Indiana Worker's Compensation Institute

Introduction
The Dynesys® Spinal System is an investigational device currently limited by US (Federal) law to investigational use in the US. The US Clinical Study of the Dynesys System is a multi-center prospective, randomized, controlled clinical trial comparing the safety and effectiveness of the Dynesys Spinal System to spinal fusion surgery.

The Dynesys system uses flexible materials to stabilize the affected lumbar region while preserving the natural anatomy of the spine. The system is designed to stabilize the spine without fusing.

Study objectives
The objective of this clinical investigation is to compare the safety and effectiveness of the Dynesys Spinal System to spinal fusion surgery in the treatment of lower back and leg pain that results from spinal stenosis and/or spondylolisthesis at one or two adjacent vertebral levels between L1 and S1.

Study overview
Approximately twenty centers will be enrolling patients into this study to assess the safety and effectiveness of the Dynesys Spinal System. This new treatment will be compared to the current standard treatment to see which is more successful.

This is a randomized trial where 67% of the patients will receive the Dynesys Spinal System and 33% will receive posterior lumbar fusion, a standard procedure utilizing a pedicle screw and autograft. Patients will be randomly assigned to receive either the Dynesys Spinal System or spinal fusion surgery.

Patients will be required to return to the clinic for periodic checkups for a minimum of 2 years.

Study sponsors

·         Centerpulse Spine-Tech Inc. (d/b/a Zimmer Spine, Inc.)

Headquartered in Minneapolis, MN, Zimmer Spine researches, develops, and manufactures spinal implants and instrumentation. For more information about Zimmer Spine, visit www.zimmerspine.com.

Status
Recruiting

Participating sites and contact information
Please contact a hospital near you for additional information on participating in this clinical study.

California
Colorado
Georgia
Indiana
Louisiana
Maryland
Michigan
Minnesota
New York
North Carolina
Pennsylvania
South Carolina
Texas
More centers that are participating in this clinical trial will be added to this list shortly.

California:
Center:
The Spine Institute at St. John’s Health Center
Primary investigator:
Rick Delamarter, MD
Address:
1301 20th Street, Suite 400
Santa Monica, CA 90404

Coordinator contact:
Parveen Sra, M.P.H.

Phone:
310-828-7757

Fax:
310-828-6847

Website:
www.espineinstitute.com

Center:
Pacific Regional Neurosurgery Interventional Pain Medical Center
Primary investigator:
David B. Bybee, MD

Address:
1524 McHenry Ave. Suite 135
Modesto, CA 95350

Coordinator contact:
Diane Mellor

Phone:
209-571-0288

Fax:
209-571-0326

Email:
dianem@prnpain.com

Colorado:
Center:
Denver Spine Clinic

Primary investigator:
David Wong, MD

Address:
1601 E. 19th Avenue, Suite 4000
Denver, Colorado 80218

Coordinator contact:
Betsy Annesser

Phone:
303-563-3202

Fax:
303-839-7188

Website:
www.denvermicrospine.com

Georgia:
Center:
Northside Hospital

Primary investigator:
D. Hal Silcox, III, MD

Address:
5505 Peachtree Dunwoody Rd., Suite 600
Atlanta GA, 30342

Coordinator contact:
Anita Sharitt, MSHSA, RN, ONC

Phone:
404-425-1015

Fax:
404-943-0641

Website:
www.POCAtlantia.com

Indiana:
Center:
Fort Wayne Orthopedics

Primary investigator:
Kevin Rahn, MD

Address:
7601 W. Jefferson Blvd
Fort Wayne, IN 46804

Coordinator contact:
Kelly Francher, CCRC

Phone:
260-436-8686

Email:
research@fwortho.com

Louisiana:
Name of center:
Louisiana Orthopedic

Primary investigator:
Jorge E. Isaza, MD

Location:
16777 Medical Center Drive
Baton Rouge, LA 70816
Contact name:
Maria Reyes

Phone number:
225-751-6666

Fax number:
225-751-6680

Website:
www.louisianaortho.com

Maryland:
Name of center:
Greater Baltimore Medical Center
Primary investigator:
Reginald Davis, MD

Location:
6569 N. Charles Street, Suite 403
Baltimore, MD 21204
Contact name:
Jackie Murphy, RN

Phone number:
410-828-4621

Fax number:
410-321-9773

Name of center:
Scoliosis and Spine Center

Primary investigator:
Paul C. McAfee, MD

Location:
1505 Osler Drive, Suite 104
Towson, MD 21204

Contact name:
Erin Shicosky, RN

Phone number:
410-337-8888

Fax number:
410-822-4833

Michigan
Name of center:
Michigan Brain & Spine Institute

Primary investigator:
Douglas F. Geiger, MD

Location:
5315 Elliot Dr., Suite 102
Ypsilanti, Michigan 48197
Contact name:
Dori Danbury, PA

Phone number:
734-434-4110

Fax number:
734-434-1966

Email:
dgeiger@MiBSi.com

Website:
www.MiBSi.com

Minnesota:
Primary investigator:
John Sherman, MD

Location:
6600 France Ave. S., Suite 605
Edina, MN 55435
Contact name:
Barb deBorhegyi, RN

Phone number:
952-920-4333 x325

New York:
Name of center:
Upstate Medical University
Primary investigator:
Hansen A. Yuan, MD

Location:
550 Harrison Center, Suite 130
Syracuse, NY 13202
Contact name:
Susan Hemingway

Phone number:
315-464-8608

North Carolina:
Name of center:
Triangle Orthopaedic Associates, P.A.
Primary investigator:
Tom Dimmig, MD

Location:
120 William Penn Plaza
Durham, NC 27704
Contact name:
Carol Barmann, MS, CCRP

Phone number:
919-281-1784

Fax number:
919-220-6971

Pennsylvania:
Center:
Orthopaedic Speciality Center

Primary investigator:
Guy Lee, MD

Address:
2400 Maryland Road, Suite 20
Willow Grove, PA 19090

Coordinator contact:
Antoinette Bailey

Phone:
215-830-8700 x3121

Fax:
215-830-3058

Email:
abailey@oscdoctor.com

Website:
www.oscdoctors.com

South Carolina:
Name of center:
Spine

Primary investigator:
Jeffrey K. Wingate, MD

Location:
887 Johnnie Dodds Blvd., Suite 100
Mt. Pleasant, SC 29464
Contact name:
Celeste Cornish, RN

Phone number:
843-388-0606

Fax number:
843-388-0607

Texas:
Center:
Texas Back Institute

Primary investigator:
Michael Hisey, MD
Address:
6300 West Parker Road
Plano, TX 75093

Coordinator contact:
Tessa Bolt, CMA, CCRC

Phone:
972-608-5193

Email:
tbolt@Texasback.com

website:
www.texasback.com

Center:
Central Texas Spine Institute

Primary investigator:
Randall F. Dryer, MD

Address:
6818 Austin Center Blvd., Suite 200
Austin, Texas 78731

Coordinator contact:
Amy Sasser

Phone:
512-217-2719

Fax:
512-374-1077

Email:
asasser@pqrinc.com

Website:
www.spine-ctsi.com
——————————————————————————–

The information provided by Spine-Health in this Clinical Trials listing section is designed to help patients find clinical trials that are ongoing in the field of spine medicine, and to provide information to help patients contact the centers conducting the research. Spine-Health is not involved in conducting any of these trials and is not promoting the trials or research.

This is a listing of industry-sponsored clinical trials that are actively recruiting patients. These clinical trial listings are not edited or peer-reviewed by Spine-health.com.

INFORMATION SOURCE:http://www.spine-health.com/research/trials/dynesys/dynesys01.html

A physician once said to me, “If a physician is smart, he will know that a Case Manager is his best friend.” What did this physician know and understand about case management? Case Management is a relatively new discipline in nursing and is now being recognized for its importance as a valuable tool in the worker’s compensation claim. Some continue to misunderstand the role of the case manager and how their involvement impacts a file. Case Management historically was used for catastrophic cases, but as the impact on these cases was clearly seen, more and more it was learned that it could impact those less than catastrophic cases.

It is important to understand that the role of an effective Case Manager is not just to observe, record and report information. The Case Manager actively assesses and interprets the medical information for factors that have implications for the file. They look at all aspects of the file including medical, vocational, psychosocial, and situational factors that can affect the rehabilitation of the injured employee.

Case Managers are educators and motivators working constantly with the injured employee to educate them on their medical condition, treatment and what to expect. We spend so much time with the injured worker during physician appointments that we learn a wealth of information on their condition and perspective. We educate them on what is important to relay to their physician. By assuring they are educated on their condition and by motivating them in their recovery, they show an improved compliance and attitude with treatment and the worker’s compensation process, therefore, ultimately a more prompt closure and more optimal outcome to their injury.

Case Managers are facilitators that do not just schedule medical appointments. We review all of the factors and work as a team with the claims adjuster, injured employee, medical providers and employers to put together all of the pieces of the puzzle that will lead to an earlier return to work and improved outcome. When attending an appointment with the physician, I have reviewed all of the medical information, assessed the injured worker’s condition and attitude and have spoken with the employer to identify their regular job duties and modifications that are available for light duty. It is armed with this knowledge that I approach the physician appointment.

A Case Manager’s role is not to tell the physician what to do or how to treat their patient. One aspect of our role working with the physician in an appointment is to assure that he is informed of all the factors that can affect the injured workers progress in their rehabilitation. The physicians often look to the Case Manager for guidance in the employer’s ability to return the employee to light duty and for assistance with facilitating the medical recommendations promptly. We assess the treatment recommendations of the physician to determine if they are appropriate for this injured worker’s work related condition. The Case Manager is assessing whether there are other options available that would be more cost effective while achieving the same outcome and we review these with the physician. Because Case Managers attend appointments with many different physicians, we have the unique opportunity to see other treatment options that have been successful or what did not work. We work with the physician to assist in determining causal relationship and assuring treatment is related to the current work injury versus pre-existing problems again by ensuring that he has the facts. It is common for an injured worker to tell the physician that he normally lifts one hundred pounds at work and that there is no light duty. However, because we have spoken to the employer, we are able to ensure that the physician has the facts on what the regular job really entails and what light duty options might be available.

Most case managers are Registered Nurses with a broad range of experience and knowledge. An RN fresh out of nursing school simply would not have the experience and the knowledge that comes with that to effectively case manage. Because of their experience and knowledge, a Case Manager can be vital in assuring that the medical care is progressing effectively and identifying problems related to that care. We recently had a file handled by our case manager, Laurie, who had an injured worker with a fractured hip and wrist and was treating with a surgeon in another town. The injured worker continued to complain of severe hip pain, however, the physician focused only on that he was taking too many pain medications. From an outside perspective and after reading the physician’s dictations, it appeared that this injured worker possibly had drug dependence issues or was just “whiny”. However, because Laurie was at the appointments and because of her experience and knowledge, she was able to identify that there was most likely a potential medical problem that was not being addressed. She promptly obtained another opinion with a quality trauma surgeon who determined that this patient’s hardware was backing out and his hip fracture was displacing. He replaced the hardware within a week and the patient was on his way to progressing in his rehabilitation. Both her knowledge and experience led to Laurie being able to actively move this case forward saving additional weeks of TTD and wasted therapy. This is not an unusual scenario with case management. It happens frequently.

Case Managers are creative problem solvers. Again, experience and an inner drive to solve problems leads to some very creative solutions. I once had a file where a worker had a serious construction accident and was in a rehabilitation facility. To be discharged she would require a wheelchair ramp at her home. I made several calls to obtain rates, which were exorbitant, not to mention that it would be several weeks before the ramp could be built. Because this employee worked for a construction company and was very well liked, I was able to arrange for the owner to agree to have his other workers build the ramp at the cost of materials only. I obtained the specs for the ramp and several of the co-workers of this injured employee donated their time on a weekend to build a wheelchair ramp. The result? The injured worker was able to go home several weeks earlier than if we had to wait for a contractor to build the ramp. This saved several weeks of costs in a rehabilitation facility plus labor and retail costs of a contractor.

So what does the physician understand about case management? He knows that a case manager is there to be an objective third party that is uniquely experienced in medical, social, vocational, and situational issues. He knows that we are there to work as a team with him, the adjuster, and the injured worker with the common goal of achieving a safe and timely Return to Work and Maximum Medical Improvement.

The Indiana Supreme Court was recently asked to revisit the issue of whether a heart attack suffered by an employee while working was compensable under Indiana worker’s compensation law. The case was Bertoch v. NBD Corp. and U.S. Security, Inc., 813 N.E.2d 1159 (Ind. 2004). In the Bertoch case, the Indiana Supreme Court reversed a decision by the Full Worker’s Compensation Board of Indiana and determined that an employee’s death by reason of a heart attack was sufficiently connected to his employment so as to allow the employee’s widow to recover worker’s compensation benefits. It is the purpose of this article to discuss the specifics of the Bertoch case and consider whether it signals a change in how heart attack cases are analyzed and decided in Indiana.

Before discussing the Bertoch case and related issues, it is instructive to first (and briefly) review the manner in which heart attack cases in Indiana have historically been analyzed. The starting point for this review is the case of United States Steel Corporation v. Dykes, 154 N.E.2d 111 (Ind.1958). The employee in the Dykes case had a job that involved heavy lifting and a considerable amount of physical activity. On the day in question, the employee was fine when he got to work but, after working for a few hours, he collapsed and died. There was no evidence that the employee had an increased workload that particular day. The cause of the employee’s death was determined to be coronary heart disease that was of longstanding duration.

The issue, in the Dykes case, was whether the employee’s heart attack was compensable under Indiana worker’s compensation law. The Indiana Supreme Court, in the Dykes case, determined that the employee’s heart attack and consequent death was not a compensable event. In coming to this conclusion, the Court relied upon I.C. Section 22-3-2-2, which states that entitlement to worker’s compensation is conditioned upon injury or death “arising out of . . . employment”. The Court, in Dykes, reasoned that this “arising out of” language necessitates something more than the performance of the employee’s usual and routine tasks to render a heart attack compensable. The Court viewed the compensability issue as one involving causation, that is, whether the employee’s heart attack resulted from an increase in the workload beyond the employee’s heart’s ability to function or whether the heart attack was brought on simply by a decrease in the employee’s heart’s ability to meet an unchanged demand at work. The Court, in Dykes, determined that it was the latter and ruled that the employee’s heart attack did not arise out of his employment and was, therefore, not compensable under Indiana worker’s compensation law.

It is worthwhile, from a historical perspective, to next consider the case of Harris v. Rainsoft of Allen County, Indiana, 416 N.E.2d 1320 (Ind.App.1981). This case involved a situation where an owner/employee of a business suffered a heart attack on the day that his business was damaged by fire. The employee/owner had a history of heart disease and had, previous to his death, suffered a heart attack. Nevertheless, the Court, in the Harris case, ruled that the owner/employee was entitled to death benefits under Indiana worker’s compensation law. In so ruling, the Court recognized that the fire was an event that exceeded the normal work routine for the owner/employee. The Harris case did not break new ground because, like the Dykes case, the Court looked for (and found) a stimulus beyond regular work, namely, a fire at the owner/employee’s business premises. Nevertheless, the Harris case is generally viewed as one that pushed the compensability envelope in that the stimulus that caused the heart attack was not physical but emotional. More specifically, it was not the physical exertion of fighting the fire that caused the work injury but, rather, the shock and emotional distress of the fire itself.

It should be noted that both of these cases, Dykes and Harris, have, on occasion, been criticized because they purport to require that a compensable heart attack be the result of an accident. However, a close reading of these decisions shows that the focus is not on an accident but, rather, whether the heart attack arose out of employment, which is, essentially, a causation issue. The message of Dykes and Harris is that causation requires more than that the heart attack occurred at work.

This same approach was followed in another heart attack case decided approximately thirteen years ago, Jablonski v. Inland Steel Co., 575 N.E.2d 139 (Ind.App 1991). In the Jablonski case, the employee was sitting at his desk working when he began having chest pains and breathing difficulties. An ambulance was called and the employee was transported to the hospital. En route, the employee became unconscious and he died soon thereafter. The employee was only 37 years old and he had no history of heart disease. However, it was later determined that the employee died from a heart attack and that he suffered from various undiagnosed heart ailments. In the Jablonski case, the Indiana Court of Appeals determined that the heart attack suffered by the employee did not arise out of his employment. In coming to this conclusion, the Court relied heavily upon the fact that the employee was performing his usual everyday tasks when he began having chest problems and that there was no work event or stimulus (physical or emotional) that created additional strain on the employee’s heart.
This same rationale justified a finding of non-compensability in Smith v. Bob Evans Farms, Inc., 754 N.E.2d 18 (Ind. App. 2001). The Smith case dealt with a heart attack suffered by an area director for the Bob Evans Restaurant chain during a working lunch with other employees. The Indiana Court of Appeals, in Smith, determined that the employee was not entitled to worker’s compensation benefits because the employee was doing nothing out of the ordinary when the heart attack occurred. Again, compensability required something more than the fact that the heart attack occurred at work.

Which leads us to the most recent appellate court decision involving a heart attack, that is, the aforementioned Bertoch case. In Bertoch, the employee in question was working as a security guard at a building where a fire had broken-out. The employee was found dead on a landing between floors by fire and rescue personnel. It was determined that the employee died from cardiac arrest. The evidence was conflicting as to whether the employee died while engaged in an effort to alert someone to the fire or extinguish same. The Single Hearing Member of the Indiana Worker’s Compensation Board awarded benefits to the employee’s widow, finding that the employee’s death arose out of his employment. The Full Worker’s Compensation Board reversed this decision, finding that the employee’s death was not clearly connected to his work-related activities as a security guard. The Full Board ruling was affirmed on appeal to the Indiana Court of Appeals. An appeal to the Indiana Supreme Court followed and the Indiana Supreme Court reversed the Full Board decision.

The Indiana Supreme Court, in Bertoch, determined that the employee’s heart attack was a compensable event under Indiana worker’s compensation law. While acknowledging that the employee had significant preexisting heart disease, the Court found that the fire and the employee’s reaction to it was the causative event with respect to the heart attack. The Court, furthermore, determined that this event was sufficient to meet the “arising out of” requirement to render the heart attack compensable.

This ruling in the Bertoch case does not appear to change the essential causation requirement of previous heart attack cases–that there must be something more than the usual employment routine to render a heart attack compensable. After all, a fire is something out of the ordinary. While it would be anticipated that a security guard would be required to deal with situations that might be inherently stressful, such as break-ins and other types of mischief, it is more probable that the duties would be considerably more mundane, such as checking to see whether doors were locked, whether lights are turned off and whether tenants have signed in-and-out of a building. Presumably, if the security guard in the Bertoch case had simply suffered a heart attack while engaged in his normal rounds, there would be no compensable event under Indiana worker’s compensation law. This was not the situation. In Bertoch, there was a fire and this would be expected to increase the stress and anxiety of any one in the building, including the security guard (particularly if the security guard became engaged in efforts to quell the flames). This is exactly the type of stimulus, over and above normal work activities, that courts have historically focused on when analyzing the compensability of a heart attack. Thus, as noted above, the ruling in the Bertoch case does not appear to have broken any new ground in the realm of heart attack cases. In fact, it is very similar to the Harris case, decided back in 1981 and discussed previously herein, involving a situation where the owner/employer suffered a compensable heart attack when his business burned.

There are a couple of troubling aspects to the Bertoch case. First, like several previous cases, it misinterprets the Dykes decision by stating that Dykes stands for the proposition that a heart attack, to be compensable, must be preceded by some untoward or unexpected accident. As discussed previously herein, Dykes does not require an accident (at least not in so many words). The Dykes case (like many other heart attack cases that followed, including Bertoch), does, however, require that there be some causative element over and above the normal work routine in order to render a heart attack compensable under Indiana worker’s compensation law.

Perhaps a more troubling aspect of the Bertoch case is the Indiana Supreme Court’s willingness to reweigh evidence and judge credibility of witnesses, in disregard of its own admonition that it should not do so. In Bertoch, the Indiana Supreme Court took issue with the finding of the Full Worker’s Compensation Board that the employee’s heart attack could have occurred at any time (including at home) and that it was simply a coincidence that the heart attack occurred at the time of the fire. As stated above, the Indiana Supreme determined that the fire was the event that caused the employee’s cardiac arrest. This determination was a factual one and was contrary to the Full Board’s findings in that regard. This area should have been off-limits to the Indiana Supreme Court.

These criticisms aside, the fact remains that after Bertoch, causation, as a required element of proof in heart attack cases, is alive and well. By so ruling, the Indiana Supreme Court has reaffirmed a fundamental precept of the Worker’s Compensation Act, which is that it is not intended to provide a remedy to an employee for injuries or conditions resulting from risks which do not have their origin in occupational activities. Following Bertoch, it is still incumbent upon the worker to establish, from a medical and/or factual standpoint, that there was some event or stimulus, beyond the normal work routine, that resulted in the heart attack. Stated another way, a heart attack still is not deemed compensable under Indiana worker’s compensation law simply by showing that it occurred while the employee was at work.

The Centers for Medicare and Medicaid Services (CMS) recently began a comprehensive effort to reach out to the workers’ compensation industry in order to clarify Medicare Secondary Payer (MSP) policy and operational issues. Outreach initiatives include hosting MSP Open Door Forums, establishing a national “central case control” system to handle allocation submissions, hiring a review contractor and sponsoring a national educational tour to ensure that a consistent message is being delivered. While some of these CMS initiatives may appear to further hinder the settlement process by way of added bureaucratic layers, establishing a consistent methodology to address MSP issues should be helpful to the industry in the long run.

CMS piloted the first Medicare Secondary Payer Open Door Forum October 20, 2003 in Washington, D.C. The conference was well attended with 1200 callers participating during peak time. Participants raised many questions pertaining to Medicare Set-Aside (MSA) allocations. Paul Olenick, Division Director, CMM, Central Office in Baltimore addressed more issues at the second MSP Open Door Forum held on January 8, 2004.

The October and January forums were collectively productive in that four “top issues” surfaced, and various parties voiced their concerns and suggestions about efficiently processing allocation submissions.

Issue #1 Proper procedure for claims that do not meet CMS review thresholds at the time of settlement
Medicare’s interests must always be considered. An MSA arrangement is appropriate for Medicare beneficiaries at the time of settlement, regardless of the amount of the settlement. However, to determine if an MSA arrangement is appropriate in a workers’ compensation settlement involving an individual who is not yet a Medicare beneficiary, the following threshold criteria must be met:

• The total settlement is greater than $250,000 AND
• The claimant is reasonably expected to become a Medicare beneficiary within 30 months of the settlement date

According to CMS: “If both of the threshold criteria are not met in a settlement involving an individual who is not yet enrolled in Medicare, a CMS approved Medicare set-aside arrangement is not necessary and Medicare will make payments for workers’ compensation services that are otherwise reimbursable under Medicare once the individual enrolls in Medicare even when funds still remain in the individual’s settlement.”

Issue #2 The use of workers’ compensation fee schedule versus full actual charges
Paul Olenick stated that if a workers’ compensation (WC) fee schedule is to be used to compute the allocation, “…the settlement agreement must contain specific provisions that establish that the workers’ compensation carrier can and will ensure that the arrangement cannot be charged more than what would normally be payable under the workers’ compensation plan.” Participants were directed to the CMS memorandum released July 23, 2001 (question nine). According to the memo, “…it is important to note that when an arrangement’s settlement agreement does not contain specific provisions ensuring that providers, physicians and other suppliers cannot bill the arrangement more than the WC fee schedule amounts, then the regional office must review the sufficiency of that particular arrangement based upon full actual charge estimates.”

Issue #3 Whether or not professional administration fees can be extracted from the corpus of the Medicare Set-Aside account
According the CMS policy memorandum released May 7, 2004, “Administrative fees/expenses for administration of the MSA Arrangement and or attorney costs specifically associated with establishing the MSA Arrangement cannot be charged to the set-aside arrangement.”
CMS considers these costs to be part of the settlement negotiations and they must be paid from a source that is “completely separate from the Medicare set-aside arrangement funds.”

Issue #4 The correct method to index the MSA allocation for inflation
Determining and applying medical inflation factors for allocations is a hotly debated issue. Olenick referred to the July 23, 2001 CMS memorandum that requires inflation indexing for Medicare set-asides.

The Centers for Medicare and Medicaid Services received input from a variety of sources stating that because workers’ compensation carriers are not required to index medical inflation factors when settling a claim, indexing should not be required for MSA allocations. Since medical goods and services inflate at different rates, determining the rate of inflation appropriate for an individual case becomes challenging. Parties involved in MSA arrangements are requesting a consistent methodology for indexing inflation and applying interest discounts. To date, CMS has not fully resolved this issue. (The Philadelphia Regional Office currently requires an index rate of 4.4 percent and a discount factor of 3 percent for submitted allocations.) Olenick said that CMS is working to develop an easy and proper way to apply medical inflation factors to an MSA allocation.

Input on this topic is welcome and CMS established an email address for that purpose: mspcentral@cms.hhs.gov

Will the Medicare Drug Benefit impact allocations? 
While these four issues appear to be the priority for CMS, ramifications from recent legislation approving a Medicare drug benefit effective in January 2006 will also have to be addressed.
Should the cost of prescription drugs be included in the MSA allocation? The drug benefit program is elective and beneficiaries will pay premiums; if prescription drugs are included in an allocation effective 1/1/06, would the beneficiary be forced to enroll in the prescription drug program in order to use funds set aside in the allocation? At this time, CMS does not require a proposed MSA allocation to include or make allowances for the new Medicare drug benefit. Policy decisions regarding this issue will be applied to future allocations, not to those already approved.

Clearing the submission path
In order to expedite the submission process, all workers’ compensation MSA proposals should be sent to a central location as of May 1, 2004. The Coordination of Benefits Contractor (COBC) will ensure all necessary documentation is included in allocation submissions. The contractor does not actually perform the reviews; if the package is complete, documents will be scanned and forwarded electronically to the appropriate regional office for approval. If a submission is incomplete, it will be returned to the submitting party. There are concerns that a centralized review unit will result in additional delays. This may be justified because if a submission is sent directly to a regional office, the regional office has been instructed to route it to the COBC, and that could further delay approval by weeks.

Another challenge for this new “joint venture” is the backlog of cases that the review contractor is tackling. Last year, CMS hired a contractor to begin reviewing proposed allocations submitted to CMS prior to October 1, 2003. That process began in November and as of early January, only 120 submissions out of 640 cases were completed. During the process, the contractor found that 70 percent of the submissions required more information, contributing greatly to the delays. Parties involved in submitting allocations voiced concern about the timeliness of reviews and whether the contractor had adequate staffing and experience for efficient processing. CMS admits that there is a “learning curve” but feels that the contractor has adequate manpower to review the proposals and handle the sizable workload.

Send proposed allocations to:
CMS
C/o Coordination of Benefits
P.O. Box 660
New York, NY 10274-0660
Attention: WCMSA Proposal

CMS uses cross matching to identify double payments 
CMS has implemented a system to identify Medicare beneficiaries who have also filed a WC claim. This system cross matches CMS records with those in state Worker’s Compensation databases.

Moving toward a better system
While today’s submission process to CMS may seem to be a hindrance, hopefully the concentrated outreach efforts by CMS will positively impact the workers’ compensation industry and protect Medicare’s interests at the time of settlement. Will it all make a difference? For those involved in the workers’ compensation industry trying to comply with Medicare Secondary Payer policy and follow CMS direction, the initiatives are welcome but there’s a long way to go. CMS wants the dialogue and progress to continue. During the 2004 calendar year, CMS will sponsor a national tour to present “set-aside basics.” In addition, MediPro Seminars, LLC (www.mediproseminars.com) sponsored a program to address a number of issues surrounding Medicare Secondary Payer provisions on June 23-25 in Atlanta. The event featured industry experts including staff from the CMS Atlanta Regional Office and Central Office in Baltimore.

Barbara Fairchild, RN, BSN is the Director of Product Development for NuQuest Resources, Inc., a subsidiary of Protegrity Holdings, Inc. NuQuest is a national provider of Medicare Set-Aside Allocation (MSA) services, medical and vocational disability management and other specialized services. You can reach Barbara at toll free: 866-858-7161 or at bfairchild@MyNuQuest.com.

This article is being reprinted with the permission of NuQuest Resources

Ms. Lesina has made Indiana State University her home for the last three years.  Currently she is an accounting major/insurance minor junior and plans on graduating in May of 2006. Besides working full time and taking 12 credit hours, she volunteers to tutor accounting students every week.  This past April she was initiated into the Beta Alpha Psi Business Fraternity for Accounting and MIS students.  She looked forward to becoming a member as she had been attending their meetings for over a year prior to becoming an inductee.
Ms. Wiggins is a sophomore majoring in Finance with an Insurance and Risk Management minor. She is considering this to change and have a double major.  She is involved in several organizations on campus.  Her future school plans include obtaining an MBA and possibly a law degree. Insurance is a passion of hers, however, she is still determining how best to use the insurance skills she is learning while an undergraduate.

Winter weather is here! Did you know that hypothermia can occur any time of the year? Most cases of cold stress develop in air temperature between 30 and 50 degrees Fahrenheit. Actually, hypothermia occurs most often in the spring and fall, rather than winter. Anyone exposed to lower temperatures are at risk for cold related injuries.

Four factors contribute to cold stress: cold temperatures, high or cold wind, dampness, and cold water. In a cold environment, most of your body’s energy is used to keep you internal temperature warm. Your body shifts blood flow from your extremities (hands, feet, arms, and legs) and outer skin to the core (chest and abdomen). This allows your exposed skin and extremities to cool rapidly and increase the risk of frostbite and hypothermia. Although the elderly and those taking certain medications are at greater risk, anyone working in a cold environment may be at risk.

Occupational Safety and Health Administration (OSHA) suggests protecting workers by training the workforce about cold-induced illnesses and injuries. This training may include educating workers about the need to layer clothing, drink warm liquids, use the buddy system, and to take breaks in warm dry areas. Employees most also recognize the environmental and workplace conditions that lead to potential cold related illnesses and injuries.

Sitting on a toilet is a relaxing experience, usually. It wasn’t for the first sacroiliac injury I ever treated. She was a rotund young lady in her mid-twenties. While sitting on a commode in a luxury hotel, it came unbolted from the wall whereupon she and the bowl landed on the floor. She sustained a left sacroiliac strain from this, which unfortunately led to chronic sacroiliac pain, sacroiliitis. She subsequently had a significant (perhaps excessive) course of evaluation, treatment, disability claims and litigation. I distinctly recall feeling sorry for that hotel chain, let alone myself and the other physicians from whom she sought care.

Imposter? Better said, the differential diagnosis of medical problems or injuries than can cause similar signs and symptoms is extensive. This is because the locations of pain and radiation can differ among patients, and vary for a single patient. Inflammatory and seronegative arthropathies, lumbar radiculitis, degenerative disc disease, spondylosis, spondylolysis, sacral fracture, metastatic disease, pelvic pain, (e.g., uterine fibroids), can all have similar presenting symptoms. It can accompany mechanical imbalance, such as that seen with leg length discrepancies, scoliosis, spasticity, etc. Because symptoms are obscure and diagnosis challenging, expensive testing is usually non-diagnostic and ill-defined treatment often unsuccessful. Patients often have had extensive evaluations, MRI’s, EMG’s, etc, without clarification of the problem.

Sacroiliac strain/dysfunction should be in the mind of the examiner for any patient with sciatica, i.e. lumbar pain and leg pain. One of my favorite teachers in medical school, someone very good at physical examination, told us one day, “you can see the same things I see, if you look for them.” If not considered, the diagnosis will be missed. There will usually be a historical event, perhaps repetitive, of differential rotational force across the pelvis. Pertinent negatives should exclude other, non-occupational, medical conditions that can imitate the same symptoms. I’ve listed some of those conditions I’ve seen in practice, above. On exam, specific tenderness over the sacroiliac joint it usually (not always) present, and Patrick and Gaenslen exam maneuvers can be supportive in the empiric diagnosis. Neurological, musculoskeletal, abdominal examinations should be negative. A fluoroscopically guided diagnostic injection of the sacroiliac joint provides the best diagnostic confirmation.

Special testing should include, lumbar X-rays to include oblique and flexion/extension views, lumbar MRI, and rheumatologic laboratories. These are to exclude vertebral compression fracture, spondylolisthesis, spondylosis, disc pathology, instability, and rheumatologic conditions. If complete pain relief is noted after an injection (a diagnostic response) is seen, but with rapid return of significant pain the same or next day, a bone scan or pelvic MR should be considered to exclude a pelvic/sacral fracture or other destructive pathology, if warranted by history or laboratory abnormalities.

Fluoroscopically guided sacroiliac injections provide diagnostic and potentially therapeutic benefit. With direct visualization, the joint can be anesthetized by injection, plus corticosteroid can be delivered simultaneously. Complete or near complete resolution of pain immediately, is considered diagnostic. Fluoroscopy is the only reliable way to inject the joint, as it provides real time confirmation of needle location by direct visualization. The sacroiliac joint can only be entered in the inferior third of the visualized joint on X-ray due to the many ligamentous attachments (see figure). This is very difficult to palpate except in the very thin. While blind injections can sometimes be effective, a recent study using post injection CT, suggests an 80% likelihood of missing the joint by blind injection. This is clearly unacceptable in the management of personal or occupational injuries.

Treatment should include non-opiate analgesics, physical therapies for pelvic stabilization (preferably with a therapist having an interest in this type of injury), and sacroiliac supports can be useful for some patients. Work restrictions should limit bending at the waist, squatting, and climbing. Naturally, this is amended based on clinical progress and the patient’s occupation. A functional capacity evaluation may be necessary if there are concerns as to whether the patient is able to match his/her job description. Maximal medical improvement can be reached in four to six weeks, if not sooner, in my experience. If there are persisting symptoms, a small permanent partial impairment rating of one to three percent is not unreasonable.

While in college, I strained my right sacroiliac joint running up a staircase, skipping steps with each stride. It was extremely painful. I could barely walk on it for several days. Thankfully, it resolved with self-treatment and exercise. I wish I could say this is always the case. My experience is that the natural history of the injury is highly variable and essentially patient specific. Some people get over it, some get better, and some don’t.

Sacroiliitis is in part a diagnosis of exclusion. If suggested by history, exam, and in the absence of an obvious source for the patient’s symptoms otherwise, a diagnostic sacroiliac injection should be considered. If the diagnosis is confirmed, reasonable treatment can be completed expeditiously. If the injection is non-diagnostic, it’s on to the next item on your differential. Arriving at the correct diagnosis is the first step to successful treatment.

I cannot forget the first patient I treated with post-traumatic sacroiliitis. Nor can I forget my own experience with sacroiliac pain. One thing is sure. Whenever I go to a public restroom, I first look to make sure the commode is securely fastened to the floor.

Dr. Bergeron is board certified in Physical Medicine and Rehabilitation and Pain Medicine. He has recently relocated from Terre Haute to Indianapolis.

New Location:

Joseph W. Bergeron, M.D.
9292 N. Meridian St., suite 111
Indianapolis, IN 46260
Phone (317) 705-0909
Fax (317) 705-0910

Do you know one of the secrets to the FASTEST injury recovery? KEEP YOUR APPOINTMENTS! It is essential to keep medical appointments at their scheduled time periods. Medical interventions are designed to try to speed up the healing process. Regular reassessments are needed to evaluate the effectiveness of the medications, icing, restrictions, splints, etc. and to decide if therapy could augment the process. Appointments are also timed for anticipated changes in symptoms and allow for assessment of the condition and any possible further diagnostic testing. If therapy is ordered, regular visits to therapy help to ensure that the injured worker has the most effective exercises and treatment. Delays in treatment increase the possibility of an injury that lasts longer and a slower than normal progression.

As an employer, you can help control the injury rate by creating an environment that supports compliance with appointments. Some suggestions are:

• Set the ground rules with the injured associate at the time of injury with the expectation that they are responsible for keeping their appointments. There may be a protocol that your company follows with specific directions spelled out for the injured worker to follow. Remember that restrictions have an expiration date.
• Assign a specific person to receive all paperwork from the medical clinic that should include documentation of their next appointment(s). Another recommendation is to make a copy of their appointment card(s) if they receive one. Require the return of paperwork be prompt. This will allow a second check on keeping track of appointments.
•  If an appointment time changes, the associate should be required to notify their company contact.
• As an employer, communicate with your injured worker about scheduling preferences that least disrupt the work environment. Scheduling during their work shift may help with morale and with compliance of keeping appointments. If you allow for appointments during work hours, it is fair to require the associate to try to schedule at a time that is least disruptive to the work environment.

Specific standards exist for approximately 30 substances that may be used or found in the workplace and to which employees may be exposed in the performance of their work:

Those substances include:

– Asbestos
– Coal tar pitch volatiles
– 13 carcinogens
– Alpha-Naphthylamine
– Methyl chloromethyl ether
– 3,3’ – Dichlorobenzidine
– Bis-Chloromethyl ether
– Beta Naphthylamine
– Benzidine
– 4- Aminodiphenyl
– Ethyleneieme
– Beta-Propiolactone
– 2- Acetylaminofluorene
– 4- Dimethylaminoazobenzene
– N- Nitrosodimethylamine
– Vinyl chloride
– Inorganic arsenic
– Lead
– Cadmium
– Benzene
– Cook oven emissions
– Bloodborne pathogens
– Cotton Dust
– Acrylonitrile
– Ethylene oxide
– Formaldehyde
– Methylenedianiline
– 1,3- Butadiene
– Methylene chloride

The standards generally define action levels and permissible exposure limits for each regulated substance. Equally important, additional comprehensive requirements generally exist for each substance with respect to:

– Employee monitoring, including frequency, procedures and notice to employees.
– Employee information and training.
– Engineering and work practice controls.
– Personal protective equipment (including respiratory protective equipment).
– Medical examinations for employees.
– Record keeping requirements.

Employers should determine if such substances are present in their workplaces. If so, they must carefully review the appropriate standards and take steps to ensure they are in compliance.

In 1994, OSHA published a proposed rule to regulate indoor air quality in non-industrial facilities, such as office building and health care establishments. The primary goal was to control exposure to second-hand cigarette smoke, but the proposal also addressed indoor air quality for carbon dioxide, spores, and fungi. OSHA recommends that employers who have indoor air quality concerns should conduct an indoor air quality investigation, which includes:

– Identification of pollutant sources
– Evaluation of the heating, ventilation and air conditioning HVAC system performance
– Observation of production processes and work practices
– Measurement of contamination levels and employee exposure
– Medical testing or physical examinations
– Employee interview
– Review of records of medical test, job histories and injuries and illnesses

For more information on indoor air quality or to find out the status of a proposed rule click on the link below.

http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=FEDERAL_REGISTER&p_id=13369

During the acute phases of a hand, wrist, or elbow injury or surgical procedure, the main treatment priority is to immobilize the injured body part in order to allow rest and healing. Occasionally, this can be accomplished through the use of “off the shelf” or prefabricated braces. Frequently however, such braces do not adequately immobilize the injury site due to the type of materials used and the fact that they are not custom fit to the patient. They may be uncomfortable or they may immobilize areas that need to be free to move.

Therefore, a custom splint is often fabricated by an occupational therapist that has received education on the theories behind splinting as well as training in splint fabrication skills. The occupational therapist is able to design a splint that meets the specialized needs of an individual patient. Most custom splints are fabricated from a thermoplastic material that can be heated, cut, and molded to the patient. The splint can be designed to immobilize only the structure that needs to be protected, while allowing adjacent joints to remain free. This means undue stiffness and swelling can be avoided and the patient is able to function more easily while wearing the splint.

When a patient receives a splint, he is also given specific instructions by the occupational therapist regarding wearing schedule, care instructions, and how to apply and remove the splint correctly. The therapist provides splinting instructions based on his or her knowledge of the diagnosis or surgical procedure and how far along the patient has progressed in the phases of healing. It is important that the patient follow these instructions to gain maximum benefit from the splint.

Typically, a patient is instructed to wear the splint at all times except during daily hygiene activities or during post-operative exercises as prescribed by the therapist. As a patient’s pain and swelling subside and the injury or surgical site is sufficiently healed, wearing time is gradually decreased. Use of the splint while at work is usually the last component of the splinting program to be weaned, since the work environment can sometimes be unpredictable and the patient can be at risk of re-injury.