Future Considerations for Controlled-Release Oxycodone

Oxycodone CR is a slow release opioid narcotic currently indicated for use in moderate and moderate-to-severe pain. When initially released to the market, the indicated use was for pain management in cancer patients and for control of postoperative pain. As the use of controlled-release Oxycodone expanded, problems with addiction and abuse escalated.

In an effort to bring the use of Oxycodone CR under more effective control, H.R. 1366 cited as the “Stop Oxy Abuse Act of 2013” was introduced March 21, 2013 “to direct the Commissioner of Food and Drugs to modify the approval of any drug containing controlled-release (CR) oxycodone hydrochloride, to limit such approval to use for the relief of severe-only instead of moderate-to-severe pain, and for other purposes”. The introduction of the bill followed a petition filed by Physicians for Responsible Opioid Prescribing (PROP) calling for the FDA to modify opioid labeling such that future approval would exclude the term “moderate” from an indicated use for non-cancer pain. As such, approval for use would be limited to severe pain only within this population. However, the bill does not restrict the drug’s use to non-cancer pain but, rather, seeks to limit approval for use to “severe-only pain” for any patient population.

If H.R. 1366 passes, it will operate to remove use of the controlled-release oxycodone drugs for management of any form of moderate pain type diagnoses as an approved indication by the FDA. The prescribing of Oxycodone CR for “moderate” or “moderate-severe” pain would then be considered an “Off Label” use. Within the world of Medicare Set-Aside, provision of controlled-released Oxycodone for such diagnoses would be excluded from the plan of care. Any continued use of Oxycodone CR would require medical documentation and diagnosis of “severe” pain.

Part II – Chronic Pain Conditions Impact on Future Care: Failed Back Syndrome

Patricia Rapson, RN, CCM, CLCP, CBIS, MSCCFailed back syndrome (also known as Failed Back Surgery Syndrome or FBSS) is not considered a diagnosis in itself, but rather a term often used to describe patients who have undergone lumbar surgery and continue to experience chronic and persistent pain syndromes with unsatisfactory outcomes. This condition it is characterized by severe, disabling chronic pain that is generally resistant to physiotherapy, pharmacological treatment and is associated with various degrees of functional disability.  It is estimated that this complication occurs in 5% to 10% of patients after spinal surgeries.

Failed back syndrome has many causes.  If surgery fails to adequately relieve pressure on the nerve or disc herniation recurs, ongoing pain can result.   What if the nerve sustained serious injury?  Full nerve recovery may not be possible, regardless of surgical intervention.  If spinal fusion was performed, incomplete healing of the bone graft and/or hardware failure (i.e. breakage) can lead to persistent instability of the spinal segments requiring additional treatment. The formation of scar tissue at the surgical site also presents challenges which need to be taken into consideration when addressing short-term and long-term future care.

Fibrosis and Adhesions

The formation of scar tissue is a normal part of the healing process.  When we are injured, our bodies launch a complex rescue mission, mobilizing specialized cells to stop the bleeding and lay down a matrix of collagen1.  Other cells (fibroblasts) reorganize these fibers eventually anchoring themselves into the matrix and pulling the wound edges together.  Every wound results in some form of scarring but we all scar differently. In some of us, scars are barely noticeable while in others the fibroblasts are overzealous, laying down excessive amounts of collagen which results in large raised (hypertrophic or keloid) scars.

Internal scar tissue also reflects the body’s natural healing abilities, repairing muscles and tissues injured or cut during a surgical procedure. Internal scar tissue differs from “normal” scar tissue in that it can create tethers, barriers and adhesions to internal body structures, pulling them out of place.

Epidural fibrosis occurs when fibrous tissue replaces the normal epidural fat adjacent to the dura  in the spinal canal. This tissue binds the dura2 and nerve roots to the surrounding structures.  Dense epidural fibrosis can cause nerve root irritation, entrapment, compression and restrict nerve root mobility. When encased in scar tissue, nerve fibers are subject to increased tension, impaired blood supply and a reduced capacity to transport substances along its length. Epidural fibrosis has been reported to be the cause of symptoms in 8-14% of patients with failed back surgery syndrome (FBSS) and is related to a poorer surgical outcome and increased complication rates in patients requiring reoperation.

Chronic Pain Conditions

Multiple treatment strategies have been researched in hopes of finding a way to prevent scar tissue from forming without compromising the wound healing process. A variety of materials have been implanted on top of the dura such as absorbable gelatin sponges and Gore-Tex membranes.  Chemical agents aimed at reducing scar formation suppress fibroblast proliferation after surgery.   Although some methods show promising results, researchers are calling for further studies to determine short- and long-term complications as well as the efficacy of these methods in clinical practice.

Scar tissue (fibrosis) generally forms between 6 weeks and 6 months after surgery, which may be why some individuals experience initial improvement of their symptoms, followed by a gradual return of back and/or leg pain. Undergoing additional surgery to remove scar tissue is not always recommended as the scarring tends to reform and can ultimately leave the patient worse off than they were before.

Some suggest that stretching the nerve root while the body is healing after back surgery can help limit epidural fibrosis from becoming a clinical problem.  The theory is that if the nerve is kept mobile while the wound heals, the nerve will not be bound down by adhesions and the scar tissue that does develop should be less problematic.

Spinal Instability

It is estimated that more than 300,000 spine fusions are performed annually in the United States which reflects a 76% increase in this procedure between 1996 and 2001.  The reasons for spinal instability are numerous and can be related to injury or disease of the bones, discs, joints or ligamentous support structures.

White and Panjabi described spinal stability as the ability of the spine, under physiological loads, to limit patterns of displacement so as to not damage or irritate the spinal cord and nerve roots and, in addition, to prevent incapacitating deformity or pain due to structural changes.  Conversely, instability refers to excessive displacement of the spine that would result in neurological deficit, deformity, or pain.  Instability can have an acute onset, as with spinal fractures or dislocations, or present as chronic conditions (i.e. spondyolisthesis3).

Depending on the circumstances, stabilization can be achieved externally or internally.  Chronic instability (and acute stable injuries such as fractures without displacement and/or nerve compression) can be stabilized with external bracing such as a cervical collar, halo brace or Thoracic lumbo-Sacral Orthosis4 (TLSO).  When applied, external bracing provides support which can improve posture and facilitate unloading of the compressive forces on the spine.  Bracing can also be used as a temporary means of stabilization, before fusion is undertaken or after surgery, until healing occurs.

Back Devices for Chronic Pain Conditions

Spinal fusion is an example of internal stabilization. This can be accomplished with bone grafting, hardware or a combination of both.  Many factors can adversely affect healing after fusion.  According to Pakzaban, these can include malnutrition, cortisteroid use, irradiation, cancer, diabetes, infection, osteoporosis and smoking. Of these, smoking is the most prevalent correctable risk factor.  There is growing evidence that cigarette smoking adversely affects fusion and disrupts the normal function of basic body systems that contribute to bone formation and growth.  In a study of patients undergoing lumbar fusion, the patients who smoked experienced failed fusions in up to 40% of cases, compared to only 8% among non-smokers.

Postoperatively, early mobilization is recommended as it expedites rehabilitation and can prevent complications associated with immobility (deep vein thrombosis, pneumonia etc).  If fusion is performed without instrumentation (hardware) an external support brace or orthosis is utilized until the fusion has matured.  If hardware has been used, an external orthosis may still be applied during healing to provide additional supplemental support for the hardware especially with more extensive procedures.  Although exercise therapy is often delayed several months, some studies suggest that an early home program focused on pain-contingent training for functional strength and endurance of back, abdominal and leg muscles, as well as stretching and cardiovascular fitness is beneficial.

As we all know, surgical fusion of the spine does not always result in relief of pain and FBSS often becomes a chronic condition. Conservative management includes the use of analgesics, anti-inflammatory drugs and physical therapy.  When depression is a factor, psychological intervention may be indicated.  Some physicians also advocate behavioral modification to address smoking cessation, weight loss or other lifestyle changes. Periodic epidural steroid injections or facet injections may be used to provide pain relief and increase functional activities.

Achieving the goal of improved function often involves a patient-centered, multidisciplinary approach.  Treatment planning and future care considerations need to address a biopsychosocial factors as well as spiritual and cultural issues.  With an emphasis on patient education, empowerment, self-management skills and lifestyle changes, the chronic pain sufferer is in a better position to regain control of their life.

In Part III of this series, Chronic Pain Conditions and their Impact on Future Care, we will explore the world of implantable devices used in the treatment of chronic pain conditions.  These include Spinal Cord Stimulators (aka Dorsal Column Stimulators) and Intrathecal Pain Pumps that deliver medication directly to the spinal fluid.

Gould & Lamb Medicare Compliance

1Collagen is any of various tough, fibrous proteins found in bone, cartilage, skin and other connective tissue.  Collagens have great tensile strength, and provide these body structures with the ability to withstand forces that stretch them.

2The dura mater or simply dura is the outermost membrane which envelopes and protects the spinal cord
3Spondylolisthesis is a descriptive term referring to slippage of a vertebra (usually forward) relative to another vertebra.  Spondylolisthesis is graded according to the percent of displacement
4The Thoracic Lumbo-Sacral Orthosis or TLSO brace stabilizes the spine with circumferential pressure. Whereas a Halo brace stabilizes the cervical spine with rigid hardware attached to the skull on one end and fixed to a vest (made of plaster or molded plastic) on the upper body.

References:

1.    Skaf, G., Bouclaous, C., Alaraj, A., Chamoun, R., Clinical Outcome of Surgical Treatment of Failed Back Surgery Syndrome. Surgical Neurology.  64 (2005) 483-489.
2.    Rabb C. Failed back syndrome and epidural fibrosis.  The Spine Journal 10 (2010) 454-455
3.    Ullrich P.  Failed Back Surgery Syndrome (FBSS):  What It Is and How to Avoid Pain after Surgery. Updated 11/4/09.  www.spine-health.com
4.    Ross J, Obuchowski N, Zepp R.  The Postoperative Lumbar Spine:  Evaluation of Epidural Scar over a 1-Year Period.  Am J Neuroradiol 19:183-186, Jan 1998.  
5.    Yildiz K, Gezen F, Is M, Cukur S, Dosoglu M., Mitomycin C, 5-fluorouracil, and cyclosporine prevent epidural fibrosis in an experimental laminectomy model.  Eur Spine J 2007 Sept; 16(9):  1525-1530 (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2200739/pdf/586_2007_Article_344.pdf)
6.    Ulrich P.  Scar Tissue and Pain After Back Surgery.  Updated 3/6/02.  www.spine-health.com
7.    Resnick et al, Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 8:  lumbar fusion for disc herniation and radiculopathy.  J Neurosurg: Spine (2):673-678, Jun 2005
8.    Pakzaban P.  Spinal Instability and Spinal Fusion Surgery Treatment & Management.  eMedicine Medscape Reference. Updated Jun 7, 2010
9.    Deyo RA, Nachemson A, Mirza SK. Spinal-fusion surgery – the case for restraint. N Engl J Med. Feb 12 2004;350(7):722-6.
10.    Brown CW, Orme TJ, Richardson HD.  The rate of pseudarthrosis in patients who are smokers and patients who are nonsmokers:  a comparison study.  Spine 1986; (9):942-3
11.    Holten K, ed.  Managing chronic pain:  What’s the best approach? Family Practice  Dec 2008; 57(12): 806-811.
12.     Panjabi M. Clinical spinal instability and low back pain.  Journal of Electromyography and Kinesiology, 13 (2003) 371-379

Considering Impairment, Disability and Functional Outcome when Projecting Future Care

Patricia Rapson, RN, CCM, CLCP, CBIS, MSCCThe concepts of impairment and disability are often confused and misunderstood.  Depending on the venue in which they are applied, there can be numerous accepted definitions for these terms. Understanding these terms and how they are interpreted by various organizations is vital in determining effective future care costs and projections.

Impairment is from the Latin impejorare, meaning to make worse.  The American Medical Association AMA defines impairment as a “significant deviation, loss, or loss of use of any body structure or body function, in an individual with a health condition, disorder, or disease.” Disability refers to “activity limitations and/or participation restrictions in an individual with a health condition, disorder, or disease.”¹   In other words, disability equates to the limitations and restrictions which result from an impairment.

The World Health Organization – WHO, which serves as the public health arm of the United Nations, considered a somewhat broader view of these terms.  WHO defines impairment as a problem in body function or structure.  Disability, on the other hand, is considered an umbrella term, covering impairments, activity limitations (such as a difficulty encountered by an individual executing a task or action) and participation restrictions (a problem experienced by an individual with involvement in life situations).  WHO recognizes disability as a complex phenomenon, reflecting the interaction between features of a person’s body and features of the society in which he or she lives.  In 2001, the 54th World Health Assembly endorsed WHO’s International Classification of Functioning, Disability and Health – ICF.  This is a classification of health and health-related domains which considers both body functions and structure as well as domains of activity and participation.  The ICF acknowledges that every human being can experience decline in their health and thereby also experience some degree of disability.  Disability is not seen purely as a “medical” or “biological” dysfunction, but a universal human experience in which environmental factors play an important roll in a person’s level of functioning.

In contrast, the Social Security Administration – SSA considers disability as it relates to employment and the inability to engage in any substantial, gainful activity by reason of any medically determinable physical or mental impairment(s).  Such impairments can be expected to result in death or have lasted or can be expected to last for a continuous period of not less than 12 months.  Because under SSA rules a person is either entirely disabled or not disabled at all, a rating system based on percentage of impairment is not utilized.  Instead, the SSA uses a sequence of evaluations and also considers an individual’s age and education in their analysis and ultimate determination.  When an individual is considered disabled under SSA, they may be eligible to receive cash payments as well as coverage under Medicare or Medicaid.

State and private insurance companies also offer a variety of disability plans in which qualification for benefits is not dependent on an on-the-job injury, however there may be provisions which require an initial period of disability prior to receiving benefits.  Many of these policies tend to be broader than those offered by Workers’ Compensation.

There are many definitions of disability under Workers’ Compensation, although, they typically include statements which refer to a reduction in ones wage-earning capacity as a result of an injury, illness, or occupational disease that arose out of, or in the course of employment.  In Workers’ Compensation, disability can be considered permanent or temporary, as well as partial or total.  Permanent impairments are those which have reached a state of Maximum Medical Improvement – MMI or are Permanent & Stationary – P&S.  At this point the impairment is considered static / stable, has had sufficient time to allow optimal tissue repair and is unlikely to change, despite further medical or surgical intervention.

The purpose for impairment rating is to represent the impairment by using a generally accepted system to estimate the degree to which illness or injury diminishes an individual’s capacity for daily activities. Impairment ratings are commonly used in a legal setting where they can help the parties understand the extent of an injured workers limitation and are also considered when determining compensability and settlement.

Impairment rating systems vary considerably depending on the state and/or jurisdiction involved.  While some states have specific statuary requirements regarding methods of permanent impairment rating – PIR, other states have abandoned the available guidelines in favor of developing their own rating standards.

The Impact of Individualized Future Care on Disability

Projecting Future CareImpairments, although they may be significant, do not necessarily equate into total and permanent disability.  Access to appropriate care and services after catastrophic illness or injury is imperative to achieving the highest functional outcome possible.  Accurate and comprehensive evaluation and interpretation of the medical records is a necessary step when considering the future care needs of claimants.  The impact of appropriate adaptive devices and/or services such as physical and occupational therapy can help to maximize function and can make the difference between dependence and independence in the ability to successfully perform activities of daily living.

Activities of daily living – ADL can be broken down into two groups or categories; basic and advanced (instrumental).  Basic ADLs represent those activities that are necessary for self care.  These include activities such as bathing, dressing, grooming, toileting, feeding oneself and mobility (standing, walking, transferring, etc.).  In other words, all those activities you independently performed prior to leaving the house for school when you were young.  Advanced (Instrumental) ADLs, although not vital for fundamental functioning, allow an individual to live independently in a community.  Advanced ADLs encompass activities such as shopping, planning and preparing adequate meals, housekeeping, laundry, using the telephone, accessing transportation, appropriately taking medications, and the ability to handle personal finances.

Consider a 24 year old man who has sustained a catastrophic injury, a complete spinal cord injury (permanent impairment) resulting in paraplegia.   After his acute recovery, he goes to in-patient rehabilitation where he receives intensive therapies and instruction.  It is not uncommon for an individual such as this to ultimately live independently; drive a vehicle adapted with hand controls, and work full time.   Mobility independence using a wheel chair is still considered independent mobility, albeit modified.  And with the appropriate equipment and training, the gentleman in this scenario remains modified independent with his ADLs.

When planning for future care, whether for a Life Care Plan, Medical Cost Projection or a Medicare Set Aside, it is important to understand and consider how the impairment and resulting disability impact the individual.  In addition, just as our needs change as we age, so do the needs of those with impairment and disability.  These are issues that must also be considered so that the items and services in the plan appropriately coincide with changing needs.   Effective future care planning involves the ability to understand and interpret the available information, physician recommendations and standards of care as well as the  knowledge, expertise and experience of the individuals who develop them.

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¹Rondinelli R, Changes for the New AMA Guides to Impairment Ratings, 6th Edition:  Implications and Applications for Physician Disability Evaluations. PM&R, July 2009, Vol 1 (7); 643-656  http://www.ncbi.nlm.nih.gov/pubmed/19627958

According to CMS – Rated Age Does Matter

“Age doesn’t matter, unless your cheese”….. Or does it?

Patricia Rapson, RN, CCM, CLCP, CBIS, MSCCThe American actress, “Billie” Burke (AKA Glenda the Good Witch from The Wizard of Oz) left us with that humorous quote.  Depending on one’s point of view, people tend to either embrace their age or become uncomfortable when discussing it.

Age becomes an important factor to consider when determining future medical care and has a direct impact on cost.  The math is simple; the longer someone lives, the greater the quantity and cost of healthcare required.  In a 2006 report, the Agency for Healthcare Research and Quality (AHRQ) referenced a study which outlined the distribution of expenses over the major phases of an average person’s lifetime.  Nearly half (49%) of the health care costs were consumed by individuals 65 and older.

Life Expectancy: Actual Age vs. Rated Age

Rated Age Does matter

Life expectancy is a measure often used to gauge the overall health of a population and represents the average number of years of life remaining that could be expected if current death rates were to remain constant.  Our actual age refers to our chronological age and is based on the year we were born. A rated age (also referred to as a medical age) is one’s age adjusted to take into consideration the impact of pertinent medical conditions and impairments.  Underwriters, actuaries and structured settlement brokers apply information from published medical studies, peer reviewed journals and literature to determine the effect that specific medical conditions have on overall life expectancy.  Physicians are also considered qualified to address life expectancy.  Rated age calculations are based on conditions, either associated with the illness or injury at issue; or, existing co-morbidly (conditions such as cancer or diabetes which exist simultaneously but are separate).  Typically, a rated, or adjusted age, reflects a remaining life expectancy which is shorter than chronological age would predict.  Thus, applying a rated age to the anticipated future medical care in a Medicare Set-Aside Arrangement usually results in a reduction of life time costs.

The Centers for Disease Control and Prevention (CDC) publishes the National Vital Statistics Report which  includes period life tables for the United States categorized by age, race, and sex.  Life expectancies listed in the current tables are based on the age-specific death rates as they were in 2006.  Periodically, as additional data is available, these tables are updated.  The good news is, overall we are living longer.  The most recent recalculation of the life tables reflected an overall 0.3 year increase in life expectancy.

CMS Requires Submitters to Include Specific Rated Age Language

In their 7/23/01 memo, the Centers for Medicare and Medicaid Services (CMS ) noted  that a Worker’s Compensation Medicare Set-Aside  (WCMSA) should be funded based on the life expectancy of the claimant unless State law specifically limits the length of time that Worker’s Compensation covers work related conditions.  Since then, CMS has provided further clarification to submitters  regarding rated ages and their use when associated with WCMSA’s.

CMS will only accept life expectancy calculations taken from the CDC Table 1, which includes life expectancy estimations of the total US population. In addition, submitters must now include specific rated age language in the form of a certification statement.  All independent rated ages are included with submission as acceptable proof of their authenticity.  CMS has indicated that failure to include these items results in their rejection of the rated age and the recalculation the WCMSA amount based on the claimant’s actual age.

Life Care Plans differ greatly from Medicare Set Asides.  While both reports address future care, the MSA reflects costs which would otherwise be covered by Medicare.  Life care plans are need driven documents and consider all contingencies related to one’s anticipated lifetime care and treatment.  In these reports, life expectancy is based on actual age and utilizes the life table most appropriate to the individual’s demographic.  The experts who develop life care plans are rarely experts in determining life expectancy.  Therefore, when (and if) indicated, rated ages should be provided by qualified experts.  The information can then be appropriately incorporated into the life care plan.

No matter what our age, there are positive and negative factors which will influence life expectancy.  Cheese or no cheese, when age does matter you can be confident that the experts at Gould & Lamb will identify all the pertinent information necessary to ensure you

Workers’ Compensation Settlement with Medicare Set Aside Allocations

On August 18, 2010, Missouri Lawyers Media published an article explaining how, in a Missouri  Workers’ Compensation Medicare Set Aside, WCMSA case, the inherent uncertainty of the Workers’ Compensation Review Center’s procedure and unfamiliarity with the Medicare Secondary Payer Act (MSP) can combine to create costly consequences.

WCMSA Allocation Subjects Carrier to Motion to Enforce Settlement

Briefly, the parties to a workers’ compensation case agreed to settle the matter for $85,000.00 for the indemnity benefits and had projected what appears to be approximately $240,000.00 as a Medicare set-aside amount. The settlement paperwork submitted to the court apparently included language that the final settlement amount was to be determined and paid upon receipt of the MSA determination from CMS with no explanation as to what would occur should the CMS determination fail to match the defense’s future medical projection. Predictably, CMS determined that the parties’ MSA was $189,000.00 too low to protect Medicare’s interests. The carrier had resisted payment of the increased amount, according to the article, until a petition to enforce the settlement was filed.

The reported case illustrates critical points when attempting to settle a workers compensation case that involves a Medicare beneficiary or an injured worker with a “reasonable expectation” of Medicare eligibility within thirty (30) months of settlement.

Without an express statement of the amount that CMS determines appropriate to protect Medicare’s interests, no certainty can be had. Settlement paperwork that establishes a settlement amount contingent upon a CMS allocation leaves the parties with no choice but to accept the CMS amount. CMS submission must be done well before a settlement of future medical benefits is negotiated. A set aside allocation, no matter how reasonable, that has not been previously reviewed and approved by CMS before settlement, is subject to increase or modification based upon a number of factors.

While many would argue that those factors are, at times, arbitrary and inconsistent, there is virtually no reason why the parties to the case reported above ended up in such a sad situation. The Missouri example appears to show us that, despite the well entrenched workers’ compensation practice encouraging MSA submission, the litigants unprepared to deal with the CMS review process can expect problems in their cases.

Settlement Negotiation and Pre-Approved CMS Future Medical Cost Projection Can Alleviate Enforcement Woes

Gould and Lamb recommends several steps that may avoid the situation described in the Missouri example. Settlement negotiation should be preceded by a realistic projection of future medical costs. CMS submission of a WCMSA can be made at any time in the litigation process. If the parties properly recognize that their case may impact Medicare’s rights as a secondary payer, Medicare should be dealt with early in the settlement process rather than as an afterthought. If the parties disagree with a CMS determination, settlement language must be crafted to determine which party will be responsible for an overage (if any) and how the difference in the amounts will be handled.

Additionally, submitting settlement paperwork to a judge or hearing officer for approval prior to receiving a CMS determination of an appropriate amount or before receipt of a reasonable, defensible cost projection sets the stage for serious problems. Remember also that CMS submission is not required, even in workers’ compensation cases.  In the Missouri debacle, the parties might well have agreed to settle based upon the projection provided. While their settlement may have been subject to later action by Medicare based upon the exhaustion of funds, the argument still could be presented that Medicare’s interest were taken into account and that the parties acted in good faith.

For litigants and practitioners, ignorance or inattention to the options available when dealing with CMS and Medicare compliance will result in workers’ compensation cases like the one described above. Likewise, failure to craft appropriate Workers’ Compensation settlement language may seriously impact your case.

Gould and Lamb’s Willins Risk Analysis Program is a web based tool that assists our clients in determining Medicare exposure along with course of action recommendations as the case proceeds toward settlement.

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