Begin Summer Training by Understanding the History Components of Evaluation and Management

  • Gretchen Dixon, MBA, RN, CCS, CPCP, ICD-10-CM/PCS Trainer
  • Volume 08 - Issue 2

Summer is the time to relax and catch up on to-do list items. This fits in especially for the elements of clinical documentation in the Evaluation and Management (E/M) visit levels, which need reviewing.

Now is the time to focus on this troubled topic of Evaluation and Management as they affect the accuracy score for your visit levels. Some may feel like this is drudgery in action again when there is a request of the provider to either clarify or add details into the clinical documentation. By tweaking your clinical information through adding details, you may bring forward those misplaced or partially forgotten nuggets of value (details relating to the patient’s current visit).

The OIG in their 2017 Work Plan continues to monitor the data regarding the E/M levels billed, knowing our weak spots  in the clinical documentation. The accuracy score after an audit of your E/M documentation will provide either a benchmark or validation of the compliance with clinical documentation expectations. These expectations are clearly documented by the Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) with their Evaluation and Management Service guide, which is updated annually, with August 2016 as the most recent.

Take time to review your accuracy score. If it is below 90%, have your coder take a sample of five of your medical records, reviewing to validate the level of clinical documentation in supporting the level of billed services.

NOTE: Even though there is complete clinical documentation by the provider, the documented information may not be sufficient or relevant to explain medical necessity to government attorneys and auditors.

Think of establishing 90% as a goal for your suggestions on how to improve your clinical documentation details, thus supporting the most accurate E/M visit level based on the patient’s medical necessity.

Before starting any type of documentation, THINK-N-INK: “If it is not documented, it was not considered or not done.” This sounds simple, but with today’s busy practice, staff may forget to document thoughts or misplace notes — paper scratch notes may get lost or, worse, documented on the wrong patient’s chart. It happens more frequently than you may expect.

Using the E/M history documentation components, this article will describe what providers need to document by thoroughly recording specific clinical information relevant to the reason for the visit. To reiterate, all clinical information must be relevant to the reason for the visit.

FOCUS: The documentation of each patient encounter should include:*
  • Reason for the encounter (chief complaint) and prior diagnostic test results
  • Assessment, clinical impression or diagnosis
  • Medical plan of care
  • Signature and date of provider
    *Per DHHS and CMS Evaluation and Management Services, August 2016

Within the history component are four elements that should be completed to their highest level of documented clinical information relevant to the reason for the visit: chief complaint (CC) or reason for the visit, history of present illness (HPI), review of systems (ROS) and past, family, social history (PFSH). The history components can be documented separately by element or inclusive in the History of Present Illness, as long as they can be specifically identified by the reader.

Chief Complaint (CC) Establishes the Need for Medical Necessity

The chief complaint, considered stage one of two in identifying medical necessity, sets the stage for which all other components in the medical record must be relevant. The CC should be a concise statement in the patient’s own words describing the reason for his or her visit with the health-care provider. There should always be a documented statement from the patient for each visit.

Ensure there are specifics when documenting the CC. Avoid valueless CCs such as “here for follow-up,” “patient returns today,” “patient here for appointment” or “here for check- up.” Ideally the CC could be the patient stating, “I am here for a follow-up about last week’s MRI or test,” which would be considered appropriate.

FOCUS: Ensure the chief complaint is documented in the patient’s own words to establish the medical necessity of the visit.

History of Present Illness (HPI) Establishes Medical Necessity

Stage two provides the level of details supporting the need for medical necessity of the visit. The HPI provides the details of the condition by asking pointed questions to elicit patient responses relevant to the chief complaint. A chronological description of details about how the patient developed his or her present illness, the HPI should include the eight specific elements below. Each element is provided with but not limited to the following examples.

1, Location— area of the body, such as "lower right leg", or the site of problem or condition, always include documenting laterality when appropriate

2. Quality— the patient's description of the specific attribute or character of the symptom or condition

                     a. Pain, described as sharp, dull, throbbing, stabbing, constant, intermittent

                     b. Acute, chronic, stable, worse, scratchy

3. Severity— intensity, degree, measure of the symptom or condition

                     a. Rate pain on a scale of 1 to 10

                     b. Pain description: "Worse I have ever had" "Not bad," "Severe," "Getting to the point where I can't stand it"

4. Duration— length of time the symptoms or conditions have been present

5. Timing— the onset of the symptoms, or when they occur

                     a. Worse at night

                     b. Hurts all the time

                     c. Only at night

                     d. Starts when I sit for more than an hour

6. Context— surrounding events

                     a. Where the patient is and what the patient is doing when the symptoms/problems begin

                     b. Situational stress-anxiety episodes due to life event

7. Modifying factors— what was done to alleviate the symptom or problem when it happens

                     a. Ice pack or heat applied

                     b. Antibiotic cream

                     c. Tylenol for pain

                     d. Must lay down

8. Associated signs and symptoms— additional signs and symptoms related to or part of the patient’s problem(s) that may not fit in any of the other categories

 

The HPI often lacks the amount of details describing the history of the present illness that external auditors are beginning to focus on. In the wound care environment, there needs to be a consistency of documented details on the past treatments, interventions and other medical care provided to the patient for the specific condition to include both positive and negative outcomes. It is this level of detail that supports the medical necessity and demonstrates the higher level of acuity, complexity of care and intensity of services the patient requires.

Now with the understanding of the importance of setting and establishing the medical necessity for the visit with the CC and HPI, it is vital to recognize that all the other components in the E/M must be relevant to both items. Copying and or pasting past clinical information does not always provide the relevancy for the visit. This process may actually be detrimental to the content of clinical information.

The HPI is one area in which your E/M visit level may be down-coded a level during an audit.

FOCUS: 
  • Establishing medical necessity with clear and accurate clinical documented details of the patient's problem.
  • Review current documentation process to improve by adding value to the clinical information, ensuring all eight elements are included.

Review of Systems (ROS)

The review of systems is another component where  external auditors are beginning to focus due to recognizing another area in which clinical documentation  is  weak when validating the E/M visit level. The ROS entails inquiries or questions concerning the system(s) directly related to the problem(s) identified in the HPI. This is a different interpretation from the past, when all systems were identified either by the patient completing a dedicated form or the ancillary staff asking questions of the patient and documenting the patient’s response.

NOTE: Never record the phrase “no known allergies” in the ROS for the allergic system. It belongs under the patient’s past medical history in the PFSH element.

The HHS and CMS Evaluation and Management Services (published August 2015 and 2016, respectively) notes on page 7: “ROS inquiries about the system directly to the problem(s) identified in the HPI and a number of additional systems.”

FOCUS: Ensure credit is only for those systems relevant to the problems identified in the HPI.

Past, Family, Social History (PFSH)

Although this element is usually documented only at the time of the initial visit, if a patient is on medications that may change between visits, the medication list must be updated. If a follow-up visit results in an E/M, then the medication needs to be recorded under the past medical history.

FOCUS: Although a wealth of information is recorded in the PFSH element, take credit only for the information that is relevant to the problem(s) identified in the HPI.

Any relevant medical updates such as tests, interventions, and procedures since the last visit need to be included in the documentation. Additionally, when a patient advises of “no known allergies,” this is always considered a part of the patient’s past medical history.

In the past, we have been accustomed to taking credit for everything documented in this section whether it is relative or not to the reason for the visit. As stated in the HHS/CMS Evaluation and Management Services documentation guide, however, documenters are specifically notified that the PFSH is a review of the medical, family and social history areas directly related to the problem(s) identified in the HPI. Auditors will remove credit for information not relevant to the medical problem in the HPI.

Synopsis of History Elements

As you read through the above history elements, you should have discovered two common threads that must be followed to avoid overreporting of an E/M visit level. The first is establishing and validating medical necessity, and the second is ensuring all elements documented are relevant to the identified problem(s) in the HPI for credit of this component supporting the reported E/M visit level.

Irrelevant information added through the electronic health record (EHR) by the automatic populating option of copying and pasting past information into these components is easily discoverable. Often providers do it to try to save time from having to document similar information. If an audit discovers the irrelevant clinical documentation, the visit level may result in a lower visit level. Is this activity worth the risk? The risk is not only overcoding a visit level but also possibly having a pattern discovered, which may require an extensive retrospective audit, possibly validating a pattern of overbilling visit levels resulting in false claims. Now you have entered the realm of compliance issues involving not only governmental payers but also third party-payers.

Third party-payers are increasing their audits, picking up on what Medicare has audited for years knowing E/M levels supporting clinical documentation has a deep weakness, resulting in anticipating overpayments to be refunded. (Refer to the Federal Register dated February 12, 2016, titled “Medicare Program: Reporting and Returning of Overpayments; Final Rule.”)

Please click on the links below to register for one of our five- week webinar series on clinical documentation improvement so your medical decision-making is supported when providing patient care.

July 19: https://woundeducationpartners.com/live-courses/ billing-and-coding/204-essentials-of-icd-10-cm-coding-and- clinical-documentation-improvement-for-the-hyperbaric- team-5-day-series-4.html

Oct. 4: https://woundeducationpartners.com/live-courses/ billing-and-coding/205-essentials-of-icd-10-cm-coding-and- clinical-documentation-improvement-for-the-hyperbaric- team-5-day-series-2.html

 

Resources

American Medical Association. Statement of the American Medical Association to the Institute of Medicine’s Committee on Determination of Essential Health Benefits. 2011, January 14; p. 4. http://www.nationalacademies.org/ hmd/~/media/8D03963CAEB24450947C1AEC0CAECD85.ashx

Department of Health and Human Services, Centers for Medicare and Medicaid Services. Evaluation and Management Services. 2016 August. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/eval-mgmt-serv-guide-ICN006764.pdf

Department of Health and Human Services, Centers for Medicare and Medicaid Services. Laws Against Health Care Fraud Resource Guide. 2015 September. https://www.cms.gov/Medicare-Medicaid-Coordination/Fraud-Prevention/Medicaid-Integrity-Education/Downloads/fwa-laws-resourceguide.pdf

Department of Health and Human Services, Centers for Medicare and Medicaid Services. Medicare Fraud and Abuse. 2016 October. https:// www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/ MLNProducts/downloads/Fraud_and_Abuse.pdf

Department of Health and Human Services, Centers for Medicare and Medicaid Services. Medicare Program: Reporting and Returning of Overpayments; Final Rule. Federal Register 2016, Feb. 12:81(29). https://www.gpo.gov/fdsys/pkg/FR-2016-02-12/pdf/2016-02789.pdf

Huey K. Documenting to support medical necessity. AAPC, October 2012. http://static.aapc.com/a3c7c3fe-6fa1-4d67-8534-a3c9c8315fa0/cfa2b133- ce13-47e1-90c1-4907eba70dbd/6b9dc000-0897-4c24-9f4a-519e1f3ab372.pdf

Jensen PR. A refresher on medical necessity. American Academy of Family Physicians Management, 2006. http://www.aafp.org/fpm/2006/0700/p28.pdf

Maccariella-Hafey P. Understanding the history component of the E/M code

               -Part 1. AHIMA Codewrite. 2014December.

Maccariella-Hafey P. Understanding the history component of the E/M code

               -Part 2. AHIMA Codewrite. 2015

Optum. Evaluation and management coding advisor. 2013; p. 18-28.

US Departmentof Justice. Individual accountability for corporate wrongdoing. 2015, September 9. https://www.justice.gov/dag/file/769036/download
Verhovshek J. 5 key points about the E/M history component. AAPC. 2014, March 3. https://www.aapc.com/blog/26777-5-key-points-about-the-em- history-component/

Free Mini-Course: The Business of Wound Care and Hyperbaric Medicine

Join us for this free 4-part mini-course and jump start your clinic business today! 
  • Are you a clinic manager or medical director who wants to increase patient load and referrals but has no money for marketing?
  • Could you be losing money due to incorrect billing and coding?
  • Do you want to become a profit center for the hospital but inefficient business operations are holding your clinic back?

If you don't know where to start, how to start, or what you need to know to take your clinic to the next level, this free 4-part mini-course is for you.

This mini-course is taught by Dr. Michael White, MD, MMM, CWS, UHM and course director for the live two-day workshop, The Business of Wound Care and Hyperbaric Medicine.

You Will Learn:

Lesson 1: [Video] How to create a strong (or stronger) foundation for your clinic business

  • How to identify where your patient referrals are coming from (or should be coming from).
  • How to create an action plan for effective, efficient marketing.
  • How to become a profit center for the hospital.

Lesson 2: [Video] The explosion of chronic wounds in the U.S. and the opportunity for wound care and hyperbaric medicine clinics to serve more patients.

Lesson 3: 4 Easy steps to market your clinic.

Lesson 4: How key are front office operations to the wound clinic business?

  • Learn the two key considerations for creating efficient front office operations that contribute to the achievement of your clinic's overall financial goals.
Join us for this free 4-part mini-course and jump start your clinic business today! 

SIGN UP HERE 

About the Author

Gretchen-Dixon
GRETCHEN DIXON, MBA, RN, CCS, is the owner of Professional Compliance Strategies (PCS), LLC, and consults on outpatient departments and physician services. She has provided revenue- cycle compliance audits of services with a focus on wound care department operations for more than 10 years. She holds several credentials including an MBA in healthcare management, an RN with a practicing license in New York, and 23 multistate licensure from Virginia, AHIMA Certified Coding Specialist (CCS), AHIMA ICD-10-CM/PCS Approved Trainer, and is an AAPC Certified Professional (Healthcare) Compliance Officer. A longtime internal healthcare auditor, Dixon identifies issues through audits of D, C, B (documentation, coding and billing) of provided services. The outcome of each audit determines the topics of education to be provided to the staff and physicians, as she proactively believes education is the key to having complete, accurate, and consistent documentation supporting reimbursement for billed services. If you are interested in her services, contact Dixon at This email address is being protected from spambots. You need JavaScript enabled to view it. or call 1-615-210-7476.
 

Overutilization of Antibiotics in the Outpatient Wound Care/Hyperbaric Program

  • Laura Josefsen, RN, ACHRN
  • Volume 08 - Issue 2

“If you cannot measure it, you cannot improve it.”

— Lord Kelvin

It is known that antibiotics are necessary and save lives. It is also known that the overutilization and/or inappropriate use of antibiotics may result in drug-resistant bacteria that can lead to complications resulting in less-than-optimal outcomes for the patient as well as in increased costs. The issue of antibiotic overutilization has become a national priority for patient safety by governmental health-care agencies.

Antibiotic stewardship programs (ASPs) are quality- improvement processes to gather data to evaluate and determine evidence-based practice guidelines to better define diagnostic criteria for antibiotic use. These data include the following:

  • Assessing wound

  • Obtaining wound cultures

    • Determine whether wound is colonized or infected.

    • Perform cultures prior to antibiotic use.

    • Ensure wound culture is not contaminated.

  • Monitoring the antibiotics being prescribed

    • Recommend pharmacy oversight.

  • Utilizing antibiotic time-out after 48hours

    • Determine correct antibiotic per culture result(may need specific antibiotic).

    • Determine if wound is multiply infected (may need broad spectrum antibiotic).

    • Determine if modifications are needed.

  • Administering antibiotic medication by nursing staff

    • Education for patient

  • What to expect from medication — drug action and side effects

  • Indications

  • Correct dosage

  • Right of administration

  • Have automatic stop orders in place

  • Monitoring patient compliance

  • Nursing assessment includes the following:

    • Medication list, medication reconciliation

    • Allergies and allergy reconciliation

    • Culture results monitored to ensure antibiotic

    • Change in condition or adverse reaction to antibiotics monitored for patient

  • Ongoing assessment of the patient and the wound

    • Wound healing progress

  • Determine when wound is no longer infected
  • Recommended system for evaluating data:

  • A physician leader

  • Leadership commitment

  • Education

    • Patient education

    • Regular updates on data

    • Transparency of ongoing results with clinical staff

    • Ensuring staffcompetencies

      • Wound cultures
      • Understanding colonization vs.infection
  • Chart reviews — current and retrospectivefor completeness of information above

  • Development of clinical pathways

Patient safety is the primary goal for the process of ASPs. Now is the time to be proactive in developing this process for your unit as data are being  gathered  around  the nation to provide evidence-based practice guidelines for antibiotic use.

Resources

Centers for Disease Control and Prevention. Measuring outpatient antibiotic prescribing. Updated March 22, 2017. Available

at: https://www.cdc.gov/getsmart/community/programs- measurement/measuring-antibiotic-prescribing.html

Centers for Disease Control and Prevention. Outpatient antibiotic prescriptions: United States, 2014. Available at: https://www.cdc.gov/getsmart/community/pdfs/annual- reportsummary_2014.pdf

Drekonja D, Filice G, Greer N, Olson A, Wilt T, MacDonald R, Rutks I. Antimicrobial stewardship programs in outpatient settings: a systematic review. VA-ESP Project #09-009.

Washington, DC: Department of Veterans Affairs; February 2014. Available at: https://www.hsrd.research.va.gov/ publications/esp/antimicrobial-outpatient-EXEC.pdf

Sanchez GV, Fleming-Dutra KE, Roberts RM, Hicks LA. Core elements of outpatient antibiotic stewardship. MMWR Recomm Rep. 2016;65(No. RR-6):1–12. Updated November 10, 2016. Available at: DOI: http://dx.doi.org/10.15585/mmwr. rr6506a1

 

About the Author

Laura-Josefsen

LAURA JOSEFSEN, RN, ACHRN, has been involved in hyperbaric nursing since 1982. A founding member of the Baromedical Nurses Association (BNA) in 1985, she served as BNA president from 1996 to 1998 and as a board member in several positions throughout the years. She served on the Undersea and Hyperbaric Medical Society (UHMS) Associates Council for six years, with two of those years as Nurse Representative on the UHMS Board of Directors. She has been a member of the UHMS Accreditation Team as a nurse surveyor, served for many years as an executive board member of the National Board of Diving and Hyperbaric Medical Technology and is a previous chairman of the BNA Certification Board. She is a member of the UHMS Associates, former member of Divers Alert Network, and former member of the Hyperbaric Technologists and Nurses Association (HTNA) of Australia. She has numerous publications and is an internationally recognized speaker in the field of hyperbaric medicine.

Her passions are quality improvement and education to promote hyperbaric nursing, safety, and optimal standards of care and practice for patients and the community.

 

Protective Footwear

  • Anna M. Tan, Michael B. Strauss, and Lientra Q. Lu
  • Volume 08 - Issue 2

In the previous issue of WCHM, Part 4A in the Diabetic Wound Prevention series provided detailed descriptions of shoe characteristics and sock components along with various types of protective footwear, ranging from quality athletic walking shoes to Charcot restraint orthotic walker (CROW) boots. Now, in Part 4B, we continue to expound on protective footwear as an essential component for the prevention of new and recurrent wounds by addressing some common misconceptions and discussing custom foot orthotics and total contact casting (TCC). In addition, this article details the Medicare “Therapeutic Shoe Bill” and highlights a few challenging situations in which protective footwear may be insufficient and surgery and other interventions may be necessary.

Making Sense of Orthotics

Orthotic considerations. In the previous section, orthotics were mentioned as a prescription item added to off-the-shelf footwear to control alignment of the feet and ankles. Simply stated, orthotics are devices that improve or straighten the alignment of body parts. They can be as simple as a heel pad added to a shoe or as complicated as a total-control lower-extremity brace.

Orthotics play an important role in prescription footwear because deformities are frequently a precursor to foot wounds. Many patients with feet that are at risk for wounds have deformities. The three largest user groups for orthotics are children with foot concerns articulated by their parents, athletes and others who experience foot pain with activities, and patients who have neurological impairments (especially patients with diabetes).

Much confusion exists as to what orthotics do and when they are needed (Figure 9).8 The consequences of this are overutilization, inappropriate applications, and needless expenditures for these devices. The following information discusses seven misconceptions and/or fallacies pertaining to orthotics. The goals are twofold: to make sense out of their use and to delineate their indications for foot conditions at risk for wounds (Table 3). Indications for prescribing and using orthotics are different for those patients with risk factors for developing wounds (deformity, previous amputation, previous wound, peripheral artery disease and/ or neuropathy) versus those using orthotics to manage symptoms that are associated with walking and running.

FIGURE 9. Fallacies and responses regarding

FIGURE-1

Legend: Generalizations about prescribing and using othotics are different for those patients with risk factors for developing wounds versus those using orthotics to manage pain symptoms (usually with activities).

 

A good example of the effective use of an orthotic is in the situation of a shortened limb. The shortening will cause a person to limp and lean to the side when standing unless compensatory measures are done, such as bending the opposite knee or the spine. This puts an extra strain on the muscles and joints that control these body parts and will likely become a source of pain.
The easiest solution is to add a lift to the shoe of the shorter extremity to equalize the extremity lengths. This will correct the alignment and prevent the extra stresses and strains placed on the body parts used to compensate for the limb length discrepancy.
Comment: This exemplifies the principle of using an orthotic. In the case of the foot at risk with deformities, one role of orthotics is to prevent wounds.

 

TABLE 3. Frequently observed foot deformities and their orthotic management

Problems Type/How Manifested* Orthotic Management
Location: Primary the Forefoot

Metatarsus adductus

(In-toeing, adduction)

Planar/Static with dynamic

components

Straight or reverse last shoes

Lateral heel +/- medical sole wedges; pronator pads (all of questionably benefit; usually improves spontaneously with time)

Metatarsus abductus

(Out-toeing—abduction, "skew" foot)

Same as above (SAA) Medial heel and/or lateral sole wedges; pronator pads (all questionably effective)

Toe deformities

(Mallet, hammer, claw, angulated or rotatory)

Most are planar & static with dynamic components Toe separators, lambs wool between toes, shoes with large toe boxes

Forefoot supination

(Inversion)

Non-planar/Static with dynamic components Lateral forefoot wedges for inserts and or soles of shoes; if due to Charcot neuroarthropathy, consider CROW (Charcot restraint orthotic walker) boot

Forefoot pronation

(Eversion)

SAA Medical forefoot and/or sole wedges
Location: Primarily the Midfoot (Arch portion of the foot)

Flatfoot

(Pes planus)

Planar/Dynamic, but accentuated with loading Arch supports; if asymptomatic, leave untreated
Hyperpronation Usually with hindfoot valgus + flat feet Custom molded arch supports with medial heel wedges

Cavus foot

(Abnormally high arches)

Planar/Static Custom molded arch supports supplemented with forefoot and heel pressure relief pads
Congenital vertical talus SAA Custom shoes; generally not manageable with footwear and orthotics; surgery usually required
Location: Primarily the Hindfoot (Heel portion of the foot) and Ankle

Varus heel

(Inward tilting, supination)

Non-planar/Static Lateral heel wedges; frequently in association with forefoot and midfoot supination management

Valgus heel

(Outward tilting, pronation)

SAA Medial heel wedges; usually in conjunction with midfoot hyperpronation management
Equinus contracture Planar, non-planar (with hindfoot varus/Static Heel lifts; Klenzak brace; management of heel varus; Frequently Achilles tendon lengthening required
Location: Combinations (Involvement of 2 or more foot & ankle components)

Clubfoot

(Heel varus, forefoot adduction + ankle equinus)

Non-planar/Static Casting, Achilles tendon lengthening; custom orthotics as needed
Charcot arthropathy SAA The apex of the hierarchy of prescription footwear; see Figures 2 through 8

Zig zag (skewfoot)

(plantar deformities in 2 or more directions)

Planar/Static Custom molded shoes; surgery

Notes: *Type refers to plane of the foot; planar indicates it is flat, while non-planar means it is tilited (e.g. varus vs valgus; pronation vs supination; inversion vs eversion, etc.)

How manifested refers to whether it is Static, that is the deformity is presented when the foot is un-loaded or Dynamic that it occurs with loading, muscle contraction and/or walking.

 

Misconception 1: A minimal discrepancy or deformity — for example, mild flattening of the feet or tilting of the heels — never needs an orthotic.

Fact: The answer to this question is tricky. If the problem causes symptoms—for example, pain, stiffness, soreness, swelling, etc. with activities or signs of irritation of the skin are observed at the deformity site — it should be managed with orthotics (or other offloading techniques). The question is tricky because if the person can do the activity without symptoms, as is often the case in athletes or children, orthotics are not needed. If the foot is at risk for wound formation, however, everything possible, including orthotics (and other offloading measures), should be done to prevent a wound from developing due to the multiplier effect of repetitive sub threshold (i.e., below the severity to generate an acute ulceration, but enough to generate erythema, callus formation and/or pain) stresses.

If a deformity, albeit minor, places extra work on muscles and joints or places extra stresses on the skin, problems from repetitive stresses, such as those that occur with walking, have a multiplier effect.
For example, a problem that requires a muscle to contract only 1/16th of an inch more than normal may have to move an extra 27 1/2 feet with walking a mile (assuming a stride length of 12 inches) than muscles not having to work as hard during the mile walk. In the situation of contact pressures to the skin, 1/16th of an ounce more weight to the skin with each step subjects the skin to more than 300 pounds of summated extra contact pressures over the deformity with the mile walk.

 

Misconception 2: There is little objectivity in deciding what situations require an orthotic.

Fact: Objectivity in prescribing orthotics is afforded by pairing the patient’s symptoms with the following signs:

  • Imbalances refer to alterations in muscle control that lead to abnormal the antagonist muscles’ activities. Diabetes, nerve injuries/spinal cord injuries, strokes, Parkinsonism and hereditary conditions are the most frequent causes of muscle imbalances. With time, contractures arise and joints become permanently deformed.
  • Contractures arise in joints when imbalances persist or joints are positioned in the wrong position for sustained periods, such as with casting. Joint stiffness and decreased range of motion are findings associated with contractures. A joint contracture is defined when the loss of motion becomes fixed — for example, an equinus contracture from shortening of the Achilles (calf) tendon/muscle group. When this occurs, the ankle can no longer be brought to the neutral position.

  • Deformities are structural changes in the anatomy of the foot and ankle such as bunions, Charcot of bone (e.g., spurs, malalignments after fractures, congenital anomalies, collapses associated with Charcot neuroarthropathy, etc.). Many deformities are amenable to management with orthotics as will be described in the third misconception in this section neuroarthropathies, forefoot adductus, hindfoot varus or depressed metatarsal heads (the precursor of forefoot malperforans ulcers). Deformities arise from muscle imbalances as observed with clawing of toes, loss of ligament support, bony overgrowth from repetitive pressure/shearing stresses, structural abnormalities, collapses associated with Charcot neuroarthropathy, etc.). Many deformities are amenable to management with orthotics as will be described in the third misconception in this section.

When orthotic selection is addressed from these three perspectives, logical decisions become obvious. When sensation is absent, as is so frequently observed in patients with problem wounds, the decision for orthotic selection is made from the above signs. When these problems are not manageable by orthotics, then surgical interventions, many of which are minimally invasive and can be done in the office setting are needed. This is in contrast to athletes where pain symptoms are the indication for obtaining orthotics.

Misconception 3: So many deformities can occur in the foot and/or ankle that it is difficult to make decisions as to what orthotic is appropriate.

Fact: Although more than a dozen deformities may be ascribed to the foot, they can be readily understood if considered from the following elements (Table 3): 1) location (forefoot including toes, midfoot, hindfoot or combinations), 2) type (such as primarily a) planar — the foot remains flat such as with abduction, adduction and equinus) or b) nonplanar — the normal flat surface of the foot is tilted as observed in hyperpronation-eversion- valgus or supination-inversion-varus deformities), and 3) how manifested (dynamic implies that the problem occurs with activity whereas static means the problem is fixed and present whether at rest or with activity). Each problem may be due to a single element or compound — that is, consisting of two or more of the above elements.

From the above information, some terms refer to specific locations, while other terms overlap. Varus and valgus type deformities imply a single location such as the heel, forefoot or ankle. Pronation type deformities are generally ascribed to the midfoot. Often hindfoot valgus occurs in association with midfoot pronation. Abduction and adduction deformities are used to describe forefoot abnormalities. External and internal rotations refer to the foot position with respect to the leg.
Supination, eversion, and inversion are terms implying involvement of the entire foot.
Static manifestations refer to the deformity being present without loading. Dynamic deformities become apparent with muscle activity, loading and movement. In general, dynamic deformities in nonneurologically impaired individuals do not require orthotics when they are present in the absence of pain.
In contrast, dynamic deformities in the patients with neuropathies require interventions, initially with protective footwear and, if not successful, surgery. This is because this latter group of patients is prone to develop pressure ulcerations from their deformities with activity, but not recognize them until the wounds have already occurred.

Misconception 4: Foot deformities invariably worsen with time; hence orthotics should be used as soon as a problem is recognized.

Fact: Judgment is essential for making decisions about when to prescribe orthotics. The majority of foot deformities in children such as in- toeing, flat feet, and toe walking resolve spontaneously as the child matures. In the presence of neurological impairments (e.g., cerebral palsy, myelodysplasia, polio, etc.), spontaneous correction is not likely to occur. Orthotics and/or surgical interventions should be utilized early to prevent worsening deformities.

For adults with asymptomatic, nonprogressing deformities, orthotics are not indicated. For adults who develop new deformities such as hyperpronation of the midfoot (e.g., secondary to posterior tibial tendon dysfunction), especially those with risk factors for developing foot wounds, orthotics and protective footwear are indicated as soon as the problem is recognized. The goals are to prevent the deformity from progressing and/or the development of wounds that could require surgery in the future.

Misconception 5: Shoe comfort and wear patterns are nonreliable indicators of the need for orthotics.

Fact: Shoe comfort and wear patterns provide important clues for decision making about orthotic selection. In the normal foot, shoe wear is first noted along the lateral edge of the heel and the center portion of the toeward end of the sole. As the shoe wears, the upper materials may stretch to accommodate a deformity, and in the absence of sensation, the patient may not complain of pain in the shoe as it is stretched out.

Lambswool is a very effective padding/offloading device. Ballet dancers use lambswool to protect their toes en pointe (i.e., toe dancing) because it does not compress and it concentrates forces as pressure is applied to it. Additionally, it does not lose its form and function from moisture. For these reasons, patients with pre-ulcerative lesions on their toes or in need of filler for missing toe parts, can use lambswool as an effective, inexpensive toe separator or pressure distributor and/or filler in their shoes.
Like other fabric materials, it will become soiled with use and retain odors, so the lambswool padding must be changed on an as-needed basis when these conditions are observed.

Obviously pressure areas are deforming the shoe and can evolve to ulcerations at the deformity site. If the shoe is uncomfortable, explanations are needed and proper adjustments made. Shoe- wear patterns also provide helpful information. For example, if the upper, medial portion of the sole of the shoe has excessive wear, pronation (eversion) is usually the explanation. Excessive medial heel shoe wear indicates excessive hindfoot valgus. These problems need to be recognized and managed with orthotics if the patient has risk factors for developing foot and ankle wounds and/or the deformities are a source of pain.

Misconception 6: If orthotics are indicated, they need to be customized.

Fact: Many conditions for which orthotics are indicated can be managed by simple corrections such as adding a padded insert, an off-the-shelf metatarsal pad, a heel pad, a toe separator, a donut pad or similar devices.9 Many of the padded inserts have additional features such as padding to counteract pronation and gel inserts to provide extra heel or forefoot padding. The off-the- shelf devices usually cost a fraction of custom-molded orthotics. If they relieve symptoms and offload pressure areas, more costly customized orthotics are not indicated. Two guidelines are recommended for prescribing custom- molded orthotics: First, in patients with normal foot sensation, they should be obtained after a trial of less-expensive off-the-shelf versions have been tried, but the off-the-shelf choices provide only partial or no relief of symptoms. Second, in patients with sensory neuropathy and associated deformities, prescription orthotics and footwear are usually indicated even without a trial of off-the-shelf devices.

Misconception 7: If orthotics are obtained, they need to be utilized 100 percent of the time with footwear.

Fact: For patients with normal sensation, orthotics may need to be used only for repetitive stress activities such as running. Running activities  multiply and replicate the stresses through the feet more than three times the person’s body weight, somewhat analogous to driving a nail into a board. If symptoms are not noted with standing or walking, orthotics need not be used for these activities. In patients subject to foot or ankle ulcerations because of sensory neuropathy or other risk factors for wounds, the orthotic is used to prevent a wound from occurring and consequently should be utilized with all standing and walking activity.

The driving the nail into a board analogy is good one when considering what happens with repetitive multiplier forces. The hammer merely resting on the nail will not drive the nail into the board. Wth each strike, however, the force of the hammer head is multiplied manyfold (i.e., its kinetic energy) thereby driving the nail into the board.
Clinical correlations: A 38-year-old healthy male began to experience unilateral left midcalf pain during running activities. Typically, symptoms did not occur until 5 miles into a 7- to 10-mile run. Although concern was raised that the patient may have a chronic exertional compartment syndrome, examination demonstrated a hypermobile left forefoot, and his symptoms were attributed to a chronic, overuse calf muscle strain with running activities.
The insertion of a quarter-inch heel lift into his running shoes eliminated his pain symptoms with long runs. The lift was not used for regular walking activities.
Comment: By reducing the excursion of the left calf muscles with the quarter- inch heel lift, the summated repetitive forces to the calf muscle were substantially reduced over a 7-mile run (quarter inch less excursion with each step • multiplied by the patient’s 180-pound body weight • multiplied threefold with stance phase loading • times 2,000-foot stance phase loadings — assuming a 3-foot running stride — for each mile • times 7 miles summates to more than a million foot pounds force reduction for the left calf muscles with the lift during the run).

Prescribing Orthotics

In summary, the decision to prescribe orthotics should be based on the patient’s complaints, the problems (e.g., muscle imbalances, contractures or deformities) found during the exam and what is the most  cost-effective way of managing it. For patients with normal sensation, many orthotic requirements can be met with off-the- shelf devices. Custom-made orthotics should be prescribed by physicians familiar with the evaluation, management and prevention of foot and ankle problems and obtained through pedorthotists and podiatrists familiar with the options and available applications. In patients with neurological impairments, associated deformities and the other risk factors for foot and ankle wound occurrence, custom-prescribed orthotics and protective footwear are advised because this is the at-risk group for developing problems.

Total Contact Casting (TCC)

Although total contact casts (TCC) have been considered the gold standard for offloading, recurrence rates with TCC after healing and compliant use of protective footwear approach 50 percent.10 TCC is often recommended for outpatient management of diabetic foot ulcers, especially in forefoot locations; these ulcers, however, typically occur because of underlying deformities. When the ulcers occur in the midfoot and hindfoot, and especially if hospital management is required to manage the deformity, TCC is usually not sufficient and surgery is required.

Historically, there is an extremely low use rate by clinicians and poor patient tolerance due to logistical purposes. First, the cast usually must be removed if the provider wants to examine or treat the wound; and the process of placing the TCC is quite time-consuming (Table 4). Second, it is not recommended for patients with underlying bony infection, deep sinus tracts, large draining wounds, dermatitis, excessive edema, severe peripheral arterial insufficiency, and "cast claustrophobia."

TABLE 4. Total contact casting application

TABLE-4

Inappropriate Use of Protective Footwear

In some situations, protective footwear will not provide adequate offloading. The wound care provider must appreciate this and not persist with new and/or alterations of the patient’s protective footwear in hopes of achieving a solution while the wound deteriorates and/or recurs. In such situations surgery and other interventions become necessary. In many situations, the causes are multifactorial, and the solutions require more than one intervention. In almost all cases after interventions, properly prescribed protective footwear is required. Consider the following challenges and their solutions:

1. Challenge: Progressively worsening deformity such as a subluxing ankle joint with increasing angulation and impending breakdown of skin over the apex (e.g., the lateral malleolus) of the deformity (Figure 10) Solution: Osteotomy to realign ankle and intramedullary ankle rodding or temporary external fixation with the ankle in the reduced position. Extremity shortening secondary to the osteotomy should be equalized with shoe lifts.

FIGURE 10. Deformity where protective footwear becomes inadequate

FIGURE-10

Legend: Severe deformity with infected lateral malleolus exceeds the ability of a CROW boot or total contact casting to manage. Surgical realignment or below knee amputation become the options.

 

2. Challenge: Protruding bone or bony prominence at the base of an ulcer that has not improved with offloading Solution: Exploration and debridement of bony prominence (i.e. ostectomy), reactive bursa and cicatrix formation surrounding the deformity.

3. Challenge: Recurrences of a malperforans ulcer under a metatarsal head after healing with total contact casting and use of protective footwear Solution: Realignment of metatarsal head with simple percutaneous scoring of the metatarsal at the neck level and osteoclasis to direct the metatarsal head dorsally. A Weil osteotomy is also an option but is more invasive and requires internal fixation.

4. Challenge: Hindfoot ulcer with loss of heel foot pad and boney prominence in base of wound without an ankle dorsiflexion contracture (i.e., muscle imbalance with loss of gastrosoleus muscle strength) Solution: Partial calcanectomy with ankle fusion or release of ankle dorsiflexors

5. Challenge: Flail midfoot with severe destruction of midfoot bones secondary to Charcot neuroarthropathy Solution: Resect nonfunctional midfoot bones to shorten foot length with or without bone grafting

6. Challenge: Claudication with rest pain regardless of footwear Solution: Lower-limb

7. Challenge: Severe equinus contracture with plantar surface pressure sores at the tips of the toes Solution: Achilles tendon lengthening

8. Challenge: Morbid obesity and/or massive lymphedema Solution: Edema control, weight reduction including surgical techniques, wheelchair ambulation

9. Challenge: Dry, scaly atrophic plantar forefoot and heel fat pads Solution: Daily skin cleansing and lubrication; optimal shoe padding and fit.

10. Challenge: Abnormal, excessive shear forces with walking secondary to muscle imbalances, weaknesses or deficiencies secondary to neurological conditions or trauma Solution: Physical therapy and gait training; orthotics to mitigate deformities; walking aids from cane to motorized wheelchair.

In some situations, ambulation needs to be restricted or almost totally avoided to prevent new or recurrent foot wounds regardless of the interventions. Fortunately, other options for mobility exist, such as wheelchairs and motorized scooters/wheelchairs. When such assistive devices are prescribed, it should not be considered a failure of protective footwear or management but rather insight to the total needs of the patient.

Medicare Therapeutic Footwear Benefits

Therapeutic Shoe Bill. It is no coincidence that Medicare (Center for Medicare/Medicaid Services) provides funding for diabetic footwear. In 1993 the Therapeutic Shoe Bill (TSB) benefit became a Medicare entitlement for diabetic patients.11 This policy exemplifies the goals of preventative medicine. It provides a mechanism for diabetic patients with risk factors for developing foot wounds to obtain protective footwear. Most significantly, this benefit is proactive (in contrast to many of the other Medicare entitlements), as it provides a means to prevent a problem from occurring rather than the much more expensive alternative of treating it after it has already arisen.

This entitlement provides tangible benefits with protective footwear rather than only education, as in smoking-prevention, need for exercise and weight-reduction programs.

Stipulations of the Therapeutic Shoe Bill.

The TSB benefit has several stipulations: First, the beneficiary must have Medicare Part-B (physician services) coverage. Second, a signed certificate of medical necessity (CMN) is needed from the prescribing physician that therapeutic footwear is required; the CMN should include the following four affidavits:

  • The patient has diabetes mellitus
  • The patient has one or more of the following conditions involving either foot:

             —history of partial or complete amputation of the foot

             —history of previous foot ulceration

             —history of preulcerative callus

             —peripheral neuropathy with evidence of callus

             —foot deformity

             —poor circulation

  • The prescribing physician is treating the patient under a comprehensive plan of care for his/her diabetes

  • The patient needs special shoes (extra depth orcustom-molded shoes), inserts or modifications because of his/her diabetes

Third, the prescription for therapeutic footwear is written by a qualified physician, that is someone knowledgeable about protective footwear and inserts. Finally, the therapeutic footwear must be supplied by a pedorthotist, other qualified individual, or a retail store that sells footwear approved by the TSB.

Replacements and costs. Medicare therapeutic footwear benefits are provided yearly. In a given calendar year, Medicare will cover 80% of the allowed amounts for one of the following:

  • One pair of off-the-shelf extra-depth shoes plus three pairs of multidensity inserts
  • One pair of off-the-shelf extra-depth shoes including modifications (such as fillers, lifts, wedges, relief for pressure areas, etc.) plus two pairs of multidensity inserts
  • One pair of custom-molded shoes plus two pairs of multidensity inserts each year

It is important to note that the TSB is not a program intended to provide shoes for all diabetics, but its primary goal is to prevent ulcerations/ amputations in the at-risk patient.

This means that the patient or the patient’s secondary insurance is responsible for paying the remaining 20 percent of the bill at the time the shoes and/or inserts are dispensed if the supplier accepts Medicare assignment. If not, the patient needs to pay the supplier and submit the paper work directly to Medicare for reimbursement.

By the footwear/insert provider accepting assignment, it is understood that the charges for the protective footwear will conform to what Medicare considers reasonable and customary.

Alternatives to the Therapeutic Shoe Bill. Although the Medicare TSB applies specifically to diabetic patients, are there other alternatives for patients with problem wounds or risk factors for developing problem wounds who do not have Medicare Part-B benefits? The answer is a somewhat qualified yes. Many state Medicaid programs have provisions that parallel the Medicare guidelines. Private insurance companies may or may not have provisions for protective footwear. If the footwear is indicated, however, a “letter of petition” by the prescribing physician to the insurance carrier describing the problem and the justification and the predicted cost-benefits for protective footwear is often sufficient to reimbursement for the footwear. A third alternative is for the patient to pay for the protective footwear/inserts himself/herself. Many times, charges for similar items vary considerably from one supplier to another and/or discounts are given for paying cash.

A  clinical correlations: A 25-year-old male metal worker sustains a crush injury to his left foot when a 1,000-pound plate falls on his foot, necessitating a modified (the lateral two rays removed to the level of the cuboid) transmetatarsal amputation.
Although his insurance benefits provide a prosthesis for a below-knee amputation, they specifically exclude providing off-the-shelf shoes with modifications.
A “letter of petition” was submitted to the insurance company explaining the necessity for protective footwear for the patient. The letter included three major arguments. First, without the prescribed protective footwear, the patient was at risk of developing new problems that could result in costly hospitalizations and an even higher-level amputation. Second, with the prescription footwear, there would be
a high likelihood that the patient could return to his previous level of work without restrictions. Third, other insurance providers, including Medicare, have provisions to address this problem.
With the “letter of petition,” the request for protective footwear was approved for the patient.
Comment: Insurance carriers are more likely to respond to out-of-network benefits when the benefit is cost-beneficial, allows the patient to return to his/her usual and customary activities and is a provided by Medicare or other third-party carriers.

For nonwound prevention considerations, such as pain relief with running, the patient may have to pay for the custom orthotics out of pocket. Finally, less costly alternatives such as using lambswool for fillers and toe separators, off-the-shelf inserts, shoes with built-in pronation inserts, casts, etc., can be used as an interim measure when it is not possible to obtain custom protective footwear.

Do’s and Don’ts Pertaining to Protective Footwear

Do’s with respect to protective footwear:

  • Wear appropriate footwear for your foot and ankle problems.

  • Frequently check shoes and orthotics for signs of wear poor fit.

Don’ts to prevent new or recurrent foot wounds

  • Don’t walk barefooted (use protective footwear at all times when out of bed).

  • Don't assume a new pair of shoes, even if provided from a footwear prescription, will fit perfectly. “Break them in” slowly, initially wearing the shoes for only for a few minutes at a time and then removing them to inspect the skin for pressure areas or signs of rubbing.

  • Don’t wear inappropriate shoes for fashion reasons or because they feel comfortable (such as house shoes and slippers without appropriate support).

Conclusions

The selection of protective footwear is both an art and a science. The science is reflected by the wealth of information available about the components of footwear, the variety of choices available for protective footwear and orthotics and the ability to confirm by examination and imaging studies what the structural problems are. The selection of protective footwear is also an art. Decisions have to be made as to what level of the protective footwear hierarchy is appropriate for the patient. Foot and ankle problems are frequently unique and require individual modifications for the shoe. Foot problems change, so what is appropriate initially may require alterations in the future.

It is obvious that “If the shoe fits, don’t always wear it.” This has several implications. First, patients may prefer to wear their old, worn, deformed shoes because they feel so comfortable instead of their new or replacement footwear.

Second, newly prescribed footwear often requires modifications to fit properly. The more complicated the problem, the more likely modifications will be required. In our experiences, about 50 percent of the footwear prescriptions we write require additional modifications by the pedorthotist or certified footwear provider as the patient begins to use the footwear.

Third, there may be delays in patients’ appreciation of new foot and ankle problems with their new footwear due to sensory neuropathy. Fourth, patients with risk factors for developing foot and ankle wounds often have ongoing, progressively worsening deformities, peripheral artery disease and neuropathy. The changes associated with these may require expedient revisions in footwear and/or surgical interventions.

Listen to the patients, and hear what they like about their old shoes and what they do not like about their new protective footwear. Then pair this information with the science that is needed to meet their prescription footwear needs. As stated previously, protective footwear is the second line of defense (after skin and toenail care) for preventing problems in patients with risk factors for foot and ankle wound formation. If protective footwear is appropriately prescribed and the patient is instructed in the philosophy behind the quotation “If the shoe fits, don’t always wear it,” new wound problems can usually be prevented. When protective footwear cannot accomplish these goals, then surgery, the first line of offense, may be required.

 

References

1. Cavanagh PR, Owings TM. Nonsurgical strategies for healing and preventing recurrence of diabetic foot ulcers. Foot Ankle Clin. 2006; 11(4):735-743.

2. Strauss MB, Miller SS. Diabetic Foot Problems: Keys to effective, Aggressive Prevention. Consultant 2007; March: 245-25.

3. Sugarman JR, Reiber GE, Baumgardner G, et al. Use of the therapeutic footwear benefit among diabetic Medicare beneficiaries in three states. Diabetes Care. 1998; 21:777-781.

4. Wooldridge J, Moreno L. Evaluation of the costs to Medicare of covering therapeutic shoes for diabetic patients. DiabetesCare. 1994; 17:541-547.

5. Paton J, Jones RB, Stenhouse E, Bruce G. The physical characteristics of materials used in the manufacture of orthoses for patients with diabetes. Foot Ankle Int. 2007: 28(10):1057-1063.

6. Hastings MK, Mueller MJ, Pilgram TK, et al. Effect of metatarsal pad placement on plantar pressure in people with diabetes mellitus and peripheral neuropathy. Foot Ankle Int. 2007; 28(1):84-88.

7. Brown D, Wertsch JJ, Harris GF, et al. Effect of rocker soles on plantar pressures. Arch Phys Med Rehabil. 2004; 85(1):81-86.

8. Janisse DJ, Janisse E. Shoe modification and the use of orthoses in the treatment of and ankle pathology. J Am Acad Orthop Surg. 2008; 16(3):152-158.

9. Groner C. Orthosis Symbiosis: Clinicians are finding a middle ground in the debate over custom versus prefab foot orthoses. BioMechanics. 2005, 12(5):22-23.

10. Frigg A, Pagenstert G, Schafer D, et al. Recurrence and prevention of diabetic foot ulcers and total contact casting. Foot Ankle Int. 2007 Jan; 28(1):64-69.

11. Janissee DJ. The Therapeutic Shoe Bill: Medicare coverage for prescription footwear for diabetic patients. Foot Ankle Int. 2005; 26(1):42-45.

About the Authors

MICHAEL-STRAUSS-MD

MICHAEL STRAUSS, M.D., an orthopaedic surgeon, is the retired medical director of the Hyperbaric Medicine Program at Long Beach Memorial Medical Center in Long Beach, California. He continues to be clinically active in the program and focuses his orthopaedic surgical practice on evaluation, management and prevention of challenging wounds. Dr. Strauss is a clinical professor of orthopaedic surgery at the University of California, Irvine, and the orthopaedic consultant for the Prevention- Amputation Veterans Everywhere (PAVE) Problem Wound Clinic at the VA Medical Center in Long Beach. He is well known to readers of WCHM from his multiple articles related to wounds and diving medicine published in previous editions of the journal. In addition, he has authored two highly acclaimed texts, Diving Science and MasterMinding Wounds. Dr. Strauss is actively studying the reliability and validity of the innovative, user-friendly Long Beach Wound Score, for which he already has authored a number of publications.

 

ANNA-M-TAN-DPM

ANNA M. TAN, DPM, is the chief resident of podiatric medicine and surgery at Long Beach Memorial Medical Center. She graduated cum laude from the University of Southern California in 2006 and received the Dean’s Award for her undergraduate research on netrin-1, a protein involved in axonal guidance. Subsequently, she attended the California School of Podiatric Medicine at Samuel Merritt University in Oakland, California, receiving her doctor of podiatric medicine degree in 2014. Dr. Tan has special interests in surgical management of problem wounds and limb salvage. In her spare time, she enjoys Bikram yoga, cooking and traveling.

 


LIENTRA-LU

LIENTRA LU is a research coordinator at the VA Medical Center in Long Beach, California, under the guidance of Dr. Ian Gordon, a vascular surgeon, and Dr. Michael Strauss. She is also an administrative assistant in the accounting department of the Southern California Institute for Research and Education (SCIRE). She received a bachelor of science degree in chemical biology at the University of California, Berkeley, in 2015 and subsequently has taken medically related courses at the University of California, Los Angeles. Miss Lu is helping with diabetic foot and venous leg ulcer studies at the VA Medical Center while also serving as an assistant in patient care at the PAVE Clinic there. She also works with the American Red Cross in her other interest, disaster preparedness.

 

 

Oxygen and the Brain

  • Philip B. James, MB, ChB, DIH, PhD, FFOM
  • Volume 08 - Issue 2

Few people would dispute that the brain needs oxygen. Oxygen and the Brain, now released by Best Publishing Company for global distribution through Ingram, reinforces its importance.oxygen-and-the-brain

It gives long-overdue recognition of the brilliant Scottish scientist John Scott Haldane, who pioneered many of the discoveries that today we take for granted. For example, Haldane showed that, curiously, it is carbon dioxide, not lack of oxygen, that drives breathing: A sudden reduction of oxygen level, in fact, increases cardiac output and blood flow, not breathing. He also advocated giving oxygen as a treatment, not simply as a supplement.1

Oxygen is probably the most widely prescribed agent in medical practice, but it is only to ensure “saturation” of the oxygen reservoir hemoglobin: in other words, to ensure that blood is as red as possible.² The book points out that blood oxygen levels can be normal when a patient has a heart attack or a stroke because of a reduction of blood flow in an artery and because cells may die of lack of oxygen, which is called anoxia. The pathology caused by lack of oxygen extends well beyond the volume where cells die because of the localized tissue swelling known as edema.

Oxygen is poorly soluble in water. Cells in this zone are short of oxygen — not dead, but sleeping. Loss of function may be due to the death of cells or simply due to lack of sufficient oxygen to maintain their normal activity, a condition known as hypoxia (hypo meaning below and oxia obviously is oxygen). oxygen-and-the-brain-quote

These two states are widely separated in the brain but cannot be differentiated on clinical examination. The objective of using a high level of oxygen as a treatment, that is, “hyperoxia” — usually delivered in a room at increased pressure known as a hyperbaric chamber — is to allow cells to recover function from an inactive state.

The highlight of the book is an account of the astonishing research showing that oxygen actually controls our most important genes. Beginning with the creation of blood vessels in the embryo, a mechanism that continues throughout life in healing wounds³ from skin to the brain. It ranks in importance with the determination of the structure of DNA.

Research into the effects of lack of oxygen is beginning to be featured in prestigious journals, such as the New England Journal of Medicine (NEJM). A nine-page review in the NEJM in 2011 highlighted the close relationship between cellular hypoxia and inflammation,4 and the latest review published in the journal on May 18, 2017, details the physiological effects of chronic hypoxia.5 The author advocates oxygen conditioning of rooms at altitude by pumping oxygen in from an atmospheric oxygen concentrator, comparing it with air conditioning, suggesting it would improve boardroom decisions.

Tissue hypoxia affects us whenever we are ill or injured. Higher levels of oxygen are needed in treatment, especially for injuries and disease of the brain. It is the next frontier for mainstream medicine.

  1. Haldane JS. The therapeutic administration of oxygen. Br Med J. 1917; i:181-183.
  2. British Thoracic Society guideline for emergency oxygen use in adult patients. Thorax. 2008; 63:Supplement VI.
  3. Semenza G. Oxygen sensing homeostasis and disease. N Eng J Med 2011; 365:537-47.
  4. Eltzschig HK, Carmeliet P. Hypoxia and inflammation. N Eng J Med 2011;364:656-64.
  5. West JB. Physiological effects of chronic hypoxia. N Eng J Med. 376:1965-71.
  6. Burman F, Sheffield R, Posey K. Decision process to assess medical equipment for hyperbaric use. Undersea Hyperb Med. 2009; May-Apr;36(2):137-44.

 

About the Author

PHILIP-B-JAMES-MB-CHB-DIH

PHILIP B. JAMES, MB, CHB, DIH, PHD, FFOM, is emeritus professor of medicine at the University of Dundee. He qualified in medicine from Liverpool Medical School, and after a fellowship in surgical research he studied industrial medicine in Dundee, Scotland. After Royal Navy training, he specialized in diving medicine, combining an academic post in the University of Dundee with consultancies to many international diving contractors, including IUC, Oceaneering, Comex, and Ocean Technical Services.

In 1983 he received the Craig Hoffman Award from the Undersea and Hyperbaric Medical Society for diver paramedic training and contributions to diving safety, including minimum oxygen content in helium, high oxygen partial pressures in divers’ emergency supplies, and the use of helium/oxygen mixtures in recompression treatment. Dr. James also holds a US patent for a cabin membrane oxygen enrichment system for commercial aircraft.

In 1982 he published evidence for subacute fat embolism as a cause of multiple sclerosis in the Lancet, comparing the pathology to decompression sickness and endorsing the use of hyperbaric oxygen treatment. Later studies with Professor Brian A. Hills at the University of Texas in Houston showed that microemboli disturb the blood-brain barrier. Further research in Dundee demonstrated that inflammation, the hallmark of multiple sclerosis (MS), may produce profound tissue oxygen deficiency.

Five MS patients treated by Dr. James in 1981 founded a community hyperbaric facility in Dundee, and there are now 65 charity centers operating in the UK and the Republic of Ireland that provide low-cost hyperbaric oxygen treatment for neurological conditions. The centers were deregulated by Act of Parliament in 2008. Dr. James retired in the same year, but he continues as honorary adviser to the charity, as a consultant to the offshore oil and gas industry, and a passionate advocate for using oxygen in treating disorders of the brain

 

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