Orthologix brings you quarterly information to keep you current on industry news, trends and insights. Orthologix is an orthotics and prosthetics practice delivering evidence-based care throughout the Delaware Valley.
Orthomerica® TC Flex™ AFO System
TC Flex™ is a uniquely progressive orthotic management system for children and adults with neuromuscular, sensory-motor, orthopedic, and physical challenges. These custom molded orthoses are designed to stabilize the structures of the foot and ankle complex to enable the patient to utilize current and potential muscle capabilities.
TC Flex™ designs are made from thin and flexible materials to allow patients to experience more normalized proprioceptive feedback, balance, and equilibrium mechanisms. Total contact modifications defined in the plantar surface stabilize the structures of the foot and provide neutral, midline stability. Flexible designs, precise modification, and consistent fabrication techniques promote functional bio-mechanical alignment and facilitate the appropriate use of available muscle power for functional activity. Each design is specific to help control unwanted motion, allow wanted motion, and distribute pressure to minimize break down.
TC Flex™ AFO System fits into the orthopedic category of total contact tone-inhibiting orthoses, commonly referenced as a dynamic ankle-foot orthosis (DAFO). Tone-inhibiting AFOs are widely used in patient care, especially in the pediatric population and prescribed in neurorehabilitation. Tone-inhibiting AFOs are not new to patient care and several case studies have been documented establishing the clinical effectiveness and benefits that make tone-inhibiting AFOs one of the most popular bracing designs.
TC Flex™ orthoses are separated into four categories to assist with differentiating each orthosis and understanding the recommended use.
- Group 1: Hind-foot control consists of orthoses that control the hind-foot and mid-foot position to provide a stable base of support.
- Group 2: Sagittal control contains orthoses that have varying levels of dorsiflexion and plantarflexion control without the use of articulating joints. Two of the designs in this group are two-part (combo) orthoses.
- Group 3: Articulated orthoses provide free dorsiflexion with limited or blocked plantarflexion through the use of hinges and plantarflexion stops.
- Group 4: Reactors consist of orthoses with the potential to block dorsiflexion or provide precise range of motion for both dorsiflexion and plantarflexion. Orthoses include solid articulated and adjustable strap.
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"Effect of a Tone-Inhibiting Dynamic Ankle-Foot Orthosis on the Foot-Loading Pattern of a Hemiplegic Adult: A Preliminary Study."
The Journal of Prosthetics and Orthotics, Vol. 4, No. 2, 1992
The dynamic ankle-foot orthosis is widely used, particularly in the pediatric population, and has several unique features. First, it allows graded foot motion within the orthosis so normal balance reactions involving proximal musculature can occur. Second, by providing support of the foot's natural arches, weight is more equally distributed throughout the foot. Thus, stimulation of foot reflexes better approximates normal function (6-8). Third, dynamic ankle-foot orthoses provide secure medial-lateral stability and midline positioning, resulting in improved grading of ankle plantar- and dorsiflexion. This stabilization has proven so effective, many clinicians have noted a decrease in abnormal plantarflexion in patients wearing dynamic ankle-foot orthoses. In one case, a 15-year-old spastic diplegic patient with a resistant heel-cord contracture gained 15 degrees of passive dorsiflexion with knee extension as a result of wearing dynamic ankle-foot orthoses for three months (4).
The clinical effects of management with dynamic ankle-foot orthoses are very promising. In one study, a four-year-old boy with spastic diplegia showed significant increases in the duration and efficiency of balanced standing when wearing dynamic ankle-foot orthoses as compared to his performance without these orthoses (5). In another study, the effects of dynamic ankle-foot orthoses were reported on a 69-year-old male who was 18 months post-CVA, who had no voluntary movement at the foot or ankle, and who demonstrated forceful hyperextension of the knee when wearing a conventional AFO (9). Within one month of receiving his dynamic ankle-foot orthosis, the patient demonstrated active toe extension and showed a 10-degree increase in knee flexion during toe-off. The author of this study attributed these improvements to the controlled mobility afforded by the dynamic ankle-foot orthosis. The effects of dynamic ankle-foot orthoses on the temporal variables of gait were reported in a single-subject study by Diamond (10). The subject, a hemiplegic adult, showed significant increases in velocity, step length and stance time when wearing a dynamic ankle-foot orthosis as compared to his performance when barefoot. Although all of these studies are single-subject designs, the author of one such study defended this methodology by stating: "The single-subject design is particularly appropriate for evaluating treatment effectiveness in neurologic patients because of the organic and behavioral variability of this disorder" (5).
To read the study, visit: www.oandp.org/jpo/library/1992_02_086.asp.
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"Effect of a Tone-Inhibiting Dynamic Ankle-Foot Orthosis on Stride Characteristics of an Adult with Hemiparesis"
Journal of the American Physical Therapy Association Vol.70, No.7, July 1990
A single-subject, alternating-treatment design was used to investigate differences in stride characteristics of a hemiparetic subject under three conditions: 1) barefoot, 2) using a prefabricated plastic molded ankle-foot orthosis (AFO), and 3) using a tone-inhibiting dynamic ankle-foot orthosis (TIAFO). Five barefoot baseline sessions were conducted. Following these baseline sessions, the three conditions were randomly varied during each of 12 alternating treatment sessions. Data analysis revealed a significant improvement in walking velocity, step length, and stance time on the hemiparetic limb and a significant decrease in cadence when either the AFO or the TIAFO condition was compared with the barefoot condition. The TIAFO was associated with a significant increase in walking velocity and step length when evaluated against the prefabricated AFO. The subject reported that use of the TIAFO increased his ability to ambulate distances and that the TIAFO was more comfortable and less restrictive than the prefabricated AFO. The results suggest that the TIAFO may be a promising alternative to conventional orthotic management of adults with hemiparesis
To read the study, visit: http://ptjournal.apta.org/content/70/7/423.full.pdf.
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James A. Blackman, M.D., M.P.H.
Director of the Cerebral Palsy International Research Foundation (CPIRF)
James A. Blackman, M.D., M.P.H., is director of the Cerebral Palsy International Research Foundation (CPIRF). Dr. Blackman develops CPIRF’s research and educational strategies in addition to coordinating the research grant peer review process with the Scientific Review Committee (SRC). He works closely with leaders from within the scientific, governmental, and CP/disabilities communities to facilitate and enhance the Foundation’s domestic and global research and educational partnerships.
Dr. Blackman is Professor Emeritus of Pediatrics at the University of Virginia, where he served more than 20 years, most recently as Head, Division of Developmental Pediatrics and Medical Director of the Kluge Children’s Rehabilitation Center. He is also past president of the American Academy for Cerebral Palsy and Developmental Medicine. Among his research interests, he has received funding from the NIH to study the role of the Apolipoprotein E gene in cerebral palsy with collaborators from Australia and Norway.
Dr. Blackman has more than 30 years experience in education, research and, most importantly, clinical work with individuals with cerebral palsy and their families. “I would like to use this experience to continue the outstanding work of the Foundation in promoting new knowledge into the causes, treatments and quality of life issues of cerebral palsy. However, an important aspect of my job is to explore new research directions for the Foundation in collaboration with national and international partners, the Board of Directors, UCP affiliates, and persons with cerebral palsy and their families. I welcome ideas and advice from any source and look forward to a very exciting and productive association with CPIRF,” he said.
He received his medical degree at The Ohio State University, completed pediatrics residency at the University of Michigan and Fellowship in Developmental/Behavioral Pediatrics at Harvard University (Children’s Hospital, Boston). He also has a Master of Public Health from San Diego State University.
He has won various honors and fellowships including the Hanlon Outstanding Public Health Graduate Award and a Mary E Switzer Distinguished Fellowship from the National Institute on Disability and Rehabilitation Research. He has published widely, in both books and journals.
Dr. Blackman will post articles on the CPIRF website. His first article describes current thinking related to use of Constraint-Induced Movement Therapy (CIMT), also called Constraint-Induced Therapy (CIT).
This article can be found at http://www.cpirf.org/stories/2510.
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Fair Physical Therapy Copays
With an increasing concern regarding out-of-pocket expenses for health care, many chapters are supporting and advocating for fair physical therapy copayments. Copayments may deter patients from seeking proper treatment or encourage them to reduce the frequency of care. Under some health plans, copayments for physical therapy services can reach $60 per visit.
Physical therapy is often listed under the specialist classification, which enables health plans to impose a higher specialist copayment instead of the lower primary care copayment. Other services in this category include cardiologists, neurologists, and anesthesiologists, which often require fewer visits than physical therapy.
The American Physical Therapy Association supports legislation by chapters that provides for fair physical therapy copayments and prevents the financial burden that exists when a physical therapist is under the specialist category. For more information and resources, visit http://www.apta.org/StateIssues/FairCopays/.
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CMS Proposes Definition of Stage 2 Meaningful Use of Certified Electronic Health Records (EHR) Technology
The Centers for Medicare & Medicaid Services (CMS) announced a proposed rule for Stage 2 requirements for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. Under the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of American Recovery and Reinvestment Act of 2009, eligible health care professionals (EPs), eligible hospitals and Critical Access Hospitals (CAHs) can qualify for Medicare and Medicaid incentive payments when they adopt certified EHR technology and use it to demonstrate “meaningful use” of that technology by achieving objectives set by CMS.
This fact sheet summarizes CMS’ proposed requirements for Stage 2 of the Medicare and Medicaid EHR Incentive Programs.
Meaningful Use – Policy Goals and Definition
Through the Stage 2 requirements of the Medicare and Medicaid EHR Incentive Programs, CMS hopes to expand the meaningful use of certified EHR technology. Certified EHR technology used in a meaningful way is one piece of a broader Health Information Technology infrastructure needed to reform the health care system and improve health care quality, efficiency, and patient safety.
On July 28, 2010, CMS published a final rule entitled “Medicare and Medicaid Programs; Electronic Health Record Incentive Programs” (75 FR 44313 through 44588) that specified the Stage 1 criteria eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must meet in order to qualify for an incentive payment, calculation of the incentive payment amounts, and other program participation requirements. In that final rule, we also detailed that the Medicare and Medicaid EHR Incentive Programs would consist of 3 different stages of meaningful use requirements, with each stage requiring increasing use of EHRs and electronic information exchange.
Stage 2 Criteria for Meaningful Use
In this proposed rule CMS proposes to specify Stage 2 criteria that EPs, eligible hospitals, and CAHs must meet in order to qualify for an incentive payment, as well as introduce changes to the program timeline and detail payment adjustments. These proposed criteria were substantially adopted from the recommendations of the Health IT Policy Committee (HITPC), a Federal Advisory Committee that obtains industry and provider input regarding the Medicare and Medicaid EHR Incentive Programs, as well as through consideration of current program data for the Medicare and Medicaid EHR Incentive Programs. The proposed Stage 2 criteria for meaningful use focus on increasing the electronic capturing of health information in a structured format, as well as increasing the exchange of clinically relevant information between providers of care at care transitions.
The proposed Stage 2 criteria for meaningful use are based on a series of specific objectives, each of which is tied to a proposed measure that all EPs and hospitals must meet in order to demonstrate that they are meaningful users of certified EHR technology. This approach is similar to the objective and measure approach used in Stage 1.
In our July 28, 2010, rule outlining Stage 1 criteria, CMS finalized a separate set of core objectives and menu objectives for both EPs and eligible hospitals and CAHs. In Stage 1, EPs and hospitals must meet or qualify for an exclusion to all of the core objectives and 5 out of the 10 menu measures in order to qualify for an EHR incentive payment under these Stage 1 requirements.
In this proposed rule, CMS proposes to maintain the same core and menu structure for the program for Stage 2. We propose for Stage 2 that EPs must meet or qualify for an exclusion to 17 core objectives and 3 of 5 menu objectives. We propose that eligible hospitals and CAHs must meet or qualify for an exclusion to 16 core objectives and 2 of 4 menu objectives.
Each objective/measure was evaluated for its applicability to all EPs and eligible hospitals. In cases where there are situations that make it impossible for an EP or eligible hospital to meet the measure, an exclusion was defined in the final rule. If an exclusion applies, then the EP or eligible hospital would not have to meet that objective/measure in order to be deemed a meaningful user.
Nearly all of the Stage 1 core and menu objectives have been retained for Stage 2. The “exchange of key clinical information” core objective from Stage 1 was eliminated in favor of a more robust “transitions of care” core objective in Stage 2, and the “provide patients with an electronic copy of their health information” objective was eliminated because it has been replaced by an “electronic/online access” core objective. There are also multiple Stage 1 objectives that have been combined into more unified Stage 2 objectives, with a subsequent rise in the measure threshold that providers must achieve for each objective that has been retained from Stage 1. This eliminates unnecessary accounting and reporting burden for providers by recognizing that, for providers who have been Stage 1 meaningful users for multiple years, recording this data in structured form has become a normal part of care delivery.
Changes to Stage 1 Criteria for Meaningful Use
In this proposed rule, CMS proposes several changes to existing Stage 1 criteria for meaningful use. Some of these changes would be optional for use by providers in Stage 1 but would be required for use in Stage 2. Other changes would not take effect until providers have to meet the Stage 2 criteria. An overview of these proposed changes includes:
- Changes to the denominator of computerized provider order entry (CPOE) (Stage 1 Optional, Stage 2 Required)
- Changes to the age limitations for vital signs (Stage 1 Optional, Stage 2 Required)
- Elimination of the “exchange of key clinical information” core objective from Stage 1 in favor of a “transitions of care” core objective that requires electronic exchange of summary of care documents in Stage 2 (Effective Stage 2)
- Replacing “provide patients with an electronic copy of their health information” objective with a “view online, download and transmit” core objective. (Effective Stage 2)
Greater Applicability to Specialists
The NPRM proposes new objectives that have greater applicability to many specialty providers. The addition of these objectives recognizes the leadership role that many specialty providers have played in the meaningful use of health IT for quality improvement purposes with respect to:
- Imaging results and information accessible through certified EHR technology
- Capability to identify and report cancer cases to a State cancer registry, except where prohibited, and in accordance with applicable law and practice
- Capability to identify and report specific cases to a specialized registry (other than a cancer registry), except where prohibited, and in accordance with applicable law and practice
Stage 2 Reporting of Clinical Quality Measures
Just as in Stage 1, CMS proposes that EPs, eligible hospitals, and CAHs be required to report on specified clinical quality measures (CQMs) in order to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs.
For EPs, CMS is proposing a set of measures that align Stage 2 CQMs with existing quality programs by aligning measures with the Physician Quality Reporting System (PQRS), Medicare Shared Savings Program, and National Council for Quality Assurance (NCQA) for medical home accreditation, as well as measures proposed under the Children’s Health Insurance Program Reauthorization Act (CHIPRA) and under section 1139A of the Social Security Act (as added by Section 2701 of the Affordable Care Act). For eligible hospitals and CAHs, CMS is proposing to align Stage 2 CQMs with the Inpatient Quality Reporting (IQR) and the Joint Commission’s hospital quality measures. The proposed rule would require EPs to report 12 CQMs and eligible hospitals and CAHs to report 24 CQMs in total. CMS recognizes that for clinical quality reporting to become routine, the administrative burden of reporting must be reduced.
This proposed rule outlines a process by which EPs, eligible hospitals, and CAHs beyond their first year of Stage 1 participation would submit CQM data electronically, thereby reducing the associated burden of reporting on quality measures for providers. CMS is soliciting public comment on two mechanisms of electronic CQM reporting: aggregate-level electronic reporting as a group, or through existing quality reporting systems (for Medicare providers). Within these and States’ mechanisms of reporting, CMS has proposed different approaches to CQM reporting that offer flexibility to EPs, eligible hospitals, and CAHs.
Payment Adjustments and Exceptions
Medicare payment adjustments are required by statute to take effect in 2015. In this NPRM, CMS proposes that any Medicare EP or hospital that demonstrates meaningful use in 2013 would avoid payment adjustment in 2015. Also, any Medicare provider that first demonstrates meaningful use in 2014 would avoid the penalty if they meet the attestation requirement by July 3, 2014 (eligible hospitals) or October 3, 2014 (EPs). Meaningful use attestations to State Medicaid Agencies by EPs who are eligible for either Medicare or Medicaid but opted for Medicaid, will be accepted to avoid the Medicare penalty. However, it is important to note that the receipt of Medicaid EHR Incentive Program payments for one kind of Medicaid incentive payment (the adopt, implement or upgrade, the criteria for the first year of Medicaid EHR Incentive Program payments), is not the same as meeting the meaningful use criteria. Therefore, those providers may be subject to Medicare payment adjustments if they do not otherwise demonstrate meaningful use.
CMS is proposing exceptions to these payment adjustments. This proposed rule outlines three categories of exceptions based on:
- Availability of internet access or barriers to obtaining IT infrastructure;
- A time-limited exception for newly practicing EPs who would not otherwise be able to avoid payment adjustments; and
- Unforeseen circumstances such as natural disasters that would be handled on a case-by-case basis.
CMS is also soliciting comment on additional criteria for exceptions.
Extension of Stage 1
Finally, consistent with the November 2011 “We Can’t Wait” announcement, CMS is proposing an extension of Stage 1, so that providers have an additional year for implementation of Stage 2 criteria. In our July 28, 2010, rule, we established that any provider who first attested to Stage 1 criteria in 2011 would have to begin using Stage 2 criteria in 2013. This proposed rule delays the onset of those Stage 2 criteria for those providers until 2014, which CMS believes would allow the needed time for vendors to develop Certified EHR Technology that can meet the Stage 2 requirements proposed here.
CMS’ proposed rule may be viewed here: www.ofr.gov/inspection.aspx.
Additional information on the Medicare and Medicaid EHR Incentive Programs can be found at www.cms.hhs.gov/EHRincentiveprograms.
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Q & A
Please feel free to submit your questions on the TC Flex™ as well as any other issue you would like addressed.
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Educational Workshops and Inservices
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