STRYKER ABG II & REJUVENATE - PowerPoint Presentation

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STRYKER ABG II & REJUVENATEROUND 2

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MSA EXECUTION DATE: December 19, 2016Qualifying Revision Surgery (“QRS”) must be before this date to qualify for Round 2.ENROLLMENT OPEN: January 17, 2017ENROLLMENT DEADLINE: March 1, 2017Participating claimants must enroll by March 1st

, 2017. ENHANCEMENT BENEFIT OPEN: June 13, 2017Enhancement Benefit Program (“EBP”) award applications will begin on this date.ENHANCEMENT BENEFIT CLOSE: August 14, 2017Enhancement Benefit Applications must be submitted before this date (excludes Future Matrix Awards, which must be submitted within 90 days of date of accrual, subject to same timing limitations as Round 1).WALK AWAY DEADLINE: May 1, 2017Stryker must exercise walk-away rights on this date (or 60 days from the date of the Enrollment deadline if that deadline is extended).

ROUND 2: KEY DATES

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U.S. Citizen or Legal Resident (Section 2.1.1)Implanted with Rejuvenate Modular System or ABG II Modular System (“Affected Product”) in the United States, U.S. Territory, or U.S. Military Hospital (wherever located)Claimant underwent Qualified Revision Surgery (“QRS”), orClaimant requires Revision Surgery but is too infirm to undergo the procedure

ELIGIBILITY

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QUALIFYING REVISIONBase Award: $300,000ENHANCEMENT BENEFITS*Re-Revision: $175,000Controlled Osteotomy: $75,000Abductor Repair/Reattachment: $75,000Intra-Operative Femur Fracture: $40,000Additional Surgery – Femur Fracture: $100,000

Additional Surgery – Abductor Repair: $100,000Additional Surgery – Remove Psuedotumor: $70,000 Not Listed: Awards for Dislocation, Infection, Foot Drop, PE/DVT, Heart Attack, Stroke, or Death*SUMMARY ONLY – Details regarding amounts and restrictions below

AWARD AMOUNTS

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Definition of “Qualified Revision Surgery” (“QRS”) is identical to Round 1.QUALIFICATIONS

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WHAT IS “RELATED TO THE VOLUNTARY RECALL”?From STRYKER URGENT PRODUCT CORRECTION to SURGEONS May 01,2012: Hazards1. Excessive metal debris and/or ion generation. Fretting and/or corrosion at or about the modular neck junction may lead to increased metal ion generation in the surrounding joint space.a. Contact between metal ions and tissues and structures during an implant's service life may result in an Adverse Local Tissue Reaction (ALTR), the inflammation of associated tissues experiencing immunological response (

metallosis, necrosis, and/or pain). An ALTR may result in the need for revision surgery. b. Patients with a heightened sensitivity to these ions may experience a hypersensitivity/allergic reaction which may result in the need for revision surgery.2. Excessive fretting debris. Fretting may lead to increased metal debris in the joint space (concentration of debris exceeds individual patient threshold) resulting in osteolysis. Osteolysis may be asymptomatic and may result in the need for revision surgery.

QUALIFICATIONS

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You must still demonstrate at least one of the following:You also must submit annotated medical records as proof:QUALIFICATIONS

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EXAMPLES OF QUALIFICATIONS IN ANNOTATED RECORDS:Elevated Cobalt:Abnormal Diagnostic Scan:Intraoperative Confirmation of ALTR:

QUALIFICATIONS

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Excluded Revision Surgery (Section 1.2.37) Surgery was necessitated solely by Infection (as defined); (Section 1.2.37.1)

Surgery was necessitated by Trauma and revision not otherwise needed (as defined); (Section 1.2.37.2)Surgery was necessitated solely by Dislocation, Disassociation or Subluxation (as defined); (Section 1.2.37.3)

Surgery was necessitated by an

Implant Fracture

;

(Section 1.2.37.4)

Surgery involved removal of an

Off Label Neck and Stem Size Combination

(as defined)

(Section 1.2.37.5)

EXCLUSIONS

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EXCEPTIONS:Infection or Dislocation will qualify if contemporaneous records demonstrate:Elevated Cobalt Level, orAbnormal Diagnostic Scan associated with the tissue around the femoral implant related to the reasons underlying the Voluntary Recall, orIntra-operative or Pathologic confirmation of ALTR, ALVAL, or Tissue Damage related to the reasons underlying the Voluntary RecallTrauma

may qualify if contemporaneous records demonstrate:“more likely than not, the claimant would have required revision in the near term regardless of the Trauma” (Section 1.2.37.2)EXCLUSIONS

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AMOUNTS: (Section 7.1)Claimants with an Attorney (Represented)$300,000* for each revised hip – subject to cumulative reductions set forth below.

$1,500 * – for a current spouse.Claimants without an Attorney (Unrepresented)$213,000* – subject to cumulative reductions set forth below. $1,065* – for a current spouse.

* Subject to a deduction for administrative costs and common benefit fees and/or expenses.

BASE AWARD - REVISION

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BASE AWARD REDUCTIONS:Unrelated Death Prior to Enrollment (Section 7.1.5.2) Thus, do not delay in enrolling because if client predeceases enrollment, award goes down substantially.

30% Reduction of Base.Age (at time of Implantation of the Affected Products). (Section 7.1.5.3)≥ 70: 5% Reduction of Base≥ 75: 10% Reduction of Base≥ 80: 15% Reduction of Base≥ 85: 20% Reduction of Base

Affected Product Implanted as a Revision Device

(Section 7.1.5.4)

But

not

if it was the first femoral stem (so the reduction is NOT applicable for revision of a resurfacing)

15% Reduction of Base.

No Reductions to a Base Award relating to Obesity or Smoking.

*

*

Reductions for obesity and smoking will apply only to certain Enhancements.

BASE AWARD - REVISION

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AMOUNT:Claimants with an Attorney (Represented)$75,000* not subject to reductions or enhancements (Section 8.1.2)Not entitled to any additional awards – even if subsequently revised.

Claimants without an Attorney (Unrepresented)$53,250* – not subject to reductions or enhancements. Not entitled to any additional awards – even if subsequently revised. *

Subject to a deduction for administrative costs and common benefit fees and/or expenses.

BASE AWARD - INFIRM

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An Enhancement Award Schedule sets forth the benefits available under the following Past Matrix Levels*:Matrix Level I (Re-Revision Surgery / Osteotomy / Femur Fracture / Abductor Muscle Repair)Matrix Level II (Major Complications)Additional Surgery

DislocationInfectionFoot Drop PE/DVT Matrix Level III (Myocardial Infarction)Matrix Level IV (Stroke)Matrix Level V (Death)Matrix Level VI (Lost Wages)* Past Matrix complications are those occurring prior to Enrollment

ENHANCEMENTS

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Enhancement Benefit Cap (Section 7.2.2)$450,000 for each hip that underwent a Qualified Revision Surgery$550,000 for each hip that underwent a QRS where the Claimant qualifies for an Enhancement for InfectionThere will be no Enhancement Benefit Cap for MI, Stroke, Death or Lost wages unless the underlying covered events occurred after the Enrollment Date, in which case the $450,000 Cap applies.

ENHANCEMENTS

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Matrix Level I:Matrix I(a): Re-Revision: $175,000 for the first Re-Revision; $100,000 for each subsequent (maximum 3 per hip)Matrix I(b): Events Associated with QRS or Covered Re-Revision:$75,000 per Controlled Osteotomy

(maximum 2 per hip)$100,000 per Intraoperative Femur Fracture with Osteotomy (maximum 2 per hip)$40,000 per Intraoperative Femur Fracture without Osteotomy (maximum 2 per hip)$75,000 per Surgical Repair of a Damaged Abductor Muscle Complex (maximum 2 per hip)

ENHANCEMENTS

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Matrix Level II(a): Additional Surgery:$35,000 per Additional Surgery to Remove Hardware implanted during an osteotomy or repair of an intraoperative femur fracture (maximum 2 per hip)$70,000 per Additional Debridement Surgery or Surgery to Remove a Pseudotumor (maximum 2 per hip).$100,000 per

Additional Surgery to Reattach or Repair a Damaged Abductor Muscle Complex (maximum 2 per hip).$50,000 per Additional Surgery to Place a Constrained Component due to Dislocation (maximum 2 per hip).$100,000** per Additional Surgery to Repair a Post Revision Femur Fracture within 90 Days of a Qualified Revision Surgery or Re-Revision Surgery (maximum 2 per hip).**(10% reduction for BMI >

40; 15% reduction for BMI

>

50 at Revision)

*

Claimant shall only receive 1 Additional Surgery Enhancement (the greatest of which applies) per Matrix Level II.

ENHANCEMENTS

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Matrix Level II(b): Dislocation$25,000 per dislocation managed in a closed reduction. $60,000 per dislocation managed in an open reduction. $75,000 per dislocation managed in an open reduction with conversion to a constrained component due to dislocation.(10% reduction for BMI > 40; 15% reduction for BMI >

50 at Revision)First dislocation must occur within 9 months of QRS or Covered Re-RevisionMaximum of 3 dislocation awards per hip in which Affected Product was removed.ENHANCEMENTS

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Matrix Level II(c): Infection$30,000 per infection managed in a debridement or irrigation surgery under general anesthesia.$75,000 per two staged surgery under general anesthesia requiring removal of head, shell and/or liner. $10,000 per infection managed with IV antibiotic treatment lasting 6 weeks or longer. $15,000 per 16 days of confinement in a skilled nursing facility (up to 60 days)Infection in the hip from which the Affected Product was removed must be diagnosed within 9 months of the Qualified APRS, Covered Re-Revision or Additional Surgery. Treatment must begin within 90 days of diagnosis.

Maximum number of Infection surgical enhancements shall be 1 per surgery and 2 in total. An individual who qualifies for an Infection Enhancement under Matrix Level I and II will only receive 1 – the greater of which applies. ENHANCEMENTS

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Matrix Level II(d): Foot Drop$20,000 per Foot Drop that is documented as existing for more than 90 days following a Qualified APRS or Re-Revision Surgery. Compensation based upon Age and Severity for a Foot Drop that is documented as existing 365 days after a Qualified APRS or Re-Revision Surgery.*

Moderate means that the Claimant experiences a gait alteration requiring crutches, can or a walker for a substantial portion of activities of daily living as a result of the Foot Drop.Severe means that the Claimant requires a wheelchair for a substantial portion of activities of daily living or underwent an amputation as a result of the Foot Drop.

ENHANCEMENTS

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Matrix Level II(e): PE/DVT$20,000 for a DVT.$35,000 for a PE. Diagnosis had to be made during the hospitalization for the QRS or Covered Open Surgical Procedure or within 72 hours of the QRS or Covered Open Surgical Procedure itself.Claimant is entitled to just 1 PE or DVT Enhancement per QRS or Covered Open Surgical Procedure.

Maximum number of PE/DVT Enhancements shall be 2 – regardless of the number of Covered Surgeries.ENHANCEMENTS

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Matrix Level III: Myocardial InfarctionEnhancement is based upon based upon (a) the pre- and post-myocardial infarction change in Functional Classification (as defined by the New York Heart Association), and (b) the Claimant’s age on the date of the MI as follows:

*Must occur during the hospitalization for the Qualified APRS or Covered Open Surgical Procedure or within 72 hours of the Qualified APRS or Covered Open Surgical Procedure itself.*10% reduction for BMI > 40; 15% reduction for BMI > 50 at Index*5% reduction for current smoker at time of Revision.

*Maximum number of MI Enhancements shall be 1

ENHANCEMENTS

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Matrix Level IV: StrokeEnhancement is based upon based upon (a) the American Heart Association Stroke Outcome Classification, and (b) the Claimant’s age on the date of the Stroke as follows:

*Must occur during the hospitalization for the QRS or Covered Open Surgical Procedure or within 72 hours of the QRS or Covered Open Surgical Procedure *10% reduction for BMI > 40; 15% reduction for BMI > 50 at Index

*5% reduction for current smoker at time of Revision

*Maximum number of Stroke Enhancements is 1

ENHANCEMENTS

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Matrix Level V: Death$100,000 per minor child. $25,000 per adult child.$50,000 per parent.Lost income – as applicable under state law – through Age 62.*Must occur during hospitalization for QRS or Covered Open Surgical Procedure

* Cannot be combined with any other Enhancement for the same QRS or Covered Surgical Procedure* 10% reduction for BMI > 40; 15% reduction for BMI > 50 at Index* 5% reduction for current smoker at time of Revision. * Minimum Recoverable is $100,000. Maximum Recoverable is $600,000.ENHANCEMENTS

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Matrix Level VI: Lost WagesClaimants are eligible to receive up to $200,000 for wages lost as a result of a QRS or Re-Revision Surgery.** Threshold for eligibility is 20% of the Claimants’ aggregate income for the 2 years preceding his/her Index Surgery.* Any amounts recoverable will be set off by amounts received for lost wages under the

Broadspire Program. ENHANCEMENTS

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FUTURE MATRIXA Future matrix is available to compensate Claimants who suffer Past Matrix Level complications after the Enrollment Date and within 2 years of the Qualified APRS or the last pre-enrollment Covered Open Surgical Procedure. While there will be no reduction in benefits for Covered events that occur within one year of the Enrollment Date, events that occur during the 2nd year following the Enrollment Date will be subject to a 30% reduction.

ENHANCEMENTS

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MANY OF THE RELEVANT TERMS AND CONDITIONS ARE THE SAME IN ROUND 2.THE KEY DIFFERENCES ARE OUTLINED IN THE FOLLOWING SLIDES.DIFFERENCES: ROUND 1 vs. ROUND 2

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THIS IS THE BIGGEST CHANGEIf you plan on applying for awards for Osteotomies, Intra-Operative Femur Fractures, or Surgical Repair of Abductor Damage, which are treated during the QRS, you need to be aware of this…“QRS-RELATED ENHANCEMENTS”

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Claimants will need to apply for any Enhancements which are related to the Qualified Revision Surgery (“QRS”) at the same time that the application for the Base Award is submitted. (1.2.64)If you have claims for any of the following which happen during the Qualified Revision Surgery (Matrix I(b)):OsteotomyIntra-Operative Femur FractureSurgical Repair of Damaged Abductor Complex

YOU MUST APPLY FOR THEM AT THE SAME TIME AS THE BASE AWARD – BY MARCH 1, 2017.“QRS-RELATED ENHANCEMENTS”

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The purpose of this change is to expedite lien resolution.By combining the lien resolution process for the Base Award and the QRS-Related Enhancements, lien resolution for these claims can be done all at one time.This will allow these awards to be paid out at the same time as the Base Award.This does not apply to Re-Revision surgeries – any Enhancement claims which occur during a Re-Revision (or other Enhancements occurring after the QRS) will still be applied for during normal Enhancement Benefit Claim application period.

“QRS-RELATED ENHANCEMENTS”

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PROS:SIMPLER LIEN RESOLUTION PROCESSFEWER AWARDS TO MANAGEFASTER PAYMENTLOWER LIEN RESOLUTION FEESENROLLMENT FORMS MODIFIED TO REFLECT THIS CHANGECONS:YOU HAVE TO APPLY FOR THEM DURING THE ENROLLMENT TIMEFRAMEIF YOU APPEAL A DENIAL OF A QRS-RELATED ENHANCEMENT CLAIM, THE BASE AWARD WILL BE HELD PENDING THE OUTCOME OF THE APPEAL

(9.2.2.2.1)- BASE AWARD LIEN RESOLUTION CANNOT BE COMPLETED UNTIL THE BASE + QRS-RELATED AWARD AMOUNT IS KNOWN, SO THE BASE AWARD WILL NOT BE PAID OUT UNTIL THE APPEALED CLAIM IS RESOLVED“QRS-RELATED ENHANCEMENTS”

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“QRS-RELATED ENHANCEMENTS”

The Enrollment Claim form for Round 2 includes specific questions to remind you of the application requirements.

To apply for these enhancements:

“Are you applying for QRS-Related Enhancements?”

ANSWER: YES

Select the QRS-Related Enhancements which are demonstrated in the medical records from the QRS Surgery.

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Claims Administration Procedures (or “CAPs”) to clarify enhancement eligibility requirements have been incorporated into Round 2:CAP 2: Abductor Repair: CLAIMS ADMINISTRATION PROCEDURES

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CAP 3: Proximal Body Revision: CAP 4: Intra-Operative Femur Fracture:CLAIMS ADMINISTRATION PROCEDURES

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“FEMORAL WINDOW” and “UNICORTICAL” OSTEOTOMY awards qualify for compensation under Round 2.Award Amount is $75,000.00 – just like Extended Trochanteric Osteotomy Claim.If these happen during the QRS, remember to apply for them as a QRS Related Enhancement.OSTEOTOMY AWARDS

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FEMORAL WINDOWUNICORTICAL OSTEOTOMY

OSTEOTOMY AWARDS

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Loser pays for the cost of the appeal (10.1.4)Frivolous Appeals: The Special Master may assess costs of up to $10,000.00 upon finding of no legitimate grounds for appeal (5.4.1.4)HOC or SOC may also petition Claims Administrator to assess costs to the Principal Responsible Attorney based upon trends of appeals (so this applies to Stryker too) (5.4.1.4.1)

An appeal of a QRS-Related Enhancement will hold up the issuance of the Base Award pending the outcome of the appeal (9.2.2.2.1).APPEALS

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Records submitted in support of a claim must be contemporaneous to the treatment for the underlying injury (6.2 and 7.2.1.1)This was also a requirement of Round 1, but Round 2 clarifies that records which are not contemporaneous will not be counted or considered as part of the claim package.Wage claims are the only exception to this rule.CONTEMPORANEOUS RECORDS

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Lien Administrator shall complete their duties within 6 months of receipt of Award Determination from Claims Processor (extension may be granted for good cause shown) (9.1.6.2 and 9.2.4.2).Base Award (including QRS-Related Enhancements) and EBP Award Determinations will be considered separately.LIEN RESOLUTION TIMING

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STRYKER ROUND II LIEN RESOLUTION

PROVIDIO: EXCLUSIVE LIEN RESOLUTION & QSF ADMINISTRATOR

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Stryker II Lien Resolution

Medicare

and

Medicaid

to be handled in same manner as First Round.

Medicare model: revisions pay $19,130. Lesser amounts due depending on Medicare date of eligibility versus revision date and/or whether claimant had any other health plan coverage

Private Lien Resolution Programs

: 5-6 different

PLRPs

to resolve Private and Medicare Part C liens with pre negotiated discounts or reimbursement figures.

Providio

will communicate a process for collecting

lien correspondence

and any

necessary forms

for

PLRP

participation.

Providio

will be hosting a comprehensive

Liens Webinar

tentatively scheduled for Feb 1

st

or 2nd

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Be careful with the following issues which became apparent during Round 1:Abductor Damage/Repair Claims: Complete destruction of abductor muscles (either incapable of repair or without evidence of repair) has been denied for compensation under Round 1. Do not assume that claimant will get an award for abductor damage/repair on extreme abductor damage alone. ALSO: be careful with “standard closure” of the surgical wound vs. “repair” of the abductors. Mere mention of abductors during closure of surgical wound is not sufficient for “repair”. Proximal Stem Revisions: Revision of the proximal portion of a modular stem (i.e. Restoration) is NOT compensable as a Revision or a Re-Revision.

LESSONS LEARNED

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Infection Suspected or Diagnosed at Time of Revision: an infection, whether suspected or confirmed at the time of the QRS, does not qualify for a post-operative infection Enhancement. Two Stage Infection Related Revision: Despite the fact it’s two surgical procedures you only get compensated ONCE.Dislocations That Precede Revision: DO NOT QUALIFY

Wage Loss that Precedes Revision: DOES NOT QUALIFYFractures That Are Not Repaired: Enhancement is only for those intraoperative femur fractures that ARE REPAIRED. Subsequent Surgery to Repair a Non-Healing Osteotomy or Femur Fracture: Not compensable as another post op femur fracture. May be a removal of hardware. Time Limitations:Dislocation: Within 9 months QRS or

QRERS

only!

Infection: Diagnosed within 9 months

Post Op Femur Fracture: 90 Days of

QRS

or

QRERS

only!

Appeals

: Special Masters will review paper only – there is no right to appear before them. Make sure that you clearly state your case in your appeal form, and do your best to resolve the issue with Garden City Group before allowing case to go to Special Master.

LESSONS LEARNED

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THANK YOU