VA Schedules 2 Million Appointments Using Veterans Choice Program

Improvements made in increasing access to Community Care, but more work to be done

WASHINGTON – The Department of Veterans Affairs’ (VA) Veterans Choice Program (VCP) has reached a key milestone in improving access to health care for Veterans. More than two million appointments have been scheduled through the program.

“While two million appointments have been scheduled using the Choice Program and we are making progress, we will not rest until all Veterans who choose VA to be their healthcare provider are receiving the care they need, when they need it,” said VA Secretary Robert McDonald.  “We will continue to make strides towards an integrated care network, and I urge Congress to enact our Plan to Consolidate Community Care so we can continue to build upon our progress.”

The Choice Act, which included the VCP, was passed in August 2014 to help Veterans access timely health care both within VA and the community. VA was required to implement a new, national program in just 90 days, with new requirements that complicated the way VA provides community care. VA recognized many of these challenges very early in the implementation of the program and VA and all our stakeholders have been working together to make needed changes while implementing this new nationwide program.

VA has outlined a path to improve community care and create a program that is easy to understand, simple to administer, and meets the needs of Veterans, community providers, and VA staff. VA submitted this plan to Congress in October 2015.

Within the Plan are several legislative proposals that VA and Congress need to work on together to improve the experiences for Veterans and community providers.

  • The first proposal would increase Veterans’ access to community care providers by allowing VA to enter into agreements with local community providers.
  • The second would streamline when and how much VA pays for health care services by having VA be the primary payer.
  • The third fix would allow VA to more accurately account for healthcare purchased in the community.
  • Finally, the last request is for funding and funding flexibility to improve access to care, reimburse the cost of emergency treatment, and create value-based payment models to best serve Veterans that need community care.

“VA is developing innovative ideas and solutions to enhance the Veterans experience and strengthen partnerships with community providers” said Dr. Baligh Yehia, Assistant Deputy Undersecretary for Health, Community Care.  “The Choice Program of today is a very different program than the one rolled out in November 2014. Many improvements have been made and we continue to work to deliver care to Veterans where and when they need it.”

VCP PROGRESS TO DATE

  • Over 2 million appointments scheduled using the VCP significantly increases Veterans access to care.
  • Since the start of VCP we have seen a dramatic increase in utilization.  From October 2015 to March 2016 VCP authorizations for care have increased 103 percent.
  • Over the course of the last 12 months, the Choice Provider Network has grown by 85 percent. The network now has over 350,000 providers and facilities.
  • Improved timeliness of payments to community providers by removing the requirement that VA receive the Veteran’s entire medical record prior to payment.
  • Reduced administrative burden for medical record submission for community providers by streamlining the documentation required.
  • To enhance care coordination for Veterans, we have embedded contractor staff with VA staff at select locations.
  • Created dedicated teams from across the county to deliver community care improvements.
  • VA has also partnered with Congress to change laws to improve the community care experience by:
    • Removing the enrollment date requirement for Choice, allowing more Veterans to receive community care.
    • Implementing criteria of 40-mile driving distance from medical facility with primary care physician to increase number of Veterans accessing the program
    • Implementing the unusual or excessive burden criteria to increase access for Veterans that do not meet other eligibility criteria.
    • Expanding the episode of care authorization from 60 days to up to one year to reduce the administrative burdens of Veterans, community providers, and VA staff.

 “VA needs Congress’s continued support to keep driving progress forward,” added VA Secretary Robert McDonald. “Several legislative barriers remain which inhibit improvements outlined in ourPlan to Consolidate Community Care Programs.

FDA Approves First MRI-Guided Focused Ultrasound Device to Treat Essential Tremor

The U.S. Food and Drug Administration today approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro uses magnetic resonance (MR) images taken during the procedure to deliver focused ultrasound to destroy brain tissue in a tiny area thought to be responsible for causing tremors.

“Patients with essential tremor who have not seen improvement with medication now have a new treatment option that could help them to avoid more invasive surgical treatments,” said Carlos Peña, Ph.D., M.S., director of the division of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health. “As with other treatments for essential tremor, this new device is not a cure but could help patients enjoy a better quality of life.”

Essential tremor, also called benign essential tremor, is the most common form of tremor. According to the National Institute of Neurological Disorders and Stroke, several million Americans, usually those over age 40, are affected by the condition. Essential tremor may be treated with beta blockers or anticonvulsant drugs. If medications fail to control symptoms, the condition may also be treated with surgery (thalamotomy) or a deep brain stimulation device to destroy the tiny part of the brain (thalamus) that controls some involuntary movements.

To determine if the ExAblate Neuro treatment is appropriate, patients should first have MR and computerized tomography (CT) scans. Those undergoing treatment with the MRI-guided device lie in an MRI scanner that takes images to help a doctor identify the targeted area in the brain’s thalamus for treatment. Treatment with transcranial focused ultrasound energy is administered with incremental increases in energy until patients achieve a reduction of tremor. Patients are awake and responsive during the entire treatment.

Data supporting the safety and effectiveness of the device system included a double-blind control trial involving 76 patients with essential tremor who had not responded to medication therapy. Fifty-six of the patients were randomly selected to receive the ExAblate Neuro treatment and 20 received a fake treatment. Patients in the control group were able to cross over into the treatment group three months later.

Patients treated with the ExAblate Neuro showed nearly a 50 percent improvement in their tremors and motor function (composite tremor/motor function score) three months after treatment compared to their baseline score. Patients in the control group had no improvement, and some experienced a slight worsening after the sham procedure before they crossed over into the treatment group. At 12 months post-procedure, the treatment group retained a 40 percent improvement in these scores compared to baseline.

Adverse events for the ExAblate Neuro are consistent with those reported for thalamotomy surgery, including numbness/tingling of the fingers, headache, imbalance/unsteadiness, loss of control of body movements (ataxia) or gait disturbance. Other side effects identified as possibly related to treatment with MR-guided focused ultrasound treatments include tissue damage in an area other than the treatment area, hemorrhage in the treated area requiring emergency treatment, skin burns with ulceration of the skin, skin retraction and scar formation and blood clots.

The ExAblate Neuro treatment is contraindicated for patients who cannot have MR imaging, including those who have a non-MRI compatible implanted metallic device, such as a cardiac pacemaker, those with allergies to MR contrast agents or those with body size limitations for MR.

The treatment should also not be used in women who are pregnant, patients with advanced kidney disease or on dialysis, those with unstable heart conditions or severe hypertension, patients exhibiting any behavior consistent with ethanol or substance abuse or patients with a history of abnormal bleeding, hemorrhage and/or blood clotting disorders (coagulopathy). Patients currently taking anticoagulant drugs or drugs known to increase the risk of hemorrhage, patients with a history of cerebrovascular disease (strokes) or brain tumors and patients who are not able to tolerate the prolonged stationary position during treatment also should not have the procedure.

ExAblate Neuro is manufactured by InSightec in Dallas, Texas.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Hepatitis A Identified In Custer Food Handler

PIERRE, S.D.  July 8, 2016 – A case of hepatitis A has been reported in a food handler at the Pizza Works restaurant in Custer. The food handler worked shifts between June 19 and July 5. Individuals who ate at the restaurant during that time period should contact their health care provider to determine if they need a shot of immune globulin which minimizes their chances of becoming ill or if they should be considered for vaccination.

Pizza Works is cooperating with the department on the investigation.

Hepatitis A is a liver disease caused by a virus. The virus can be carried on an infected person’s hands and can be spread by direct contact, or by consuming food or drink that has been handled by the individual.

Symptoms may include fatigue, poor appetite, fever, abdominal discomfort, and vomiting. Urine may become darker, and then jaundice (a yellowing of the skin and eyes) may appear. The disease is rarely fatal and most people recover in a few weeks without any complications. Infants and young children tend to have very mild symptoms and are less likely to develop jaundice than are older children and adults. Not everyone who is infected will have all of the symptoms.

The single most effective way to prevent the spread of hepatitis A is careful hand-washing after using the toilet. Also, infected people should not handle foods during the contagious period, which begins two weeks before symptoms appear and extends a few days after jaundice appears.

Find more information about hepatitis A at http://doh.sd.gov/diseases

Better Days

 

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Better Days

Peg Ryan
Mile High Pilates and Yoga

Every day is different. Even people living a completely ritualized existence will need to acknowledge this fact.  If nothing else, think about weather.  There may be places on earth where the weather is the same every day, but I doubt it.  Even if you live alone in the woods you are still part of an ecosystem that is in a constant state of flux. None of us is exempt from external influences.  We are all interconnected in this way.  Each of us is just a small part of a larger whole where we frequently find ourselves being impacted by circumstances beyond our control. This can be a blessing or a curse depending on your point of view.

Some of us welcome change.  These folks are constantly seeking something different and may even get bored or restless when things seem to stay the same for too long.  Others (and this is most of us) hate change, resisting even the smallest manifestations.  We like consistency because it gives us a sense of predictability reinforcing our illusion of control.  If we believe we can rely on things as they are, we don’t have to fear the unknown.  This fear is really just anxiety that we won’t be able to handle whatever changes occur in the future.

Despite this sense of anxiety there is not a single person among us who can look back through their lives and not see evidence of an ability to handle change.  We’ve all faced changes at some point in our lives regardless of our age.  In fact, small children change on a daily basis and usually manage to adapt.  As we age, we may become more invested in the status quo.  Yet we can still find even more examples of accepting change.  We may have been dragged kicking and screaming into a different scenario from the one we were used to, but still most of us find a way eventually to see things as they are and adjust.  Sometimes change brings hidden blessings which may not be recognized immediately but might become evident in hindsight.  Looking back can sometimes help us move forward when change is required.

Sometimes change is forced on us for one reason or another.  At other times the status quo itself is causing our suffering and we need to create our own change.  This can be difficult.  Inertia is a powerful force.  Also, just as changes in the world impact our own personal lives, so changes we make to our personal lives can impact the lives of others.  This doesn’t make those changes good or bad, right or wrong.  But it does help to remember that all decisions have consequences, some unexpected and unanticipated.  Being willing to accept and deal with the consequences whatever they are is one of the characteristics of resilience.  This is a quality defined by Webster’s Dictionary as “the ability to recover from or adjust easily to misfortune or change.”  You may have heard the saying “pain is inevitable but suffering is optional.” Resilience is one of the traits that help us deal with the pain without buying into the suffering.

So what does all of this have to do with yoga, Pilates or exercise in general, my usual themes?  Basically it’s this – since each day is different and change is all around us all of the time, our practice can be impacted.  One of the many benefits of practice is that it helps us to deal with stress.  Practice can be an anchor in a raging sea of change.  There can be a comfort in the experience of simple breath and movement.  One of the things I often tell students is that if you really focus on connecting breath and movement there is usually no room in your head for anything else.  This can provide a brief respite from the ills of the world.  In fact, practice might help you to remember that in this moment right now there is still a lot that is OK.  We as humans seem to naturally gravitate to noticing what’s wrong more often than what is right. Those of you who take my classes know that at the end of each class I always offer gratitude for being able to move and breathe.  This is something I learned from yoga teacher Seane Corn and I am grateful to her for passing on that tip.  It has served me well.

Another consequence of daily changes is that some days are better than others physically as well as mentally.  As we get older, we tend to focus on the negative aspects of these feelings, but they are not limited to older people.  Everyone has days when they feel like they could conquer the world and other days when staying in bed seems like the only option.  On days like that it helps to remember that practice can be a source of comfort.  If you take classes regular, the group can also be a support.  Just like you feel differently on some days, your practice can be different, too.  If you’re not feeling terribly energetic or if you are bogged down by some difficulty, don’t blow off your practice. Instead allow it to change just as you are changing.  Be gentle.  Take it slow.  Don’t work so hard.  Bend your knees more.  Try using an extra blanket or other prop to make it less stressful.  Or just take Child’s Pose and breathe whenever you feel like it. You can also just completely avoid poses that are painful or difficult.  Or use modifications even if that’s something you rarely do.  There are no expectations you need to live up to. Your practice is for you alone.  There may be a benefit to others due to the effects of your practice on you, but that’s not the point.  The ultimate goal is for you to take care of yourself.  So just for today whatever will help you do that is the right thing to do.  Tomorrow will be different.

Rounds Requests Audit of Indian Health Service

Rounds Requests Audit of Indian Health Service

July 6, 2016 

WASHINGTON – U.S. Senator Mike Rounds (R-S.D.) today formally requested an audit of the financial aspects of hospital and health care, medical services and overall financial management at Indian Health Service (IHS). In a letter sent to the Inspector General of the U.S. Department of Health and Human Services (HHS), Rounds outlined specific areas of focus for the audit based on an in-depth profile analysis conducted by Rounds and his staff.

“Despite the agency’s well-documented history of failing to meet trust obligations by not providing quality health care, there has never been a systemic review of IHS to address and ultimately reform these issues in attempt to improve health outcomes for tribal members. Furthermore, there has been a continuing lack of consultation with the tribes,” wrote Rounds.

“Based on our review, our office has identified primary areas of concern with IHS’s administrative management, financial management and the quality of care delivered at IHS facilities. We are attempting to address many of the administrative concerns through legislation in the House and Senate. We believe an audit, similar to what was recently conducted at the Veterans Health Administration, which identified shortfalls and recommended solutions, is a potential model for addressing these critical financial and quality issues within IHS.”

During a Senate Indian Affairs Committee field hearing in Rapid City on June 17, 2016, HHS Acting Deputy Secretary Mary Wakefield stated that she ‘would welcome’ such an audit. Similarly, on April 15, 2016, the Great Plains Tribal Chairman’s Association passed a resolution urging Congress to demand an audit of IHS.

The full text of the letter is available below:

 July 6, 2016

The Honorable Daniel R. Levinson

U.S. Department of Health & Human Services
Office of Inspector General
330 Independence Avenue, SW
Washington, DC 20201

Dear Inspector General Levinson:

Pursuant to the United States trust obligations to Native American tribes, the federal government established Indian Health Service (IHS) to provide health care for federally recognized tribal members. However, for decades IHS has been criticized by tribes and federal officials for their shortcomings outlined in numerous Government Accountability Office (GAO) reports. Despite the agency’s well-documented history of failing to meet trust obligations by not providing quality health care, there has never been a systemic review of IHS to address and ultimately reform these issues in attempt to improve health outcomes for tribal members. Furthermore, there has been a continuing lack of consultation with the tribes.

Most recently, a Great Plains Area hospital diverted emergency services because the hospital has been unable to meet basic requirements set by the Centers for Medicare and Medicaid Services (CMS). It now faces potential termination of its CMS certification. Additionally, a second hospital within the Great Plains Area lost its CMS certification and two other Great Plains Area hospitals are in jeopardy of losing this necessary requirement. We believe these CMS issues plaguing the Great Plains Area IHS facilities appear to be symptoms of a larger problem.

Therefore, our office has been researching IHS’s history, funding, systems management and organizational structure. During our review, we have evaluated GAO reports, Congressional Research Service (CRS) publications and the Department of Health and Human Services (HHS) fiscal year budget books. Further, we have had discussions with IHS officials and continue to have frequent communication with tribal leadership. Our analysis strongly suggests there are indeed systemic management and quality concerns. In the Great Plains Area, particularly in South Dakota, this issue has reached a crisis stage.  People are literally dying waiting for a solution. 

Based on our review, our office has identified primary areas of concern with IHS’s administrative management, financial management and the quality of care delivered at IHS facilities. We are attempting to address many of the administrative concerns through legislation in the House and Senate. We believe an audit, similar to what was recently conducted at the Veterans Health Administration, which identified shortfalls and recommended solutions, is a potential model for addressing these critical financial and quality issues within IHS. Such action is supported by the Great Plains Tribal Chairman’s Association, which recently passed a resolution calling upon Congress to demand an audit of IHS (enclosed).

I specifically mentioned the idea of an IHS financial audit to HHS Acting Deputy Secretary Mary Wakefield during the Senate Committee on Indian Affairs field hearing on June 17, 2016. Dr. Wakefield responded that HHS “would welcome” such an audit. With your support and understanding of the need to identify issues of concern with IHS, I am respectfully asking you to pursue this important investigation. My request is as follows:

AUDIT OF THE HEALTH CARE DELIVERY SYSTEMS AND FINANCIAL MANAGEMENT PROCESSES OF THE INDIAN HEALTH SERVICE.

I am respectfully requesting that you conduct an audit of the financial aspects of hospital and health care, medical services and overall financial management of Indian Health Service (IHS) within the Department of Health and Human Services. I request the audit address each of the following:

Budget Allocation and Distribution: There is no funding formula to determine how the budget is distributed between regions; just historical distribution.

1.      How is IHS able to appropriately operate without an overall funding formula? How does IHS arrive at their distribution decisions without a formula? Are there specific reasons for not having such a formula?

a.      How are area directors informed of their budget allocation and how are they instructed to distribute their allocation amongst the area’s facilities?

b.      Are local facilities able to manage their own budget or do they wait to receive allocation from the area office?

2.      IHS has previously estimated that, in FY2015, it would have needed an additional $645 million to provide additional services for Purchased and Referred Care (PRC) eligible IHS beneficiaries. What is a realistic analysis of PRC shortages?

a.      How does each area employ their PRC program and medical priority levels?

b.      Why do different areas have different medical priority levels?

3.      Is the amount spent on administration compared with direct health care comparable to private health care standards?

a.      What is the allocation of budget spent on administration compared with the allocation of budget spent on direct health care?

b.      Does this vary between IHS-operated and Tribally-operated facilities?

c.       Tribal members report that a facility may have a number of vacant positions, yet the facility is not actively advertising employment opportunities. There is speculation that some full-time equivalent (FTE) positions are created with no intent to fill, but to support a high salary classification for a supervisor. Are there FTE employees that IHS has no intention to fill/has not filled for over 36 months?

                                                  i.      Since the vacancy rate is so high, what happens with the budgeted personnel money that is not spent because FTE’s are open?  Is this money redeployed?

                                                ii.      If so, how is the redeployment of funds determined?

d.      According to IHS’ annual budget book, there are 3700 “Medicaid reimbursable FTE.”

                                                  i.      How many are certified coders?

                                                ii.      Is this amount necessary?

4.      Are there consistent tracking of “dual eligible” patients (e.g. Patients eligible for Medicaid, IHS and/or other federal healthcare programs)?

a.      How are “dual eligible” patients managed?

5.      We noticed extreme discrepancies in the HHS Fiscal Year (FY) 2017 Budget Book for IHS. The FY2017 annual budget book showed that IHS intended to spend $40 million more on tribally-operated facilities compared to federally-operated facilities in the Great Plains Area, even with the area being highly IHS-operated. IHS/HHS officials analyzed this discrepancy and recently posted revised documents showcasing almost an $80 million change in funding distribution in the Great Plains Area alone. Were these errors only documented incorrectly, or was this funding inappropriately distributed too?  What was the budget justification for suddenly correcting the error?  How many years has this error gone unnoticed?

a.      Were area directors made aware of this error? If so, when?

b.      If the funding was correctly distributed, how were area directors correctly distributing this funding while not noticing the budget book error?

Facilities and Asset Management: Management structure and process for construction and maintenance projects, the facilities leasing process, the purchasing, distribution and use of pharmaceuticals, medical and surgical supplies, medical devices and equipment.

1.      How are long-term growth facility construction plans determined? Is there a priority based upon population trends, history and care demands?  What analysis is considered? Are buildings depreciated at a 30-year lifecycle?  What happens at the end of the lifecycle, are they remodeled or replaced?

2.      Is the maintenance budget updated/increased to reflect increase maintenance expense with the addition of new facilities? Is the increase enough to support the growth of facilities?

3.      How is equipment purchased and deployed? Is there a comprehensive plan for maintaining basic necessary equipment? How do facilities request equipment maintenance and upgrades? What resources are available to satisfy these requests?

4.      How many procurement contracts/awards were authorized by IHS utilizing the Buy Indian Act (48 C.F.R. 370.501) authority? How does this compare to all awards/contracts made through IHS in the last five years?

a.      What process do IHS facilities use to ensure compliance with 48 C.F.R. 370.501?

Transparency: There has been a lack in transparency in the culture of IHS for many years. Tribal leadership has consistently requested for increased transparency and more open communication between the IHS and the people they serve.

1.      How are tribal/residual shares determined for each tribe? What are those share amounts?

2.      How are funds distributed from area office budgets to local service units?  Are there set formulas or budgets for this?

3.      How does IHS audit or evaluate that funds were distributed appropriately?

a.      Are there periodic or end-of-year records to document how the budget is actually distributed?

b.      Are these records audited following generally accepted accounting principles (GAAP)?

4.      Are there checks and balances to assess potential fraud or misuse of funds?

We look forward to working with you to address the issues we have already identified and to learn more about other issues that your investigation uncovers. My office would be happy to provide any resources available to us to assist in your efforts. We would also be available to meet to discuss any questions or refinements to this request.  Please contact Gregg Rickman of Senator Rounds, at 202-224-5842 if you or your staff have any questions concerning this request.

Sincerely,
M. Michael Rounds
United States Senator

FDA Approves First Absorbable Stent for Coronary Artery Disease

 

July 5, 2016

The U.S. Food and Drug Administration today approved the first fully absorbable stent to treat coronary artery disease. The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), which releases the drug everolimus to limit the growth of scar tissue, is gradually absorbed by the body in approximately three years.

“The FDA’s approval of the Absorb GT1 BVS offers a new treatment option for individuals who are candidates for angioplasty, but would prefer an absorbable device rather than a permanent metallic coronary stent,” said Bram Zuckerman, M.D., director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health.

Coronary heart disease is responsible for about 370,000 deaths each year in the U.S., according to the National Heart, Lung, and Blood Institute. The condition develops when cholesterol-containing deposits build up and narrow the coronary arteries, decreasing blood flow to the heart. This can cause chest pain (angina), shortness of breath, fatigue or other heart disease symptoms. Doctors often treat coronary artery disease with a procedure called angioplasty to widen the artery using a metal stent. Scar tissue can form within the stent causing the artery to narrow again (restenosis). Drug-eluting stents temporarily release a drug, typically for a few months after stent placement, to combat the formation of scar tissue.

The Absorb GT1 BVS is manufactured from a biodegradable polymer called poly(L-lactide), which is similar to materials used in other types of absorbable medical devices, such as sutures. The device’s absorption by the body gradually eliminates the presence of foreign material in the artery once the stent is no longer needed. After absorption, there are only four very small platinum markers embedded in the walls of the artery, which help cardiologists identify where the Absorb GT1 BVS was originally placed.

In approving the Absorb GT1 BVS, the FDA evaluated data from a randomized trial of 2,008 patients, which compared the rate of major adverse cardiac events between the Absorb GT1 BVS and a drug-eluting metallic stent. After one year, the Absorb GT1 BVS group showed a major cardiac adverse event rate of 7.8 percent, which was clinically comparable to the rate of 6.1 percent observed in the control group. In addition, after one year, the rate of blood clots forming within the devices was 1.54 percent for the Absorb GT1 BVS and 0.74 percent rate for the control.

Possible adverse events that may be associated with the procedure to insert the Absorb GT1 BVS or with the Absorb GT1 BVS itself include allergic reactions to materials in the device or medications used during the procedure, allergic reaction to the drug everolimus, infection or irritation at the catheter insertion site, internal bleeding, the development of abnormal connections between arteries and veins, embolism, or other coronary artery complications that may require medical intervention and that could lead to death.

The Absorb GT1 BVS is contraindicated for patients who have a known hypersensitivity or allergy to everolimus or the materials used in the device, such as poly(L-lactide), poly(D,L-lactide), or platinum. It is also contraindicated for those who are not candidates for angioplasty, have sensitivity to contrast, or who cannot take long-term aspirin therapy along with other blood-thinning medications (antiplatelet agents).

The Absorb GT1 BVS is manufactured by Abbott Vascular in Santa Clara, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Whole Body Cryotherapy (WBC): A “Cool” Trend that Lacks Evidence, Poses Risks

Your rheumatoid arthritis is flaring up? A trainer at your local gym suggests a safe and easy way to treat it: a three-minute session in a freezing tank, called whole body cryotherapy (WBC). He says not only will WBC help you put an end to rheumatoid arthritis pain better than an ice bath or pack, but also promises that a couple sessions will help with depression and weight loss!

Not so fast.

The problem is, this so-called “treatment” hasn’t been proven to do any of these things.

And despite claims by many spas and wellness centers to the contrary, the U.S. Food and Drug Administration (FDA) does not have evidence that WBC effectively treats diseases or conditions like Alzheimer’s, fibromyalgia, migraines, rheumatoid arthritis, multiple sclerosis, stress, anxiety or chronic pain.

“Based on purported health benefits seen in many promotions for cryotherapy spas, consumers may incorrectly believe that the FDA has cleared or approved WBC devices as safe and effective to treat medical conditions,” says Aron Yustein, M.D., a medical officer in the FDA’s Center for Devices and Radiological Health. “That is not the case.”

In fact, not a single WBC device has been cleared or approved by the agency in support of these claims.

Nevertheless, a quick Internet search for the term “whole body cryotherapy” turns up a wealth of websites extolling the praises of WBC for a number of serious illnesses and conditions, including:

  • Asthma
  • Alzheimer’s
  • Anxiety
  • Chronic pain
  • Depression
  • Fibromyalgia
  • Insomnia
  • Migraines
  • Multiple sclerosis
  • Osteoarthritis
  • Rheumatoid Arthritis
  • Weight Loss

Those who sell WBC machines and facilities that operate them may also claim that WBC can improve blood circulation, increase metabolism, improve recovery and soreness after workouts, and relieve joint and body pain.

“Given a growing interest from consumers in whole body cryotherapy, the FDA has informally reviewed the medical literature available on this subject,” Yustein says. “We found very little evidence about its safety or effectiveness in treating the conditions for which it is being promoted.”

What is Whole Body Cryotherapy?

Simply put, cryotherapy is “super-cooling” of the body for therapeutic purposes. Cryotherapy can include the use of products such as ice packs on a localized portion of the body, such as the lower back. Whole body cryotherapy involves exposing the body to vapors that reach ultra-low temperatures ranging from minus 200 to minus 300 degrees Fahrenheit. Those who choose to have a WBC treatment are enclosed in relatively confined spaces, typically for two to four minutes, in one of two ways:

  • A person stands alone in an individual-size can-like enclosure that is open at the top. A person’s torso and legs are enclosed in the device and exposed to frigid temperatures while the head remains above the enclosure at room temperature.
  • Several people sit or stand in a totally enclosed chamber for two to four minutes. The entire body including the head is exposed to freezing temperatures, generated by liquid nitrogen. Some cryotherapy devices work by way of cooling the air in a circuit.

What actually happens physiologically to the body when a person stays within these chambers for two to four minutes? What effects do such cold temperatures have on the blood pressure, heart rate, and metabolism?

“We simply don’t know,” says FDA scientific reviewer Anna Ghambaryan, M.D., Ph.D. “At this time, there’s insufficient publicly available information to help us answer these questions.”

However, she notes that while the healing benefits of cryotherapy remain unconfirmed, the potential risks are readily apparent.

“Potential hazards include asphyxiation, especially when liquid nitrogen is used for cooling,” says Ghambaryan. The addition of nitrogen vapors to a closed room lowers the amount of oxygen in the room and can result in hypoxia, or oxygen deficiency, which could lead the user to lose consciousness. Moreover, subjects run the risk of frostbite, burns, and eye injury from the extreme temperatures.

Talk to Your Doctor First

If you decide to try WBC, know that the FDA has not cleared or approved any of these devices for medical treatment of any specific medical conditions.

The FDA is also concerned that patients who opt for WBC treatment—especially in place of treatment options with established safety and effectiveness—may experience a lack of improvement or a worsening of their medical conditions.

Yustein says it’s a good idea to discuss using WBC with your physician before you try it or if you’re using it already.