identification of the diagnosis for which the authorization is requested;
    • (d) the physician's rationale, with explanation, as to how authorization of the herbal supplement is medically necessary and expected to be effective in treating the accepted condition; and
    • (e) what non-herbal medical alternatives were considered and why they were rejected.
  2. If the information received is incomplete or the safety, effectiveness, or need for the herbal supplement is in doubt, the CE may:
    • (a) request written clarification from the attending physician;
    • (b) request an opinion from the District Medical Advisor;
    • (c) obtain a second opinion medical examination; and/or
    • (d) in the event there are medical opinions of equal but opposing value between the attending physician and the second opinion/DMA, obtain an impartial referee physician examination to resolve a conflict in medical opinion pursuant to 5 U.S.C. 8123.
  3. If the information received adequately supports the request with particular reference to item one, the CE may recommend authorization of the herbal supplement for up to 90 days. All authorizations for herbal supplements must be accomplished through the District Director (DD) exception process. See FECA Procedure Manual 5-0202.16(a). As noted on the CA 26 Letter of Medical Necessity, herbal supplements cannot be included and authorized in a compound medication through the use of that form.
  4. If, after any necessary development, the weight of medical evidence does not support authorization for the herbal supplement, the claimant should be notified that the herbal supplement is not authorized with appropriate explanation; a formal decision should be offered. If requested by the claimant and/or the authorized representative, the CE should provide a formal decision with appeal rights.

Applicability: Appropriate National and District Office personnel.

Disposition: This bulletin is to be retained until the Procedure Manual is updated.

 

ANTONIO RIOS
Director for
Federal Employees' Compensation


1 What We Do, FDA, http://www.fda.gov/AboutFDA/WhatWeDo/ (last visited June 13, 2016).

2 See Some Imported Dietary Supplements and Nonprescription Drug Products May Harm You, FDA (Mar. 4, 2016), http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm466588.htm; Mixing Medications and Dietary Supplements Can Endanger Your Health, FDA (Oct. 27, 2014), http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm420349.htm.

3 Dietary Supplement Products & Ingredients, FDA, http://www.fda.gov/Food/DietarySupplements/ProductsIngredients/default.htm (last visited June 13, 2016); see also 21 U.S.C. § 321(ff).

4 Botanical Dietary Supplements, NIH ODS (June 24, 2011), https://ods.od.nih.gov/factsheets/BotanicalBackground-HealthProfessional/.

5 Id.

6 FDA 101: Dietary Supplements, FDA (July 15, 2015) https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm050803.htm.

7 See Information for Consumers on Using Dietary Supplements, FDA http://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/default.htm (last visited June 13, 2016).

8 See Safety Alerts & Advisories, FDA, http://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/default.htm (last visited June 13, 2016).

9 Public Notification: Super Herbs Contains Hidden Drug Ingredients, FDA (Nov. 19, 2015), http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm473597.htm.

10 Id.

11 Id.

12 Warning Letter from the FDA to Brandon Sojka (Nov. 30, 015), FDA, available at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm474788.htm.

13 See Current Good Manufacturing Practices (CGMPs) for Dietary Supplements, FDA, http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm079496.htm.

14 Donald M. Marcus, Dietary Supplements: What's in a name? What's in the bottle?, DRUG TESTING & ANALYSIS (Nov. 2, 2015), available at http://onlinelibrary.wiley.com/doi/10.1002/dta.1855/epdf.

 

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Attention: This bulletin has been superseded and is inactive.

FECA BULLETIN NO. 17-07

Issue Date: June 6, 2017


Subject: Opioid Prescribing Guidelines

In 2015, more than 15,000 people died from overdoses involving prescription opioids1. Appropriate and responsible opioid prescribing saves lives and improves patients' quality of life. Opioid usage can impair a worker's ability to return to and maintain meaningful employment. Appropriate pain management involves developing a treatment plan utilizing, wherever possible, available non-narcotic modalities.

The Centers for Disease Control and Prevention (CDC) evaluated several opioid prescribing guidelines (http://www.cdc.gov/drugoverdose/prescribing/common-elements.html) designed to improve patient safety. All of the guidelines are aimed at educating the treating physician to perform the following common elements for those patients being prescribed an opioid product:

  • Conducting a physical exam, pain history, past medical history, and family/social history
  • Conducting urine drug testing, when appropriate
  • Considering all treatment options, weighing benefits and risks of opioid therapy, and using opioids when alternative treatments are ineffective
  • Starting patients on the lowest effective dose
  • Implementing pain treatment agreements
  • Monitoring pain and treatment progress with documentation; using greater vigilance at high doses
  • Using safe and effective methods for discontinuing opioids (e.g., tapering, making appropriate referrals to medication-assisted treatment, substance use specialists, drug rehabilitation programs or other services)
  • Using data from Prescription Drug Monitoring Programs (PDMPs) to identify past and present opioid prescriptions at initial assessment and during monitoring.

Under the Federal Employees' Compensation Act (FECA), the Department of Labor's (DOL) Office of Workers' Compensation Programs (OWCP) may provide to an employee injured while in the performance of duty, the services, appliances, and supplies prescribed or recommended by a qualified physician, which OWCP considers "likely to cure, give relief, reduce the degree or the period of disability, or aid in lessening the amount of the monthly compensation." See 5 U.S.C. 8103.

In accordance with the discretion granted to DOL and delegated to OWCP, OWCP's Division of Federal Employees' Compensation (DFEC) is instituting a new policy and program to monitor and manage the prescription of opioid medications.

At this time, the new DFEC policy applies only to newly prescribed opioid use (i.e. claims where an opioid has not been prescribed within the past 180 days, if ever). It requires an injured worker's treating physician to complete a Certification/Letter of Medical Necessity, Form CA-27 (LMN), prior to authorization of any opioid medication in claims following an initial 60-day period. All subsequent prescriptions will require that the LMN be received and reviewed by claims staff before medication is authorized and dispensed. Authorizations for opioid drug prescriptions will be limited to a maximum of 60 days, with initial fills and refills to be issued in no more than 30-day supplies. However, the treating physician is encouraged to prescribe the shortest duration of opioid medication that will provide appropriate pain relief. Additionally, not more than two opioids may be authorized at any given time2.

Purpose: To provide guidance to claims staff on the authorization of opioid products (including compounded medications containing an opioid), and the management of cases where a claimant is receiving such a product for a work-related condition other than cancer. For claimants who are newly prescribed opioids (as noted above), OWCP will now require a LMN to continue authorizing opioids for periods following the initial 60 days. Further, such LMN must be updated no less than every 60 days thereafter. In order to avoid a disruption in the provision of medication, injured workers are encouraged to have their physician complete the LMN form 10 to 15 days prior to the end of each 60-day period to allow time for review and approval.

Action: For opioid prescriptions for any work-related condition other than cancer:3

1. Opioid medications in DFEC claims now require prior authorization from OWCP following an initial 60 day period. Upon an initial fill of an opioid prescription, the claimant will be notified at the point of sale that all opioid drugs require a LMN to be completed by his or her physician prior to dispensing, following the initial 60 day period.

2. Opioid medications included as a part of a compounded medication also require prior authorization from OWCP. However, there is no initial 60-day period afforded for such drugs. If the claims examiner (CE) receives a request for a compounded medication containing an opioid, he or she should follow established compounded medication procedures as outlined in FECA Bulletin 17-01.4

3. Subsequent fills of opioid prescriptions occurring after 60 days from the initial fill will require prior authorization. A new LMN will be required every 60 days and each one must be reviewed and approved by the CE. The physician should complete the form 10 to 15 days prior to the end of each 60 day authorization period to allow for a review of the medical documentation in the claim. Once a LMN is authorized, all fills (for a maximum 30 day period and not to exceed two opioid medications at any one time) will be approved until the end of the current authorization period. Any subsequent fill requests received for a period for which there is no LMN and resulting authorization will return an electronic message to the pharmacy notifying both the pharmacist and claimant of the LMN requirement. The fill will concurrently be denied.

4. A properly completed LMN will generate a request for authorization for review by the CE. An incomplete LMN will be returned to the physician for correction. Duplicate LMNs will be returned as will those submitted when there are already two authorized opioid LMNs on record.

5. Upon receipt of an initial authorization request for an opioid medication, the CE should review the medical evidence of record, to include the justification provided on the LMN and supporting medical documentation. In evaluating whether the request should be approved or if further development is necessitated, the CE should assess factors including but not limited to (1) whether the physician has enough knowledge regarding the claimant to arrive at a sound medical opinion, (2) the level of medical rationale provided by the physician, and (3) whether the necessity is based on objective clinical findings versus subjective complaints. See FECA Procedure Manual 2-810.6 for additional discussion on weighing and evaluating medical evidence. If the CE determines that the totality of the medical evidence supports continued opioid use, he or she may approve the initial authorization request without further action. See items 8 and 9 below for necessary actions following receipt of subsequent authorization requests.

6. Should the CE determine additional development is needed, he or she may contact the claimant's physician if additional information is needed. The District Medical Advisor (DMA) may also be consulted to determine the appropriateness of the opioid prescription and pain management plan including the requests for treatment/rehabilitation plans to treat dependence on opioids due to prescriptions for an employment-related condition. The CE may also choose to send the claimant for a second opinion (SECOP) examination if warranted based on the evidence of record. If a Field Nurse (FN) has been assigned to the case, the CE may also direct the FN to address the issue of ongoing opioid usage with the treating physician. The CE may continue to authorize opioid medications while development is pending.

7. The CE may only authorize up to 60 days of additional opioid use with each sufficiently rationalized LMN. Following the expiration of any such authorization, a new LMN is necessary and authorization by the CE will again be required.

8. Continuing opioid use may only be authorized beyond 120 days from the initial fill if the CE has written to the treating physician (or referred the case to a SECOP or DMA) asking for rationalized medical justification for the ongoing prescription of opioid medications. As such, should the CE authorize the second consecutive letter of medical necessity in a given case file, he or she should concurrently write to the treating physician to specifically address the medical necessity of continued opioid medication (or refer the file to a SECOP or DMA). The CE may continue to authorize opioid medications while development is pending as long as there is follow up and/or additional development at reasonable intervals.

9. Cases with continued opioid use should be reviewed by either a DMA or SECOP examination every six months from the first authorization.

10. The requirements in items (8) and (9) may only be waived if exceptional circumstances exist that are certified by a Supervisory Claims Examiner (SCE) or higher authority.

11. If more than six months have passed since the last opioid medication was filled, the process begins anew with an initial 60 days of opioid medication provided without a LMN.

Applicability: Appropriate National and District Office personnel.

Disposition: This bulletin is to be retained until incorporated into the Procedure Manual.

 

ANTONIO RIOS
Director for
Federal Employees' Compensation

Distribution: All DFEC Staff


1 CDC. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 2016

2 In accordance with longstanding FECA policy prohibiting therapeutic duplication, only one such opioid may be a Schedule II drug.

3 The issuance of this bulletin does not supersede or otherwise modify existing guidance on Fentanyl. See FECA Bulletin No. 11–05 (issued May 3, 2011).

4 Unlike other compounded medications, no screening will be performed by the Central Bill Processing Unit (CBP) on compounded medications containing an opioid.

 

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