CAMLAW: Complementary and Alternative Medicine Law Blog

Podiatrists add CAM to their practice

(Michael H. Cohen Attorney ) — Mon, 01 Mar 2010 14:04:11 -0500

Acupuncture and myo-fascial release are among the popular therapies.

With the surge in popularity of complementary and alternative medicine over the last decade, it should be no surprise that Illinois podiatrists are also using these methods.

According to a 2008 survey from the National Center for Complementary and Alternative Health (part of the National Institutes for Health), 38 percent of Americans use some form of complementary and alternative medicine. And at least two Chicago-area podiatrists have incorporated some of the more popular CAM therapies, such as acupuncture, for her patients.

“I provide acupuncture for many conditions, and will soon have an acupuncturist on staff at my office to treat all types of aliments,” said Lisa Schoene, DPM, who has offices in Gurnee and Chicago. Schoene said that nerve injuries like tarsal tunnel or neuritis tend to respond well to acupuncture and it often works well on painful scars after surgery and tendon and joint pain, too.

One of Dr. Schoene’s patients, Chicago marketing professional Catherine Morgan, 47, benefitted from Dr. Schoene’s focus on complementary medicine. Morgan injured her foot last spring during one of her tap dance classes and took some time off from dancing to heal. However, the pain persisted and she ended up seeing Dr. Schoene in October.

“Dr. Schoene takes tap classes herself and she treats a lot of dancers at the Joel Hall Dance Center in Chicago so I thought it would be good to see a doctor like that for my injury,” she said.

In addition to acupuncture, Dr. Schoene used Traumeel shots that helped reduce the pain. Traumeel is an anti inflammatory, homeopathic medication containing 12 botanical substances and 2 mineral substances. The shots, combined with manipulation, physical therapy and electric stimulation helped Morgan recover from her injury to the extent that she would take a scheduled vacation to Buenos Aires and tango every night there.

Dr. Schoene said acupuncture is based on inserting tiny needles at key points in the body to bring about pain relief and healing.

“I’m more inclined to use alternative therapies today than ever before because I find that doctors who use them tend to take into consideration the entire patient when treating,” Morgan said.

Buffalo Grove podiatric physician Catherine Halinski, DPM, has also been a big proponent of complementary and alternative medicine technique for the last decade.

“I often use a technique called myofacial release which is a technique made popular by physical therapists and chiropractic and osteopathic physicians to treat musculoskelatol problems, including foot and ankle conditions,” she said. During myofacial release, Halinski gently palpates or manipulates soft tissue.

“I have been using alternative methods since 2000 and I was introduced to myofacial release therapy,or MFR, in 2000 as well,” she said. “Many of my patients are interested in non surgical options so they can consider all approaches to their problems.”

Wheeling resident and bowling enthusiast Leslie Ridgeway, 50, sought out Dr. Halinski for her plantar faciitis a few years ago and credits myofacial release with helping her avoid surgery. Ridgeway worked in a retail environment for several years and believes the constant standing exacted a toll on her legs and feet.

“I was skeptical at first when Dr Halinski suggested myofacial release,” she said. “I had never had a massage before but I soon noticed a change. My calves had developed a lot of tightness from my compensating for my foot injury so she needed to work that out to help my foot problem,” Ridgeway said. Over the course of 10 treatments, Halinski and her staff were able to cure Ridgeway’s plantar fasciitis and help her avoid surgery.

For her part Ridgeway was so impressed she started training for a career as a massage therapist and now works for Halinski as a physical therapy aide.

“I have full function of my feet and have resume bowling every week,” she said.

About the IPMA

The IPMA is based in Chicago and represents more than 600 podiatrists throughout the state of Illinois. For more information about podiatric medicine, visit the Illinois Podiatric Medical Association’s website at www.ipma.net or on Facebook at www.facebook.com/IllinoisPodiatricMedicalAssociation or call 312.427.5810.

Our health care, business law, and alternative medicine law attorneys regularly consult and advise on telemedicine and other health care law and business legal matters involving online enterprises and emerging or established companies. For legal advice concerning telemedicine and other health care practices, whether involving physicians, nurses, psychiatrists, psychologists, life coaches, fitness consultants, or CAM providers such as acupuncturists, nutritionists and dietitians, homeopaths, naturopathic physicians, hypnotherapists, energy healers, and others, contact our health care lawyers today.

Our law firm has many successes with health care and business law clients, whose practices are transforming the business and health care landscape as we know it.

Michael H. Cohen is an attorney providing business legal advice to green entrepreneurs and companies, and health care law advice to businesses and physicians, acupuncturists, naturopaths, homeopaths and others in the holistic health, wellness, and green industries. As a founding attorney of the Global Vision Law Group, he represents businesses poised for vertical lift, whose leaders are conscious, intuitive, and committed to shaping a better world. Michael also advises medical spas and integrative medicine clinics, physicians, chiropractors, naturopathic physicians, massage therapists, energy healers, nutritionists and herbalists, dietary supplement and cosmetics companies, and businesses with bio-energy and other technologies and medical devices. Michael offers the Entrepreneur’s Legal Toolkit as a series of legal guides to businesses. The first legal e-book deals with Contract Essentials, giving legal tips every business needs to negotiate its legal agreements; the second addresses legal issues faced by multi-level marketing companies and individuals involved in multilevel marketing and direct sales; and the third one so far is a HIPAA Regulations and Privacy Manual at far less the cost than it would take for an attorney to prepare.

Michael also sponsors Being Central, a Portal for Potential, which gives access to other, pre-paid legal services.

Read reviews of Michael’s work on the Complementary and Alternative Medicine Law Blog. And visit the Flat Rate Legal Services page for information on legal services offered at a flat rate or project fee (such as incorporation for entrepreneurs, review and drafting of business contracts, trademark, and health law services for CAM providers and others).

Michael’s clientele through the Global Vision Law Group includes businesses not only in California, New York, Maryland, Massachusetts, Washington, D.C., and other U.S. states, but also abroad. To speak with a lawyer about health care law issues pertaining to complementary and alternative medicine, or to consult a business lawyer about laws and legal issues for entrepreneurs and new enterprises that are seeking legal advice, contact the Global Vision Law Group today.

UNESCO CAM conference includes energy medicine

(Michael H. Cohen Attorney ) — Mon, 01 Mar 2010 14:01:59 -0500

The UN focuses on Universal Energy as part of a CAM conference.

HCM CITY — The benefits of complementary and alternative medicine in serving public health were highlighted by local experts at a conference held in HCM City on Wednesday.

At the conference held by the UNESCO Centre for Public Health, they said this branch of medicine, a group of diverse medical and health care systems, practices, and products that are not generally considered part of conventional medicine, gave patients more health care choices.

Alternative medicine had also become popular in industrially advanced countries including the US, they noted.

Professor Nguyen Tan Si of the Open International University for Complementary Medicine in the Sri Lankan capital of Colombo, said that harmful side-effects and high costs were some of the weaknesses of western medicine.

Moreover, western medicine could not treat all illnesses, he said, adding that nearly 80 per cent of diseases did not have a cure under this system. It had also not been able to find the cause for 21 diseases, he said.

He said because of all these reasons, complementary and alternative medicine has attracted a lot of people since 2000.

The therapies of complementary and alternative medicine include acupuncture, ayurveda, biofeedback, chelation therapy, deep breathing exercises and diet-based therapies, Si said.

A survey conducted by the National Center for Complementary and Alternative Medicine in the US found 74.6 per cent of its residents used complementary and alternative medicine therapies and 54.9 per cent used it in conjunction with western medicine.

Most of them use the complementary and alternative medicine to treat and prevent problems involving their joints.

Another study conducted by the Health Forum under the American Hospitals Association also showed that many hospitals in the US are providing complementary and alternative medicine therapies to meet patients' demands.

In 2008, 37 per cent of hospitals in the US used these therapies, an increase of 26.5 per cent over 2005.

Complementary and alternative medicine has been applied widely in Canada, the UK, Ireland, France, Germany and Australia, the conference heard.

According to Si, it would be beneficial for Viet Nam, which imports a large number of drugs and has the problem of overloading at all major hospitals, to apply and develop these alternative therapies.

Experts at the conference also noted that "Universal Energy," one of the complementary and alternative medicine therapies, has also been applied in other fields including agriculture in Viet Nam in order to limit the use of chemical fertilisers and insecticides to protect farmers' health as well as the natural environment. — VNS

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Integrative medicine helping oncology patients

(Michael H. Cohen Attorney ) — Mon, 01 Mar 2010 13:33:30 -0500

Integrative medicine is helping oncology patients and new developments are being featured in various conferences.

Integrative medicine helps patients in a Chicago hospital:

Cancer patients find relief in integrative medicine services

EUREKALERT
Contact: Angela Salerno
asalerno@nmh.org
312-926-8327
Northwestern Memorial Hospital

Northwestern Memorial's Integrative Oncology Program aims to ease pain and help patients manage cancer

CHICAGO- The very instant Penny Kukovec was diagnosed with breast cancer her world permanently changed. Suddenly, it felt as if her life was out of her control. She felt powerless and overwhelmed. There were so many unanswered questions. Why me? What's next? What about my family? The feelings Kukovec experienced are felt by many cancer patients following their initial diagnosis and as they pursue treatment. In an effort to effectively and compassionately respond to these worries, as well as address common side effects associated with cancer treatment, Northwestern Memorial Hospital and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University now offer integrative oncology services.

"When a patient is diagnosed with cancer many of them want to fully participate in their recovery, but don't know where to begin. This program gives them control over their treatment," said Julian Schink, MD, chief of Gynecologic Oncology at Northwestern Memorial and the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

The integrative oncology services are part of a larger 360 Care Program that recently launched aimed to address cancer patients' needs from every angle through treatment that extends beyond medical therapies, to include counseling, stress management and integrative medicine. Integrative oncology services include acupuncture, massage, energy healing and naturopathic medicine offered by Northwestern Memorial Physicians Group's Center for Integrative Medicine and Wellness.

"Our goal is to treat the whole person, not just their illness," said Melinda Ring, MD, medical director of the Center for Integrative Medicine and Wellness. "Research suggests that a holistic approach can alleviate stress and anxiety, as well as the physical pain and discomfort patients often experience while undergoing cancer treatments by activating the body's innate healing process."

While there is little research to explain exactly how integrative approaches like acupuncture work, researchers at the National Institute of Health state complementary therapy such as acupuncture do improve the body's immune system. In an oncology setting, integrative approaches provide an effective way to manage symptoms, alleviate side effects, and help patients restore their sense of control and vitality.

"My body was hit hard with trauma. I was so tired, my joints hurt and my muscles were tense. I knew I needed more help. When I began massage therapy my muscles relaxed, and it helped me release my emotions. It reminded my body that it can relax in spite of what I am going through," said Penny Kukovec, patient at Northwestern Memorial.

Common side effects of chemotherapy and radiation treatment for cancer include muscle tension, aches, pains nausea, vomiting and fatigue. The main role of complementary medicine is to provide supportive care and reduce adverse effects while helping the patient cope.

"Unfortunately, the side effects associated with conventional therapies often cause patients to end their treatments prematurely, or require that we take a less aggressive approach," said Schink. "We've seen this occurrence decrease with the addition of integrative oncology services."

"The medicine I was taking for my cancer caused nerve damage in my hands and feet. It was very uncomfortable. Acupuncture helped relieve the pain," said Nancy Amicangelo, patient at Northwestern Memorial.

There is evidence that integrative approaches may also play a role in reducing the rate of depression among cancer patients. Services such as massage therapy are believed to have a short-term effect on reducing anxiety related to depression among patients.

"You're sick, your hair falls out, and your family is stressed. When you are diagnosed it's sometimes all that you can think about. The massages offer me a chance to escape," said Kukovec.

While integrative medicine does not offer a cure for cancer, there is strong evidence that it positively affects the patient. Studies show 77 percent of cancer patients who incorporate complementary approaches believe it improves their quality of life, and 73 percent state it makes them feel hopeful. In addition, 71 percent say it helps to boost their immune system.

###

All patients under the care of a Northwestern Memorial oncologist are eligible to receive free integrative medicine services as part of their cancer treatment. The 360 Care Program was made possible by a generous gift from Abra Prentice Wilkin, board member of Northwestern Memorial Hospital and longtime supporter of the hospital.

For more information about integrative oncology at Northwestern Memorial or to schedule an appointment, call 312-926-DOCS (3627).

Integrative medicine showcased at a conference:

Faculty and speakers include Mark Houston, MD, Associate Clinical Professor of Medicine, Vanderbilt Medical School, and Director of Hypertension Institute, James Forsythe, MD, Nationally recognized leader in integrative oncology and many more. David Corbin, host and star of Pass It On, author of Illuminate and Harnessing the Positive Power of Negative, will give a special presentation that will leave you standing on your seats.

The conference will present 7 modules including Integrative Cardiology, Oncology, Gut and Immunity, The Brain, Memory, Mood and Sleep Disorders, Obesity, Diabetes and Metabolic Syndrome, Anti-Aging, HGH, HRT And Menopause, and a Friday night kick-off party add to the excitement of IFIM's integrative medicine conference. Physicians may earn AMA PRA Category 1 Credits. Chiropractors, Naturopaths, Nurse Practitioners, Certified Nutritionists and many other practitioners will also receive CE credits. Additionally, The IFIM is launching a certification program to become Board certified in Integrative Medicine.

"The Summer conference draws novice and seasoned professionals alike across from the medical spectrum," said Dr. Steven Ross, President for the IFIM. He adds, "With the high caliber of presenters, comprehensive assessment and treatment protocols and new skills to learn, this is truly a conference the practitioner will want to attend."
The Institute for Integrative Medicine is dedicated to educating physicians and other health care professionals on the latest findings and emerging procedures in complementary, alternative and integrative (CAIM) medicine. The IFIM is a leader in integrative medicine; “our goals are to improve physician skills, knowledge and diagnostic procedures, business acumen as they relate to complementary and alternative medicine; to support integrative medicine research; and to develop awareness of alternative methods of medical treatment.”, said Dr. Padilla, CEO of the IFIM.
“Integrative medicine treats the whole person, not simply the disease. It is quickly becoming mainstream medicine in the eyes of the public and the medical community,” said Dr. James Padilla. A guiding principle within integrative medicine is to use therapies that have high-quality evidence to support them, in terms of treatment and prevention.

Practitioners can register by visiting www.TheIFIM.com.

If you would like more information about this topic, or to schedule an interview with Drs. Ross or Padilla, please contact them at 858-676-1166 or e-mail Dr. Ross at DrRoss@TheIFIM.com.

Dynamic chiropractic argues for a paradigm shift:

Preventing Disease vs. Promoting Health: A Big Difference

Of course, the most important aspect of health promotion and wellness is not disease prevention, but an emphasis on the patient as an integrated whole. Sickness is not just a body part or system exhibiting pathological changes. The medical solution holds that the best way to approach the patient is to not only treat disease after it occurs, but to prevent disease from occurring. This promotes a vision of the absence of disease as health, rather than a forward-looking goal of promoting health and wellness through healthy lifestyles. This point of view is exemplified by the chairman of the American Association of Integrative Medicine, who notes that to control health care costs, "We only treat disease after it occurs. The best way to reduce costs is prevention."³

If the medical paradigm continues its focus on disease and its underlying pathology, then how can we change disease care to health promotion? Broadly speaking, the emphasis on health care reform is not going to solve the problem without a paradigm shift in medicine. This is more difficult that the proverbial camel passing through the eye of a needle. The answer would seem to be health education reform.

The group within the health care system ostensibly charged with health education is no more focused on health promotion than is medicine. Health and physical education instructors, especially those in middle schools, high schools, colleges and universities, are often more focused on athletics than health promotion. The image many carry of physical-education teachers is that of an overweight coach who promotes athletic participation rather than promoting healthy lifestyles and lifelong activities that maximize fitness. The win-at-all-costs ethos is often fostered by the current health education system, rather than emphasizing excellence that promotes a healthy body and ethical character.4

How can we have a healthy society that fills the stands and couches with vegetative spectators? Where is health promotion in a society that tears apart the bodies of athletes while the masses become less fit watching the spectacle? Just as destructive to the bodies of individuals are the activities of the weekend warriors who participate in adult sports that lead to disability as they age. Activities that promote lifelong fitness are safer and more appropriate.

Promoting Healthy Lifestyle Choices

I have sat through health education courses in which the instructors presented the current medical paradigm with little emphasis on healthy lifestyle choices. While there is more emphasis today on eating healthy food, smoking cessation and promoting positive lifestyle changes, there needs to be more discussion of alternative and complementary therapies. For those chiropractors who wish to serve their patients as healthy lifestyle coaches, it is important that they also educate health and physical education instructors as to the role the chiropractic profession plays in health promotion and wellness.

Patients are choosing alternative care and looking for practitioners who have the knowledge and education to help them make healthy choices. Why not teach students in our educational institutions as to alternative options for health promotion and wellness? The current disease-prevention model of busy medical practitioners encourages costly screening for risks of specific diseases, but commonly does not allow time for conservative health promotion counseling. Health education reform and health care reform must emphasize reimbursement for those disciplines, including chiropractors who choose to practice as health educators.

One of the most successful chiropractic educational contributions to public service has been the Straighten Up program, which now has worldwide recognition. This type of program should serve as a model for other ways of fostering positive lifestyle changes. An animated presentation of theStraighten Upprogram to health-education classes gives true public service while presenting the chiropractic profession in a positive way. A presentation whereby students participate in the activity is suitable for grade school on up. TheStraighten Up program is being expanded to other areas of fitness. We are far beyond screening for postural analysis in malls as a practice-building activity, under the guise of public service.

A discussion of the importance of individual motion segment movement of the spine can be presented to health educators. Research headed by Henderson at Palmer University and Cramer at National University of Health Sciences demonstrates the effects of induced hypomobility and restricted motion on the zygapophyseal joints of the spine. This series of studies suggests the practicality that a line of research can attain when funding and cooperation from more than one chiropractic institution are maintained.^5-9

Massage therapy conferences educate practitioners:

The Massage Therapy Foundation works to advance the knowledge and practice of massage therapy by supporting scientific research, education and community service. The foundation announced on Feb. 25 that it had received a $30,000 grand from the National Center for Complementary and Alternative Medicine (NCCAM), which is a division of the National Institutes of Health.

The grant will help support the second “Highlighting Massage Therapy in Complementary and Integrative Medicine (CIM) Research” conference to be held May 13-15, 2010, in Seattle, Washington.

“This NCCAM conference grant is an important demonstration of support—support of massage therapy’s presence in integrative medicine and support of the Massage Therapy Foundation’s role in bridging research and massage therapy practice," said Diana Thompson, immediate past president of the foundation and chair of the conference planning committee.

The “Highlighting Massage Therapy in CIM Research” conference will bring together massage and manual therapy practitioners, educators, CIM researchers, allied health professionals, and others interested in massage research. Current research related to massage and manual therapies will be presented, with a special focus on translational research and public health. To view the slate of speakers and to register for the conference, please visit www.massagetherapyfoundation.org/researchconference2010.html.

A CAM desk reference comes into the light:

The Academic Consortium for Complementary and Alternative Health Care (ACCAHC) has recently published the Clinicians’ and Educators’ Desk Reference on the Licensed Complimentary and Alternative Healthcare Professions.

This essential desk reference correctly states that it is time for traditional health care to become more integrated with complementary therapies, and that one of the primary blocks to that has been the lack of knowledge of traditional providers about the licensed professions that provide alternative care.

The public is more aware of complementary and alternative therapies than many clinicians, as evidenced by the huge rise in popularity of their use. This book is focused on fostering more collaboration among CAM practitioners and mainstream providers. The major chapters include Acupuncture and Oriental Medicine, Chiropractic, Massage Therapy, Direct-Entry Midwifery, and Naturopathic Medicine.

In addition, there are appendices on Ayurvedic Medicine, Holistic Medicine, Holistic Nursing, Homeopathy, Integrative Medicine, and Yoga Therapy.

Integrative medicine information is presented in NC:

As part of his continuing health series, John C. Pittman, MD, of the Carolina Center for Integrative Medicine (CCIM), will present two presentations focusing on Autism Spectrum Disorders and ADHD that are free and open to the public. “Healing from Autism, ADHD, and other Autism Spectrum Disorders” will be held on Tuesday, February 23rd from 7-8PM at 4505 Fair Meadow Lane, Suite 111 in Raleigh. “ADHD, Learning Disabilities, and Autism Spectrum Disorders: Helping Your Child from the Inside Out with Targeted Nutrition and Integrative Medicine” will be presented from 6-8PM on Wednesday, February 24th at the Fuquay Varina Community Center located at 820 S. Main Street.

“Children with autism and other autistic spectrum disorders (ASDs) may certainly benefit from behavioral modification and structured education; however, a growing body of research indicates that clinical outcomes can be substantially improved with the help of specific dietary and biochemical interventions that help reduce stress on the immune system while bolstering the detoxification mechanisms,” explains Dr. Pittman. “Many children also benefit greatly from the correction of gastrointestinal problems, heavy metal overload, brain inflammation, and nutrient deficiencies that are common in these children.”

The Carolina Center’s integrative approach to ASDs utilizes the DAN! protocol, which is aimed at reversing the underlying problems mentioned above, as well as addressing the unique biology of each child. Advanced registration is required in case of cancellation. To reserve your seat, contact the Carolina Center at (919) 571-4391 or via email at register@carolinacenter.com.

About The Carolina Center

The Carolina Center utilizes a combination of advanced complementary and alternative therapies, along with dietary and lifestyle modifications, to treat a wide variety of chronic illnesses and immune system dysfunctions. The primary goal is first and foremost to support the body’s ability to heal itself, while also addressing the underlying causes and changing the unique conditions that drive many diseases forward. Along with individually tailored nutritional and botanical regimens, the Center utilizes a number of innovative approaches, including Hyperbaric Oxygen Therapy, Colon Hydrotherapy, IV Glutathione, Cellular and Bioenergetic Testing, and various strategies for Biological Detoxification to help patients with chronic exposures to heavy metals, mold, parasites, and multiple chemicals. For more information, call (919) 571-4391 or visit www.carolinacenter.com.

Dr. Pittman is among the few physicians in North Carolina trained by the Autism Research Institute to deliver the Defeat Autism Now! Protocol. In July 2009, he participated in an intensive clinical training with Elizabeth Mumper, MD, who serves as Medical Director for the Autism Research Institute, and is President and CEO of The Rimland Center for Integrative Medicine in Lynchburg, VA. This training focused primarily on the DAN! approach to medical evaluation and treatment of children with Autism and ASDs.

NCTMB promotes integrative medicine at conference

The National Certification Board for Therapeutic Massage & Bodywork (NCBTMB) has announced it will be exhibiting at the Integrative Healthcare Symposium in New York City, Feb. 26 to 27, 2010.

As more and more Americans turn to complementary and integrative medicine for preventative and cost-effective care, NCBTMB seeks to play an active role in promoting the efficacy of massage therapy in our nation’s health and wellness. In fact, a 2008 National Center for Health Statistics report found that 38 percent of adults used one or more complementary and alternative medicine (CAM) therapies in the previous year. Of those CAM therapies, massage continues to rapidly gain acceptance. The number of Americans relying on the benefits of massage increased by 16 million from 1998 to 2008, according to a survey by the American Massage Therapy Association (AMTA).

At the Integrative Healthcare Symposium, NCBTMB will meet with educators, physicians, chiropractors, nurses, dieticians and other health-care practitioners to provide information about how massage is being incorporated into current medical models. NCBTMB is the only national massage and bodywork organization to exhibit at the symposium.

NCBTMB will also highlight some of the evidence-based research available on massage and its role in treatment plans; data that demonstrates the effectiveness of massage for patients experiencing pain, anxiety and/or depression due to cancer, psychological disorders, osteoarthritis, fibromyalgia and other conditions.

In addition, NCBTMB will provide ... information about its accredited exam programs. Representatives will explain that, by hiring national board certified therapists, employers are assured patients are treated by practitioners who are held to the highest ethics and standards in the profession.

Attendees are invited to stop by NCBTMB’s booth-–#511-– to enjoy a complimentary chair massage and engage in further discussions about the benefits of therapeutic massage and bodywork, to patients and health-care providers.

About NCBTMB

The National Certification Board for Therapeutic Massage & Bodywork (NCBTMB) was established in 1992 as an independent, private, nonprofit organization fostering the highest standards of ethical and professional practice in the delivery of therapeutic massage and bodywork through a recognized credentialing program. NCBTMB examinations are currently accepted or recognized in statute or rule by 37 states plus the District of Columbia. There are currently more than 90,000 professionals with NCBTMB certification. NCBTMB’s certification programs have been accredited by the National Commission for Certifying Agencies (NCCA).

NCBTMB will also provide updates about the new Advanced Certification initiative, which is well under way. “The creation of this credential is critical in elevating massage in the eyes of more conventional health-care providers who wish to incorporate an integrative approach to their practice,” said NCBTMB Chief Executive Officer Paul Lindamood. “Advanced Certification will identify massage therapists who strive for a higher level of education, experience and expertise, and may be better prepared and suited for an outcome-based setting.”

Our law firm has many successes with health care and business law clients, whose practices are transforming the business and health care landscape as we know it.

Michael also sponsors Being Central, a Portal for Potential, which gives access to other, pre-paid legal services.

Medical board discipline for complementary, alternative & integrative medical therapies

(Michael H. Cohen Attorney ) — Sat, 27 Feb 2010 14:55:25 -0500

Medical board discipline for complementary, alternative & integrative medical therapies is a concern our attorneys address when physicians integrate CAM into their practices and clinics.

Disciplinary provisions for "unprofessional conduct" or "professional conduct" vary by state.

Here is one analysis, which we conducted for a client located in Georgia. Of course, a similar approach, tailored to New York, California, Massachusetts, Oregon, Vermont, or any other state, could be conducted:

The disciplinary provisions allow the GCMB to discipline a physician for conduct including when the physician has:[1]

(6) Advertised for or solicited patients; obtained a fee or other thing of value on the representation that a manifestly incurable disease can be permanently cured; or made untruthful or improbable statements, or flamboyant or extravagant claims concerning his or her professional excellence or treatment protocols;

(7) Engaged in any unprofessional, unethical, deceptive, or deleterious conduct or practice harmful to the public, which conduct or practice need not have resulted in actual injury to any person. As used in this paragraph, the term "unprofessional conduct" shall include any departure from, or failure to conform to, the minimum standards of acceptable and prevailing medical practice and shall also include, but not be limited to, the prescribing or use of drugs, treatment, or diagnostic procedures which are detrimental to the patient as determined by the minimum standards of acceptable and prevailing medical practice or by rule of the board.[2]

The language in (6) certainly cautions against exaggerating claims concerning the benefits of CAM therapies. It is a good practice to have counsel review your website and any major changes in website language and advertising that will discuss functional or CAM methods.

More generally, the broad language in (7) concerning “any departure” from “minimum standards of acceptable and prevailing medical practice” allow the Board at their discretion to investigate and potentially impose discipline for nonstandard practices, be they the different diagnostic and treatment reasoning contained in functional medicine or complementary or alternative methods such as computer-based GSR devices such as NES. The risk of such intervention by the Board is greatest when a CAM therapy is used in lieu of conventional care.

This has been a long-standing issue for physicians practicing CAM in other states with statutes containing similar language. Historically, the issue came to a head with In re Guess,^{^[1]} a 1990 case decided by the North Carolina Supreme Court. Guess was an MD who used homeopathy as a last resort. The state medical board charged him with “unprofessional conduct” under a state statute defining the same as any departure from “standards of acceptable and prevailing medical practice in the state.” Even though patients testified at the medical board hearing that Guess had only helped them, and there was no evidence that he had ever harmed a patient, the Board revoked his licensed based on the statutory definition. After a trial and an appeal, the state Supreme Court upheld the revocation, noting that the statute allowed revocation without any showing of injury to a patient.[3]

Georgia has an “Access to Medical Treatment Act.”[4] This legislation provides:

(b) Notwithstanding any other provision of law, and except as provided in subsection (c) of this Code section, an individual shall have the right to be treated for any illness or disease which is potentially life threatening or chronically disabling by a person licensed to practice medicine under this article with any experimental or nonconventional medical treatment that such individual desires or the legal representative of such individual authorizes if such person licensed to practice medicine under this article has personally examined such individual and agrees to treat such individual.

treatment to an individual described in subsection (b) of this Code section if:

(1) There is no reasonable basis to conclude that the medical treatment itself, when administered as directed, poses an unreasonable and significant risk of danger to such individual; and

(2) The person licensed to practice medicine under this article has provided the patient with a written statement and an oral explanation, which the patient has acknowledged by the patient's signature or the signature of the patient's legal representative, that discloses the facts regarding the nature of the treatment, specifically including that the treatment offered is experimental or nonconventional, that the drug or medical device has not been approved by the Food and Drug Administration for any indication, as well as the material risks generally recognized by reasonably prudent physicians of such treatment's side effects.

(d) The treatment of patients in compliance with this Code section by a person licensed to practice medicine under this article shall not by itself constitute unprofessional practice or conduct.

Note that the carve-out the Act provides for CAM is limited to treating a patient “for any illness or disease which is potentially life threatening or chronically disabling.” This is a much more limited carve-out than, as noted, some other states provide for physicians using CAM.

Although medical boards in other states with similar statutes have deployed the “any departure” language against physicians who have integrated CAM therapies, such a broadly worded provision—together with Georgia’s narrow statutory carve-out—certainly does not mean that including CAM will lead to discipline. The language does, however, suggest caution. As we discussed in our conference call, the use of nonstandard diagnostic tests such as saliva-based horomonal work-ups or narrower reference ranges when interpreting tests such as TSH for the diagnosis of hypothyroidism can raise standard of care issues when they cross into areas for which the Board is not willing to allow for professional differences of opinion.

Judging the risk of adopting functional or CAM practices is an uncertain enterprise that ideally includes researching what methods have resulted in discipline in Georgia in the past, how the medical community views the method, whether the method is supported by a national organization that is able to issue CMEs for training in the method, the extent to which the method supplants a conventional method that is seen as well-established, the risks of the functional or CAM method and respective risks with any competing conventional approach, and the regulatory posture of FDA when relevant.

It is important to recognize that disciplinary cases are fact bound and rarely arise as a simple charge that a “forbidden” therapy is being done. Cases almost always involve the details of how the therapy was practiced, the quality of the medical reasoning and decision making in a number of cases as well as the quality of the record keeping. Two physicians could incorporate a given CAM therapy into that practice and one never have any difficulty and the other be disciplined, because one may practice good medicine and use the therapy as as energetic adjunct while the other wanders into its use in clinical decision making.

With regard to the nonconventional nature of these therapies, however, in the context of malpractice defense, there is a legal defense to medical malpractice known as the “respectable minority” doctrine. The rule essentially states that a physician who undertakes a mode of treatment that a respectable minority within the profession would undertake under similar circumstances, does not incur liability for negligence merely because the physician substituted such an approach for the more generally approved one.

While one could argue that functional medicine has garnered such a respectable minority, this does not necessarily apply to the Board, which has significant leeway to set standards of care. In other words, “respectable minority” is a defense to a medical practice action, but in a disciplinary case, the medical board may or may not respect a standard of care deviation based on the existence of such a professional minority viewpoint. At the same time, however, that a functional approach at issue is taught at conferences sponsored by such respectable minority organizations, such as the American College for Advancement in Medicine or the Institute for Functional Medicine is useful. Collecting CME credits for functional approaches of interest is an important defensive consideration, as the granting of credits for course content that includes a questioned therapy is valuable evidence that at there is some recognition of the therapy.

[1]O.C.G.A. § 43-34-8. The Board Rules contain still other rules governing physician practices. For example, physicians must post a declaration of the patient’s rights to file a grievance with the Board concerning a physician, staff, office or treatment received. Rule 350-27-.02 (See Appendix 1).

[2] Similarly, Rule 360-3-.02 (defining unprofessional conduct) includes the following: (18) Any other practice determined to be below the minimal standards of acceptable and prevailing practice.

[3] North Carolina voters reacted to the decision, and in 1993, North Carolina enacted a “medical freedom” law, providing that the Board cannot revoke a physician’s license “solely” because the physician practices a therapy “that is experimental, nontraditional, or that departs from acceptable and prevailing medical practices,” unless the Board can establish that the treatment is either ineffective, or, more dangerous that the prevailing conventional therapy.^{^[3]}

This kind of statute, replicated in various forms in other states, provides “medical freedom” (or at least expanded health care choices) to the patient by granting the physician some leeway to incorporate CAM therapies without that the medical board will initiate disciplinary proceedings “solely” because of including CAM. There were numerous efforts to bring similar bills into law on the federal level—notably through introduction in 1995 of the federal Access to Medical Treatment Act—but such efforts failed.

[4] O.C.G.A. § 43-34-38.

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The Monk Who Telegraphed the Fullness in Emptiness Story

(Michael H. Cohen Attorney ) — Tue, 23 Feb 2010 00:21:54 -0500

It was in Iowa City that I really opened to meditation.

This is an excerpt from A Friend of All Faiths.

∞ ∞ ∞

The Monk presided in a second-story classroom in the Universalist Church, directly below the makeshift yoga studio. Like me, he too had only been in Iowa City two days earlier. There the resemblance ended.

I had long hair; rebelling against Wall Street, and reveling in my newfound freedom as a student again, at the Iowa Writers’ Workshop—I had eighteen months to study creative writing before returning to the law firm where I had interned as a summer associate—I wore my hair down to the shoulders, and shaved intermittently, just enough to keep a little “grunge.” The Monk was, of course, clean-shaven, including his scalp, and wore the familiar robes of the Tibetan order. I fidgeted, my knees crammed into a self-imposed pretzel prison—perhaps mirroring the prison of thought. The monk, sent by the Dalai Lama from his monastery-in-exile in India, sat cross-legged on an octagonal, purple cushion, looking airy and light, and entirely content in front of the room.

For the first hour he lectured, using the few words of English he had learned on the plane. “Space … sky … no mind.” His pronunciation made the words difficult to understand; he said “I-guy,” for example, instead of “sky.” His voice flowed in a soft, soothing monotone. “No self. Self illusion. Maya.” He seemed quite insistent on this point. I strained to catch the thread of ideas. “Clouds,” he continued. “Clouds. Go, come.” He emphasized this again: “Go, come.” What did this mean?

I adjusted the cross of my legs, the cross of discomfort; the cramps in my calves were becoming unbearable. The Bulgarian professor, ahead of me sat upright, a serene smile floating on his face, or so I imagined. He apparently understood “go, come.” I had no clue. Perhaps it was the command one would give to a dog—the mongrel monkey mind, no doubt, wandering hither and thither. But this meta-commentary did no good, I supposed: I was supposed to seek Higher Awareness.

The Monk continued: “Nothing … is.”

Suddenly his eyes bored into mine, as if to illuminate the message. “Nothing is,” I repeated to myself over and over, hoping for a revelation. I looked at him and slightly raised my eyebrows, as if to say, “I appreciate your teaching, but I don’t get it.” He smiled, and held the silence, as if the message could penetrate through the gaze. Nothing is? I wondered. Existential philosophy? Zen-like contradiction?

“Not self … and yet Self.” Again, he looked past the Bulgarian’s eyes and into mine—maybe something hidden in him, some secret teaching, wafted across the airwaves, riding a wave of light. Einstein had invented relativity by such flights of fancy, and perhaps in the recesses of Being, I too—whomever “I” was—would inherit a more deeply relative, and hence truthful, personal perception of space and time, and the epistemological equivalent of Einstein’s objective revelation would take root in my subjective soul.

Clouds go, clouds come; nothing is; no self; what did it mean?

I relaxed a little as I noticed people around me closing their eyes. The room was so hot. Stifling so: my head, bobbing up and down; a recognizable word, here and there, mixed with Tibetan. No self, and yet Self. Searching vainly for English translation; beyond the window, overgrown cornfields; the Bulgarian, transfixed with a smile.

“Now meditate.”

The command floated in from somewhere beyond the cornfields: it was the Monk’s voice yet not the Monk’s voice; the command of his master, the Dalai Lama, supposedly (allegedly, we lawyers would disclaim) an embodiment of the Buddha—or a luminescent relative thereof; yet not the Dalai Lama; it came from India yet via Iowa; it came and went, like the clouds, into space, into sky, into the no-mind that my mind had become. More and more receptive to the truth—to the freedom that lay beyond the cave of the mind, the thought-forms that attached and melded to Maya (the illusion) like wild subatomic particles searching desperately for a spin-compatible partner.

The instructions wafted in, pleasantly. “Inhale white; exhale black. Inhale white; exhale black.”

My head bobbing; the Monk’s face came into focus. The face posed before my closed gaze—a form of my own face: the koan, what was the face you wore before you were born? He was: Calm, steady, clear-eyed, shaven, a bright contentment. Head floating in air, the face before faces existed. “Space, sky, no mind, no self.” Thoughts came and drifted like clouds in the sky. “Illusion.”

Behind the thoughts, an awareness. A Presence. My Self? No self! Deeper in.

Soon, the eyes opened, returned to a condition known in common parlance as being “awake.” And it had been made into such a metaphor, this thing called wakefulness. The problem remained: could one be awakened, yet still asleep? Intellectually, the Monk’s broken English made no sense, gave no lasting theology, offered no cosmology I could fathom. The teachings I could learn from the Bulgarian professor, but there was not enough to grab onto. Yet as I was walking through Iowa City the day after the meditation, something had shifted. My brain was different after the experience. I was engaged in ordinary activities: walking, talking, shopping, yet somehow had the added dimension of seeing deeply into people, behind the mask of language and social pleasantry. I was reading emotions viscerally—and sometimes in the form of symbolic information. Sometimes creative energies literally created shiny sparks around people; in other cases, spirits of fear, greed and lust seemed to speak through those huddled around a table. I also found these things in myself, seeing the oneness of humanity in the ways others were reflecting my own self.

One of my first workshop classes: many classmates looked like hungry, devouring ghosts: these were the energies I saw through them, behind the shell. Real demons leaped out and sucked their energies into dimensions of anger, sadness, and pain. Had the Monk transmitted something, non-verbally but nonetheless palpably? Or were these my own ghosts of anger and resentment, mere projections of hidden shadows? Then again, if he had left some of himself in me, or of the Dalai Lama, and I had no self and he had no self, then who had transmitted what to whom? And what did one monk say to another in the cave of silence?

Cognitively, I had no explanation; yet my whole phenomenological sense of reality had shifted.

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Liz and Michael's Fabulous Invite

(Michael H. Cohen Attorney ) — Mon, 22 Feb 2010 15:04:23 -0500

Below is our amazing invite - don't miss it - this could change your life!

Do you plan to stay at your job for the rest of your life? (That sounds SOOO depressing). Is it worth 1/2 hour of your time to hear from someone who in a very short while left her job for six figures of PASSIVE income? She is totally free and can help show you how to duplicate her success.

I earn a great, passionate living as an attorney. Why am I taking time out of my day to do this side business?

Come find out. Repeat after me: can you say, RESIDUAL? Say it in front of a mirror. Go ahead ... try it! Then call in on Wednesday Feb 24 at 2 pm PST: 218-844-0850, Pin # 825163.

PS: How do you spell Residual?

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PS: No income or earnings claims, guarantees or promises are made in this announcement. This is strictly an invitation to a phone call.

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Energy healing on the rise

(Michael H. Cohen Attorney ) — Mon, 22 Feb 2010 14:29:46 -0500

Forget guns, germs and warfare and welcome to health, wholeness and healing.

Maryland profiles a new healer:

Disease has always been with us, but modern, Western medicine is only a few hundred years old.

Before germ theory and pharmaceutical research, the human race devised countless strategies to relieve pain, banish illness and prolong life.

Southern Marylanders are keeping a few of these ancient disciplines alive, insisting they have much to teach us, even in a scientific age.

Energy flow

Janet Hall is perhaps a complementary medicine polymath. She teaches all 13 courses in "natural health and healing" offered by the College of Southern Maryland's continuing education program, as well as a course in "inspirational walkabouts." She operates Overhall Consulting out of her Port Republic home, where she has a massage table in her basement for Reiki and other therapies.

"I love it, sharing my knowledge and experience with alternative and complementary medicine. I love doing healing work because it's amazing. The energy we can transmit through our hands, we transmit from the universe," Hall said recently as a grizzled retriever-mix dog twitched and snored on the floor of her studio. "The person receiving healing work is really the healer. We're just a conduit."

Energy therapies can differ in their particulars, but practitioners trace their origin to concepts in traditional East Asian and Indian medicine, especially the Chinese idea of "qi," roughly meaning life-force, that is said to permeate all human beings, and the ancient Indian belief in "chakras," seven energy centers located along the spine.

Reiki, a Japanese energy-balancing technique, was the first that Hall learned. It captivated her, leading her to study spiritual energy disciplines founded in the United States, including Quantum Touch. Hall said she found it useful for everything from nasal congestion to post-traumatic stress disorder. Eden Energy Medicine, in which she is certified to work, focuses on seven of the human body's eight "energy systems." Emotional Freedom Tapping teaches clients to touch different parts of the body with their fingers to tap away anxiety, cravings and trauma. As a "raindrop" practitioner, she rubs essential oils in at points along a client's spine, a process she says causes the person to gain up to an inch in height.

Hall stresses that she is not a medical practitioner. Three years ago she was ordained as a minister to get added legal protection for her work, she said. Consulting a certificate, she said she is a minister of The Sanctuary of the Beloved, Order of Melchizedek, based in New York.

Our law firm has many successes with health care and business law clients, whose practices are transforming the business and health care landscape as we know it.

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Combine homeopathy and acupuncture and what do you get?

(Michael H. Cohen Attorney ) — Mon, 22 Feb 2010 12:30:12 -0500

The answer: homeopuncture.

Two worlds come together

Homeopuncture is a new treatment strategy slowly coming into vogue in integrative medical clinics around the world which combines two alternative medical therapies, Acupuncture and Homeopathy into one. Each of these age old therapies predate conventional medicine by a long shot and are used around the world to treat everything from the most simple to the most complex health challenges. Both also have growing bodies of research proving their effectiveness in treating a large variety of illnesses, acute as well as chronic. This in spite of the large challenges that alternative medicine has to face in the research arena which includes lack of funding, and the relative complexity in designing research studies to study these modalities. This compared to the relatively simple process of studying single drugs for a single symptoms as is done on a large scale in conventional medicine.

Homeopathy

This form of medicine has been around for over 200 years and is based on the basic principle which is that “like cures like” also know as the “law of similars”. In other words a substance that would cause specific symptoms when taken in its raw form, will alleviate those same symptoms if the compound is diluted and succussed. Through a series dilutions and succusions the remedy is “potentized” to a level at which it is capable of reversing these symptoms even if the symptoms are not caused by the substance but in stead are related to an illness.

Homeopathy was founded by a German physician Dr. Samuel Hahnemann (1755 –1843) who began practicing as a doctor in 1781 and interestingly enough stopped practicing medicine shortly after he got married because the medicine of his day he felt caused more harm than good.

In his own words: “My sense of duty would not easily allow me to treat the unknown pathological state of my suffering brethren with these unknown medicines. The thought of becoming in this way a murderer or malefactor towards the life of my fellow human beings was most terrible to me, so terrible and disturbing that I wholly gave up my practice in the first years of my married life and occupied myself solely with chemistry and writing.”

After a few years in self imposed exile from medicine he made an interesting discovery that he could reverse the toxic effects of a substance like Cinchona, the bark of a peruvian tree, which causes symptoms exactly like that of malaria, by taking a diluted and potentized version of it. This became the first homeopathic remedy. He also discovered subsequently that he could do exactly the same with other toxic substances. What is most fascinating as that he did the first experiments on himself with his wife standing at the ready with the antidote. These experiments were called provings. Dr. Hahnemann was the one who coined the term homeopathy and wrote the first textbooks on homeopathy called the “Materia Medica”

The biggest difference between homeopathy and conventional medicine is that rather than focusing on symptoms of disease and their treatment with synthetic medicines or the treatment of disease causing organisms, homeopathy works to eliminate the imbalance that allows for symptoms of disease to develop or for disease causing organisms to proliferate.

Acupuncture

Acupuncture in the West is often thought of as a new form of alterative medicine but in reality it is over 5,000 years old and originated in China. Very basically, Acupuncture is the insertion of very fine needles, (sometimes in conjunction with electrical stimulus), on the body’s surface, in order to influence physiological functioning of the body. The ancient Chinese believed that there is a universal life energy called Chi or Qi present in every living creature. This energy is said to circulate throughout the body along specific pathways that are called meridians. As long as this energy flows freely throughout the meridians, health is maintained, but once the flow of energy is blocked, the system is disrupted and pain and illness occur. Acupuncture works to “re-program” and restore normal functions by stimulating certain points on the meridians in order to free up the Chi energy. In other words it helps to restore balance between the Yin and Yang energies.

There are fourteen main meridians running vertically up and down the surface of the body. There are six organ Meridians in each half of the body (12 total) and two unpaired midline Meridians. The acupuncture points are specific locations where the Meridians come to the surface of the skin, and are easily accessible by “needling,” Moxibustion, Acupressure or Homeopuncture. The connections between them ensure that there is even circulation of Qi throughout the body and a balance between Yin and Yang. Qi is comprised of two parts, Yin and Yang. Yin and Yang are opposite forces, that when balanced, work together to optimize health.

Other modalities used in conjunction with Acupuncture

Acupuncturists employ different needle insertion techniques and different types of needles to stimulate specific acupuncture points selected based on the ailments or symptoms that a patient presents with. There are also related procedures that are used in conjunction with acupuncture to enhance the effect: for example electro-acupuncture where very small electric impulses are applies through acupuncture needles or directly to the acupuncture points without needles. A laser can be used in a similar way which may obviate the need for needle insertion but may be a little weaker than needling or electroacupuncture.

Auriculotherapy or Ear Acupuncture has become very popular in the U.S. and is often used in place of regular acupuncture points on the rest of the body. The ear is very rich in nerve endings and almost the entire body is represented through acupuncture points on the ear. Auricular Acupuncture has been successfully used in treating problems ranging from chronic pain just about anywhere in the body to obesity to smoking cessation and drug and alcohol abuse.

There are numerous studies done both in the U.S. and abroad that show that acupuncture and auriculotherapy are both effective in the treatment of numerous ailments and symptoms. Some of the best studies were done on chronic pain conditions such as chronic low back pain, carpal tunnel syndrome, and headaches; as well as on other common symptoms like nausea associated with chemotherapy. There also currently a whole slew of other studies on acupuncture that are currently under way which will shed further light on its efficacy.

Homeopathy and Acupuncture

Both modalities of treatment can be combined and delivered in their original form to complement each other by practitioners trained in both arts.

Homeosiniatry

Homeopaths Weihe (of German descent) and Goehrum discovered that when certain diseases were cured by a homeopathic remedy, a point in the body that grew tender with pressure was relieved. During his research, Weihe was able to locate approximately 197 points. He also linked these points with particular homeopathic remedies which were prescribed for a specific disorder. He was able to use the points to confirm the correct remedy to prescribe when in doubt. This was known as Homeosiniatry. Strangely enough, these tender points are also described in TCM as Alarm points and As-shi points. Alarm points represent organs in the body. If there is a disorder in the organ’s related energy channel, the respective alarm point will become tender.

Homeopuncture

Subsequently, a famous French author and acupuncturist, Roger de la Fuye (French Homeopath and Acupuncturist) researched and concluded that homeopathy can be used with acupuncture to treat patients. He was also able to utilize the points to confirm if the remedy was the proper one.

Considering the effectiveness of each therapy, it is fair to say that combining these two therapies could be very fruitful.

Homeopuncture in Practice

Using homeopathy with acupuncture has brought about a union of the knowledge between the healing methods of acupuncture and homeopathy. Both treatment methodologies have shown their value in treating many disorders, and so in combination they can make possible even greater feats.

If an acupuncturist were to say “why bother… acupuncture can do anything”, this would only indicate ideological rigidity, and they would have failed to see that the idea of any treatment is to heal the patient as soon as possible and as effectively as possible. In combining the knowledge of the two systems, we become equipped to have a better understanding about the patient and the illness. This enables practitioners to treat patients more efficiently.

Clinical Homeopuncture

In recent years, the combination of acupuncture and homeopathy has revealed success in treating conditions that range from alopecia areata (hair loss) and skin disorders, such as leucoderma (Vitiligo) and psoriasis, to arthritis and many other conditions.

The Procedure

The needles are immersed in a liquid homeopathy remedy. The acupuncturist uses normal needling, or non-retention needling (in disorders that cover a greater area), on the affected area (in Chinese ‘Ashi points’). ‘Non-retention needling’ is the use of acupuncture needles to puncture the skin and then removing it, instead of letting the needle remain in the skin as it normally would be. This is continued until the affected area has been completely pricked with the needle. After every one or two pricks, the homeopath lubricates the needle tip before puncturing the skin again. This might sound very painful, but in fact if you go to an experienced acupuncturist you will experience no pain or minimal discomfort, depending on the location being needled.

Our law firm has many successes with health care and business law clients, whose practices are transforming the business and health care landscape as we know it.

Michael also sponsors Being Central, a Portal for Potential, which gives access to other, pre-paid legal services.

Bio-identical hormones make a splash

(Michael H. Cohen Attorney ) — Mon, 22 Feb 2010 12:26:11 -0500

Our law office routinely advises physicians and other health care clients regarding consent forms and legal issues surrounding bio-identical hormones and functional medicine.

Here is a news flash about use of bioidentical hormones in practice.

Dr. Rashmi Gulati of Patients Medical in New York Uses Natural Bioidentical Hormones To Relieve Spring's Hormonal Imbalances

NEW YORK, Feb. 18 /PRNewswire/ -- Patients Medical, a leading integrative and holistic medicine center in New York City, offers cutting-edge Bioidentical Hormone Replacement Therapy (BHRT) to help women transition from winter to spring when hormonal modulations are especially high. Rashmi Gulati, MD, Medical Director of Patients Medical and a trained holistic physician with the American College for Advancement of Medicine, helps women gain relief from Seasonal Affective Disorder (SAD) through individualized bioidentical hormone treatments.

Seasonal Affective Disorder (SAD), caused by hormonal imbalances in the brain, has especially high rates in early spring. "A lot of women think they are depressed, or don't understand why they are gaining weight. These women experience anger, lose their sex drive, and find it difficult to sleep. What they don't know is that these symptoms are caused by an imbalance with their estrogen and progesterone." Through BHRT, Dr. Gulati is able to bring stability and balance back to the lives of women.

Bioidentical hormones are the best option to treat hormonal imbalances because they are identical to your body's natural hormones. "They are made from natural substances such as soy and yams," explains Dr. Gulati. "The molecular structure of bioidentical hormones replicates human hormones, unlike pharmaceutical hormones, which are made from substances that may break down into carcinogen-forming products that our bodies are unable to eliminate."

At Patients Medical, Dr. Gulati makes sure that each client receives individualized care. After a detailed consultation, which may include blood tests as well as saliva and urine samples, Dr. Gulati analyzes the results to see if hormones are balanced. The patient is then put on a varied regimen of supplements, nutrients, IV therapy, and bioidentical hormones, which is tailored specifically for each person's needs. Dr. Gulati notes, "We do not treat the numbers. The goal is to treat the whole person and achieve optimum health to prevent diseases before they occur."

With over 15 years of experience, Dr. Rashmi Gulati is a leader in internal and integrative medicine. By combining Eastern and Western medicine, Dr. Gulati is able to provide patients with a complete balance in care. Through the treatment of bioidentical hormones, Dr. Gulati aims to improve overall well-being and increase the quality of life for her patients.

About Patients Medical

Patients Medical is a unique integrative medicine center in New York that combines the best of traditional and holistic medicine with modern technology to provide comprehensive care. Established in 1974, the center employs a multi-disciplinary staff including Board Certified Internists, Cardiologists, Gynecologists, Osteopaths, Nutritionists and many other holistic practitioners. The practice specializes in diagnosing the root cause of an ailment using cutting-edge technology, then healing the whole person with personalized protocols that draw upon both Eastern and Western medicine. Patients Medical offers free Bioidentical Hormone Seminars each month. Register by phone or email: 212-679-9667 x110 or Signup@patientsmedical.com.

Our law firm has many successes with health care and business law clients, whose practices are transforming the business and health care landscape as we know it.

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American Association for Integrative Medicine (AAIM) educates and certifies practitioners in the integration of Eastern and Western medicine

(Michael H. Cohen Attorney ) — Mon, 22 Feb 2010 11:59:55 -0500

The American Association of Integrative Medicine calls itself "the medical society for the 21st century."

The American Association of Integrative Medicine, the medical society for the 21st century, has announced that its widely-received flagship periodical, the Journal of the American Association of Integrative Medicine, will become a print publication starting with its spring 2010 issue. Its mission is to provide a forum for integrative medicine professionals through articles, research, opinion pieces and news.

“Most magazines today are going from print to online rather than the other way around,” said Dr. Zhaoming Chen, chief spokesman and executive board chairman for the American Association of Integrative Medicine (AAIM). “We are doing the opposite because of tremendous, increased demand in the healthcare industry for integrative medicine information.”

To date, there are only a handful of publications worldwide that are dedicated to bridging the gap between alternative and traditional medicine. The Journal of the American Association of Integrative Medicine originally made its debut in 2007 as an online publication and has since achieved worldwide distribution. With this change in format, the journal will now be accepting advertising from related companies. It will continue to accept article contributions from complementary and alternative medicine (CAM) providers.

About the American Association for Integrative Medicine

Founded in 2000 and headquartered in Springfield, Missouri, the American Association for Integrative Medicine (AAIM) educates and certifies practitioners in the integration of Eastern and Western medicine with the goal of improving clinical outcomes for patients. For consumers, they provide information and education about the benefits of integrative health care, as well as a careful selection of trusted providers. For health-care providers, AAIM promotes their high standards of professional competence to consumers and provides a gathering place for like-minded individuals who are committed to preserving global indigenous therapies and evaluating new approaches. They have thousands of members worldwide representing more than 22 medical specialties. For more information, visit www.aaimedicine.com.

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Our law firm has many successes with health care and business law clients, whose practices are transforming the business and health care landscape as we know it.

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The Mall Model: A Legal Structure to Handle Anti-Kickback Concerns of Integrative Care Centers

(Michael H. Cohen Attorney ) — Sun, 14 Feb 2010 16:50:48 -0500

Our law office has developed several business structures to address self-referral (Stark), fee-splitting and anti-kickback concerns in the integrative care center.

In the "Mall Model," the medical doctor owns a professional medical corporation (in some states it may simply be a professional corporation (“PC”) composed solely of physicians), and the Center is an incorporated entity (i.e., corporation or LLC) apart from the PC.

In the Mall Model, the Center essentially has a series of ‘storefronts’ consisting of the various independent practices. Each practice owns its patient records, and the Center cannot interfere with practitioners’ independent judgment.

The Center leases space to its storefront, practice tenants, and in turn charges for services typical of a medical services organization (“MSO”), such as front desk and marketing. The flow of payments is as follows:

· The patient renders payment to the individual practice.

· The practice pays the Center for MSO services.

· The practice also pays the Center under the lease.

The Center may collect patient payments on behalf of the practice, deposit these as agent to the practice’s account, and withdraw funds from the account to pay for its MSO services.

In the typical Mall Model, in addition to the lease arrangement:

· The patient renders payment to the individual practice.

· The practice pays the Center for MSO services (i.e., you both share the cost according to use at fair market value).

One could argue that with the Mall Model, there is no kickback, because no practitioner (nor the Center) receives compensation (in any form) in exchange for referring patients to either the Center itself and/or to other practitioners in the Center.

The Mall Model, if structured correctly, does not create any direct or indirect compensation in exchange for such referrals. But even were regulators to find the existence of a kickback, presumably the Rental of Office Space safe harbor would be available. Under this safe harbor, compensation must be reasonable, fair market value, based on arms-length negotiations, usual and customary rates for monthly charges without inflated hourly charges, and commercially reasonable, and not based on volume or value of referrals. However, the safe harbor requires an initial contract period of at least a year. [1]

[1] To meet this requirement under the similar exception under Stark, if an arrangement is terminated during the term with or without cause, the parties may not enter into the same or substantially the same arrangement during the first year of the original term of the arrangement.. 42 CFR 411.355(d).

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Our law firm has many successes with health care and business law clients, whose practices are transforming the business and health care landscape as we know it.

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When Integrative Medicine Physicians Sell Dietary Supplements: Legal Issues

(Michael H. Cohen Attorney ) — Sun, 14 Feb 2010 16:41:13 -0500

Serious legal issues can arise when physicians and CAM practitioners sell dietary supplements.

In 1998, the AMA adopted an “Ethical Position Against In-Office Sales of Health-Related Products:”[1]

In-office sale of health-related products by physicians presents a financial conflict of interest, risks placing undue pressure on the patient, and threatens to erode patient trust and the primary obligation of physicians to serve the interest of their patients before their own. When these items offer some health-related benefits the physician's influence over the sale is amplified and makes it even more necessary to place limits on such activities.

1. Physicians who do sell health related products from their offices should not sell any health-related good whose claims of benefit lack scientific validity. Physicians should rely on peer-reviewed literature and other unbiased scientific sources that review evidence in a sound, systematic fashion when judging the efficaciousness of the product.

2. Physicians who sell health-related products from their offices should follow these guidelines to limit their conflicts of interest minimize the risk of brand endorsement, and ensure a focus on benefits to patients.

a). Physicians may distribute health-related products to their patients free of charge or at cost, in order to make useful products readily available to their patients. When health-related products are offered free or at cost, it removes the elements of personal gain and financial conflicts of interest that may interfere, or appear to interfere, with the physician's independent medical judgment.

b). Except under certain circumstances, such as those described in Opinion 8.032, “Conflict of Interest: Physician Ownership of Medical Facilities,” physicians should not sell a health-related good when patients can obtain a product that offers the same medical benefit at a local pharmacy or health-products store.

3. Physicians should not participate in exclusive distributorship of health-related products, in which the products are available only through physicians' offices and for which product there is no comparable alternative available at a local pharmacy or health-products store. Physicians should manufacturers to make their products more widely accessible to patients.

In addition, the Model Guidelines for the Use of Complementary and Alternative Therapies in Medical Practice issued by the State Federation of Medical Boards state:

6. Sale of Goods from Physician Offices
Due to the potential for patient exploitation, physicians should not sell, rent or lease health-related products
or engage in exclusive distributorships and/or personal branding;
• Physicians should provide a disclosure statement with the sale of any goods, informing patients of
their financial interest; and
• Physicians may distribute products to patients free of charge or at cost in order to make products
readily available.
• Exceptions should be made for the sale of durable medical goods essential to the patient’s care, as
well as nonhealth-related goods associated with a charitable or service organization. [Language
on the sale of goods from physician offices is contained in the report of the Special Committee on
Professional Conduct and Ethics as adopted in April 2000.]

[1] Council on Ethical and Judicial Affairs, American Medical Association. Sale of non health-related goods from physicians' offices. JAMA. 1998;280:563. Opinion 8.063. Many state medical boards have adopted the guideline, giving it the force of regulation.

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Our law firm has many successes with health care and business law clients, whose practices are transforming the business and health care landscape as we know it.

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Federal Self-Referral (Stark) and Anti-Kickback Analysis for Integrative Care Centers

(Michael H. Cohen Attorney ) — Sun, 14 Feb 2010 16:06:15 -0500

Any multidisciplinary physician practice or group practice (including practices including CAM practitioners in integrative care centers) should be reviewed by an attorney for self-referral and kickback concerns.

Self-Referral

So-called “self-referral” involves referring to an entity in which the practitioner has a financial interest.

More specifically, under federal law, the self-referral law, now codified at 42 CFR section 411.353 (“prohibition on certain referrals by physicians and limitations on billing”), also known as “Stark” after its original proponent, Congressman Pete Stark:

(1) Prohibits a physician from referring patients for certain “designated health services” (DHS) payable by Medicare, to an entity in which the physician (or an immediate family member) has a financial (ownership or compensation) relationship,[1] unless an exception applies.

(2) Prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third party payer) for those referred services.

Penalties for violating Stark include denial of payment, refund of payment, imposition of a $15,000 per service civil monetary penalty and a $100,000 civil penalty for each illegal arrangement.

DHS include the following services when payable, in whole or in part, by Medicare:[2]

· clinical laboratory services;

· physical therapy services;

· occupational therapy services;

· radiology services (including MRI, CT scans, ultrasound services, and nuclear medicine);

· radiation therapy services and supplies; durable medical equipment and supplies;

· parenteral and enteral nutrients, equipment and supplies;

· prosthetics, orthotics, and prosthetic devices and supplies;

· home health services;

· outpatient prescription drugs; and

· inpatient and outpatient hospitalization services.

To the extent the Center does not offer DHS, the federal self-referral law is inapplicable.

Federal Anti-Kickback Law

The federal anti-kickback law[3] states that whoever knowingly and willfully receives or pays anything of value to influence the referral of federal health care program business, including Medicare and Medicaid, can be held accountable for a felony.

Stark and anti-kickback can concerns potentially can overlap whenever compensation arrangements involve a physician interest in the entity receiving or giving referrals. However, federal anti-kickback is broader than Stark in two respects:

· The term “whoever” means that unlike Stark, the anti-kickback statute applies to all practitioners, not just “physicians” (so long as the referral is regarding health care services that involve reimbursement under a federal insurance program, such as Medicare, CHAMPUS, or federal employee benefits).

· While Stark only applies to DHS, the anti-kickback law applies to health services beyond those designated in Stark.

The Federal Anti-Kickback Statute incurs a criminal violation charge because by definition it requires a specific intent to induce referrals or orders for services. Anti-Kickback violations are punishable by up to five years in prison, with the potential for additional criminal fines up to $25,000, and administrative civil money penalties reaching as much as $50,000.[4] Additionally, the OIG may commence administrative proceedings to prohibit anyone convicted of an anti-kickback violation from participation in federal and state health care programs or impose civil monetary penalties for fraud, kickbacks, and other prohibited activities.[5]

According to HHS, some of the activities that may violate anti-kickback rules include:

· Advertising or marketing activities on behalf of health care providers

· Impressions, page views, or eyeballs, e.g., the number of times that an advertisement is served to a viewer.

· Click-throughs (e.g., when a viewer of an advertisement clicks through to the vendor).

· Joint promotion agreements, in which more than one company promotes their projects together.

· Sponsorships.

· Slotting fees, e.g., payments for a position on a list of vendors.

· Strategic Alliances between hospitals and physicians or between group practices.

· Technology and Content Licensing

· Affiliate Programs (e.g., referral programs on a revenue sharing basis or a percentage of sales resulting from placement of the advertisement? One method of kickback marketing relies on the sharing of customers between websites that are affiliated as they pass the customer back and forth).

· Sale of Product or Services

· Are free products and services offered to encourage their use?

· Are there up-sells to other products and services, e.g., offering a free baseline or starter service or product, and charging for subsequent or add-on services or products?

· Are there fees to participate in a network of preferred providers?

· Are services or products offered for free or at a discount, if other, "full price" products are purchased as a bundle?

· Publishing Content

· Does the publication in question charge companies exorbitant fees for article reprints? If so, it may be publishing content just to sell reprints back to the company covered in the story.

· Subscription fees? Some media companies ask for "scheduling fees" or "subscription fees" to provide editorial coverage to companies. They might get paid $500 for an article, $5,000 for an audio interview, or even $20,000 for a video segment.

· Advertising revenue (see above)

In response to the concern that some commercial arrangements would be innocuous or beneficial even if technically afoul of anti-kickback prohibitions, the Office of Inspector General (OIG) published thirteen regulatory “safe harbors” in 1991-2. The OIG subsequently clarified these and added new safe harbors for various arrangements. Some of the major safe harbors[6] include:

· investments in large publicly held health care companies;

· investments in small health care joint ventures;

· space rental;

· equipment rental;

· personal services and management contracts;

· sales of retiring physicians' practices to other physicians;

· referral services;

· warranties;

· discounts;

· employee compensation;

· group purchasing organizations;

· waivers of Medicare Part A inpatient cost-sharing amounts;

· certain practices in managed care settings.

The safe harbors of particular interest to integrative care practices are:

· investment in group practices

· space and equipment rental

· bona fide employees

· personal services and management contracts

With respect to federal anti-kickback law in the Integrative Care center, we can ask the following questions:

· Does the physician (or other health care practitioner) receive compensation (in any form) in exchange for referring patients to the Center itself and/or to other practitioners in the Center?

· Similarly, does the Center receive compensation (in any form) from the physician (or other health care practitioner) in exchange for referring patients to the physician (or other health care practitioner)?

If the answer to either question is “yes,” then there is may be at least a technical violation of the kickback rules.

Suppose, for example, that the patient makes the check out to the naturopathic physician, and then the naturopathic physician remits a percentage of that payment to the Center, ostensibly in compensation for administrative services. The mere fact that payment flows from the patient to the practitioner, and then from the practitioner to the Center, could raise a concern that the Center is receiving compensation in exchange for referring patients to the naturopathic physician.

In other words, if the arrangement is structured so that patients are making the check out to the physician (or other health care practitioner), and the practitioner then remits payment to the Center, this could be regarded as a “kickback” or illegal remuneration to the Center. This is the way many integrative centers structure their operation prior to contacting us.

As suggested, the Center should be able to rely on:

· the investments in group practices safe harbor if the group meets the Stark law definition of group practice. The requirements of this definition have some limitations for integrative care centers.

· the rental safe harbor if it meets the rental of office space exception under Stark.

· The bona fide employment relationship safe harbor if it meets the bona fide employment relationship exception under Stark.

· The personal service and management contracts safe harbor if it meets the personal services arrangements exception under Stark.

These are complex provisions of law that we describe elsewhere.

In addition, state law should be analyzed to see whether state prohibitions on self-referral, kickbacks, and fee-splitting apply.

[1] For purposes of determining whether a physician has a direct or indirect financial relationship with a DHS entity to which the physician refers, the physician will “stand in the shoes” of the physician organization. 42 CFR 411.351 and 354. Under Stark II the physician organization referred to the physician’s professional medical corporation; under Stark III the physician organization includes the group practice. Wachler & Dresevic, Stark II Phase III: “The Full Picture,” The Health Lawyer (ABA, September 2007), p. 12.

[2] The original statute (Stark I) only prohibited referrals for laboratory services; Stark II expanded the prohibition to the list of designated health services. Somewhat confusingly, the Health Care Financing Administration (“HCFA”) issued final regulations for Stark II in two phases (“Phase I” and “Phase II”), and then on September 5, 2007, the Centers for Medicare and Medicaid Services (“CMS”)—the federal agency that administers Medicare and Medicaid—issued “Phase III” of the final Stark II regulations at 72 Fed. Reg. 51012 (2007). Phase III republished the entire Stark regulatory text (except for portions relating to advisory opinions). Wachler & Dresevic, p. 3. In addition, the 1996 Health Insurance Portability and Accountability Act (HIPAA) mandated that the OIG furnish advisory opinions to requesting providers seeking guidance on whether a proposed arrangement violates the law.

[3] 42 U.S.C. 1320a-7b(b). See Appendix 3 for the statutory definition.

[4] 42 U.S.C. 1320a-7b(b).

[5] There is helpful reference material on Stark and anti-kickback law by the Legislation and Regulation by the HHS Agency for Healthcare Research.

[6] 42 CFR 1001.952.

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Our law firm has many successes with health care and business law clients, whose practices are transforming the business and health care landscape as we know it.

Michael also sponsors Being Central, a Portal for Potential, which gives access to other, pre-paid legal services.

FDA Medical Device Law and State Legal Issues Affecting MDs and Other Health Care Practitioners

(Michael H. Cohen Attorney ) — Sun, 14 Feb 2010 15:13:40 -0500

Doctors, psychologists and other practitioners who use medical devices to assess patient's "energy fields" need legal advice about FDA rules, medical board discipline, malpractice liability and related legal risks.

Let's start with the definition of a medical device given by the federal Food, Drug & Cosmetic Act, because the first issue in any energetic diagnosis with an instrument, is whether the activity is potentially regulated in some way by the FDA.

A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

In assessing the FDA status of a medical device, we turn to several searchable databases:

· Premarket Notifications (510(k)s). Medical device manufacturers are required to submit a premarket notification or “510(k)” if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code.[1]

· Registration & Listing. This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution) and listings of medical devices in commercial distribution by both domestic and foreign manufacturers.

· Product Classification. This database contains medical device names and associated information developed by the Center for Radiological Health (CDRH) within the FDA. It includes a three letter device product code and a Device Class that refers to the level of CDRH regulation of a given device.

We also search the Code of Federal Regulations (“CFR”).[2] The reason is that the devices listed in the CFR are already considered exempt from 510(k) premarket notification to the FDA, and serve as predicate devices for those new devices, for which manufacturers are seeking 510(k) clearance.

As the FDA explains in its discussion of 510(k) clearances:

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories [i.e., Class I, II or III].

In order to receive 510(k) clearance, the medical device must be “substantially equivalent” to an already approved device[3]--i.e., to a “predicate device.” Once a company receives 510(k) clearance, it need not submit the lengthier and more onerous premarket approval application (PMA).

Ideally, when a physician is using a medical device in practice, the device should have 510(k) clearance. However, we know that many such devices are being sold to the public in violation of the FDCA. Although, as noted, the FDA tends to initiate enforcement action concerning medical devices against manufacturers and distributors and not health care practitioners, since professional health care practices come under state law, the FDA still may exert jurisdiction, and/or report the matter to a state medical board. Therefore, if the device in question is not approved, we should at least search the FDA databases to determine whether the device itself has predicate devices that wouldlikely be considered “substantially equivalent,” should the manufacturer decide to file a 510(k) application for the device in question.

Note that every 510(k) submission includes a Statement of Indications for Use. The Statement:

should include specific indications, clinical settings, define the target population, anatomical sites, etc. This statement must be consistent with your labeling, advertising and instructions for use. Once the review is complete, FDA will include the Indications for Use Statement with the Substantial Equivalence (SE) letter to the applicant and make it available to the public on the Internet.

Effectively, this means that the 510(k) clearance only goes to approval of specified indications for use.[4]

The final search would be of FDA warnings letters for FDA correspondence with companies deemed to have crossed the line into violating FDCA medical device rules.

Normally, the FDA does not take enforcement action against physicians, since medical practice comes under state law and the FDA is responsible for enforcing the federal Food, Drug & Cosmetic Act (“FDCA”) and has no jurisdiction over the practice of medicine However, use of an unapproved medical device could conceivably lead to malpractice liability and/or medical board discipline.

Use of unapproved medical devices also should be disclosed in a robust informed consent form that an attorney versed in law governing complementary and alternative medicine should prepare.

[1] For riskier devices, one can search Premarket Approvals (PMA). Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices (i.e., those devices considered the riskiest). An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device.

[2] According to the FDA: “The CFR is a codification of the general and permanent rules that were published in the FR by the Executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation.” On the other hand, the Federal Register (FR) “is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents. Proposed rules are initially published in the Federal Register for public comment and subsequently published in the Code of Federal Regulations after the rule is final. Final regulations published in the FR are subsequently placed or codified into the printed edition of the Code of Federal Regulations (CFR) on an annual basis. You can find recently published FR's on the Regulations.gov web page.”

[3] A device is substantially equivalent if, in comparison to a predicate it:

· has the same intended use as the predicate; and

· has the same technological characteristics as the predicate; or

· has the same intended use as the predicate; and

· has different technological characteristics and the information submitted to FDA;

o does not raise new questions of safety and effectiveness; and

o demonstrates that the device is at least as safe and effective as the legally marketed device.

A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable..

[4] As stated in one FDA warning letter:

Failing to submit a 510(k) as required by the FDA regulations discussed above renders a device misbranded under section 502(o) of the Act, for failure to notify the agency of intent to introduce the device into commercial distribution, as required by section 510(k) of the Act. A review of our records also revealed that your firm has not listed its product as required by section 510(j) of the Act. The failure to comply with this requirement also causes your device to be misbranded under section 502(o). Until you submit a section 510(k) premarket notification and FDA reviews it and notifies you that you may legally market your device, your product is also adulterated under section 501(f)(1)(B) of the Act because the law requires, and you do not have, an approved premarket approval application that shows your device is safe and effective. For a product requiring premarket approval before marketing, the notification required by section 510(k) is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency. (21 CFR 807.81 (b)).

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Our law firm has many successes with health care and business law clients, whose practices are transforming the business and health care landscape as we know it.

Michael also sponsors Being Central, a Portal for Potential, which gives access to other, pre-paid legal services.

Vicarious Liability & Negligent Credentialing in the Integrative Care Center

(Michael H. Cohen Attorney ) — Sun, 14 Feb 2010 15:07:42 -0500

Integrative medicine clinics, wellness centers, and other holistic health care facilities (and medical spas) can incur both direct and vicarious liability.

Whereas direct liability refers to malpractice liability for one's own negligence, vicarious liability refers to liability for the negligent acts of others. Vicarious liability is frequently overlooked by owners of various medical and other health care facilities.

Within the integrative care center or medical spa, the Center itself (and its owners as well as medical director) can be vicariously liable for the negligent acts of other practitioners who work within the Center (even if these practitioners are independent contractors and not employees). Vicarious liability simply refers to the liability of A for B’s conduct, irrespective of A’s conduct. Liability flows up the chain from B to A.

The only possible protection is to ensure that the malpractice liability insurance policy explicitly covers this potential source of liability. In addition, a strong credentialing and quality assurance program can help minimize the risk of liability exposure from practitioners.

Negligent credentialing refers to malpractice liability for failing to exercise due care in hiring practitioners. This creates a bit of a dilemma. If the Center simply is a pass-through for patient visits to practitioners, then the Center need not establish a scheme to credential the Practitioners. However, the downside is that the Center loses the ability to have quality assurance controls over those the Center lets into its network, and accordingly has liability exposure.

On the other hand, once the Center undertakes a credentialing scheme, it opens itself up to potential liability for negligent credentialing and/or negligent referrals. Further, credentialing is a significant undertaking, because it requires developing at least some objective standards by which a candidate is allowed or not, standards and procedures upon which a practitioner may be removed, some minimal due process procedures for which an aggrieved practitioner can take issue with a decision, and some potential for claims from practitioners who have been denied or are removed.

Note that the Center could explicitly disclaim any credentialing effort. The marketing materials could state that each practitioner practices independently of the other and has no responsibility for the other’s care or quality of care. This could also include a statement that the Center makes no claims regarding products or services; has not evaluated the skills and abilities of the practitioners; and makes no recommendation or endorsement of them. In such case, it is vital that marketing materials not overreach and imply that practitioners are screened and certified, as consumer perception controls. This is not to say that under a directory structure the Center cannot require and verify, for example, that a Practitioner holds the license claimed. An example of this is the Yellow Pages, in which certain categories are preceded by stating “Listed parties in this section may require a license.”

Our attorneys regularly consult and advice on telemedicine and other health care law and business legal matters involving online enterprises. For legal advice concerning telemedicine and other health care practices, whether involving physicians, nurses, psychologists, or CAM providers such as acupuncturists, or even life coaches, fitness consultants, nutritional advisors, and others, contact our health care lawyers today.

Our law firm has many successes with health care and business law clients, whose practices are transforming the business and health care landscape as we know it.

Michael also sponsors Being Central, a Portal for Potential, which gives access to other, pre-paid legal services.

Patient Rights under Georgia Law

(Michael H. Cohen Attorney ) — Sun, 14 Feb 2010 14:15:07 -0500

Most states require that a statement of patient rights be posted in health care facilities.

Georgia requires a declaration as follows:

The declaration must:

contain the following language with no alterations, deletions or additions: The patient has the right to file a grievance with the Composite State Board of Medical Examiners, concerning the physician, staff, office and treatment received. The patient should either call the board with such a complaint or send a written complaint to the board. The patient should be able to provide the physician or practice name, the address and the specific nature of the complaint. Complaints may be reported to the Board at the following address or telephone number:

Composite State Board of Medical Examiners

Attn. Complaints Unit

No. 2 Peachtree Street, N.W. 36th Floor

Atlanta, GA 30303

(404) 656-3913

Further, the declaration must:

be prominently displayed in a sign that is 8 1/2 inches × 11 inches in type that is no smaller than 24 point Times Roman print in black on white background. It shall be displayed in the physician’s waiting room in an area that is not obstructed and can be easily viewed by patients.

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Our law firm has many successes with health care and business law clients, whose practices are transforming the business and health care landscape as we know it.

Michael also sponsors Being Central, a Portal for Potential, which gives access to other, pre-paid legal services.

The Bulldog at Yale Gets No Tail

(Michael H. Cohen Attorney ) — Mon, 01 Feb 2010 12:25:57 -0500

The Bulldog at Yale Gets No Tail (we used to sing that at Columbia), But he can get integrative medicine CME.

Yale is offering integrative medicine CME:

Yale School of Medicine, Integrative Medicine at Yale

Integrative medicine combines treatments from conventional medicine and complementary and alternative medicine (CAM) for which there is evidence of safety and effectiveness. Integrative Medicine at Yale was established in 2007 to create a forum for interdisciplinary research and education in complementary, alternative and integrative medicine. This symposium will showcase recent findings in CAM research and will provide attendees with evidence-based information about integrative therapies.

The mission of this conference is to: (1) showcase the breadth and depth of complementary, alternative, and integrative medicine (CAM/IM) research and clinical care already in progress by Yale researchers and clinicians; (2) educate and increase awareness among the community about integrative medicine topics and modalities, and (3) support interdisciplinary discussion and future collaboration.

In April 2008, Integrative Medicine at Yale and Yale CME sponsored the 1st Annual Yale Integrative Medicine Scientific Symposium. This conference featured presentations from experts in CAM/IM from Yale and other leading medical institutions and drew national and international attention. The symposium was attended by 170 participants. Since few opportunities exist for Yale-affiliated clinicians, researchers, and students to learn about CAM/IM therapies, demand is high for a second conference with a larger capacity.

Learning Objectives

Participants who attend will be able to:

-Describe the latest trends in the use of complementary and integrative therapies in the United States

-Identify methodological challenges in complementary and integrative medical research

-Distinguish the role of evidence in translating complementary and integrative medical research into clinical practice

-Describe recent advances in core complementary and integrative medical research areas

-Assist patients in making informed, evidence-based choices about commonly used complementary and integrative therapies

-Identify complementary and integrative therapies used by cancer patients and explore their evidence base

Thursday, March 4, 2010

5 AMA PRA Category 1 CreditsTM
Harkness Auditorium - Yale School of Medicine

333 Cedar Street

New Haven, CT

Registration Fees

Registration fee includes all conference materials and refreshment breaks

$150                             Physicians

$100                             Nurses/PAs

$100                             Allied Health Professionals

$100                             Others

$ 25                              Non-Yale Residents/Fellows/Students

Complimentary              Yale Residents/Fellows/Students

*A letter of verification from department head must accompany registration. If registering online, letter should be sent separately to Yale CME address below.

All cancellations must be received in writing (or via email) at least one week prior to the start of the conference to receive a refund. Any requests for refunds received after this date, or by telephone, will not be honored.

Center for Continuing Medical Education
333 Cedar Street
PO Box 208052
New Haven, CT
06520-8052

Accreditation Statement

The Yale School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The American Medical Association has determined that physicians not licensed in the US who participate in this CME activity are eligible for AMA PRA Category 1 Credit.

Designation Statement

The Yale School of Medicine designates this educational activity for a maximum of 5 AMA PRA Category 1 CreditsTM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Disclosure Policy

It is the policy of Yale School of Medicine, Continuing Medical Education, to ensure balance, independence, objectivity and scientific rigor in all its educational programs. All faculty participating as speakers in these programs are required to disclose any relevant financial relationship(s) they (or spouse or partner) have with a commercial interest that benefits the individual in any financial amount that has occurred within the past 12 months; and the opportunity to affect the content of CME about the products or services of the commercial interests. The Center for Continuing Medical Education will ensure that any conflicts of interest are resolved before the educational activity occurs.

Nursing Credits

Yale-New Haven Hospital is an approved provider of continuing nursing education by the Connecticut Nurses' Association, an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation. This activity is designated for a maximum of 4.5 CEU Credits.

Medical students want CAM:

Are up-and-coming young doctors going to practice the same kind of mainstream medicine as their predecessors? Will the next generation of docs turn up their noses at alternative therapies such as acupuncture, yoga, herbs and vitamins -- just like the majority of the current crop of docs? In what may come as a surprise to many mainstream physicians, the answer to those questions may be a resounding "no".

According to research published in the online edition of the peer-reviewed journal Evidence-based Complementary and Alternative Medicine (eCAM), 75 percent of medical students surveyed think it would be beneficial for conventional Western medicine to integrate with complementary and alternative medicine (CAM). CAM places emphasis on natural therapies and using the body's own healing powers instead of relying on drugs, vaccines and other standard Western treatments.

A University of California at Los Angeles (UCLA) and University of California, San Diego, research team comprised of experts in the fields of CAM, integrative medicine, Western medicine, medical education and survey development created a first of its kind 30 question survey that was distributed to 126 U.S. medical schools. Some 1,770 medical students completed the survey -- roughly, about three percent of the 68,000 medical students nationwide. Although the response rate to the survey was fairly low, the researchers say it provided valuable insights into current medical students' perceptions of CAM.

For example, the findings revealed that 77 percent of the medical student participants agreed patients whose doctors are knowledgeable about complementary and alternative medicine in addition to conventional medicine benefit more than those whose doctors are only familiar with Western medicine. In fact, 74 percent agreed that a medical system which integrated conventional medicine with CAM could be more effective that either type of medicine used independently.

A whopping 84 percent of the participants surveyed said CAM contains beliefs, ideas and therapies that could benefit conventional medicine. Some of this attitudinal shift in medical students could be the result of personal experiences -- almost half of the participants said they had used complementary and alternative treatments themselves.

The Washington Post keeps us out of a nutritional haze:

Many people take just one supplement, a multivitamin. Here are some tips for choosing the best multivitamin, from Andrew Weil, founder of the Arizona Center for Integrative Medicine at the University of Arizona, which focuses on combining alternative treatments with conventional medical practices...

Others see dietary supplements as a type of insurance: "There is a big discrepancy between what people think they eat and what they actually are eating," said Kelly Dorfman, a nutritionist in North Potomac. "Taking nutrients just makes good sense."

And for certain medical conditions, such as diabetes, supplements are highly recommended. Benjamin Caballero, a professor at the John Hopkins Bloomberg School of Public Health, said he does not think any "healthy person with a healthy diet" should take dietary supplements, with a few exceptions: "pregnant woman; children under the age of 6 months who are being breast-fed, as breast milk is not rich in vitamins A, C, and D; and people with gastrointestinal problems." And, in those cases, he believes a doctor would have already been consulted.

A quick blood test at the doctor's office can determine a person's vitamin levels. District nutritionist Mindy Block Feirman recommends asking for the test during your next physical. "Many individuals are coming back with their blood work low on Vitamin D," Feirman said. "We don't want to sit in the sun because we don't want to get skin cancer, so we don't get enough Vitamin D." She takes Vitamin D and calcium supplements every day.

Consumers should research brands before they buy. Siobhan DeLancey, a spokeswoman for the Food and Drug Administration, said that the FDA can take action against a manufacturer only after a supplement is on the market and complaints have been filed. Because of this lack of oversight, many labels are misleading.

"Vague claims, which make no mention of a disease but offer generalizations such as 'improves heart health' or 'builds strong bones,' have no FDA stamp of approval," Dorfman said.

Sleep well with Chinese medicine:

An approach that can also aid in the quest for a good night's sleep is that of Chinese Medicine. This ancient healing system has offered relief to the sleep challenged for thousands of years. While new to many, Chinese Medicine is mainstream in China, and it is used today for a wide range of conditions by an estimated one-fourth of the world's population.

The Roots of Traditional Chinese Medicine

Chinese Medicine is considered the oldest, most continuously practiced, professional, literate medicine in the world. Written records date back over 2000 years, although the medicine is believed to go back even further. Some experts believe Chinese Medicine is at least 5000 years old.

Chinese Medicine employs acupuncture, herbal medicine, nutritional therapy, tuina (pronounced "twee nah") massage, acupressure, and qigong.

The Huangdi Neijing (The Yellow Emperor's Inner Canon) is considered the Bible of Chinese Medicine, emphasizing medical theory and acupuncture. Some scholars estimate that it dates back to the first century B.C. In addition, The Shen Nong Ben Cao Jing (The Divine Farmer's Materia Medica Classic) details the medicinal uses of 365 herbs and is believed to have been compiled around 200 A.D. Many of the protocols mentioned in these ancient texts are still used today....

Chinese Medicine and the West

The development of East-West relations has promoted the use and interest of Chinese Medicine in the United States. During the past 30 years, the practice of Chinese Medicine has dramatically increased here. The National Institutes of Health (N.I.H.) has reported that visits to Chinese Medicine practitioners in the U.S. tripled from 1997 to 2007.

At the same time, the United States is seeing an increase in the practice of integrative medicine. University centers and hospitals are offering Chinese Medicine. Integration has been common in China, where Chinese Medicine is often practiced side-by-side with Western Medicine.

The Chinese Medicine Approach to Sleep

Insomnia comes in various forms, such as trouble falling sleep, difficulty staying asleep, and having dream-disturbed sleep. When a Chinese Medicine practitioner is gathering information to put together a treatment plan, the pattern of the sleep disturbance as well as health and lifestyle issues will be taken into consideration.

A Chinese Medicine practitioner might use the term "calm the shen" when describing a treatment principle. "Shen" is best translated as the spirit of the person in a nonreligious sense. When evaluating Shen, the Chinese Medicine practitioner is looking for the emotional state and presence (or lack) of radiance, calm, and balance. Often with sleep disturbances, the patient will be experiencing patterns of stress, anxiety, or agitation. Chinese Medicine would call this "disturbed shen."

A new book compares and contrasts shamanism and psychiatry:

Review - Psychiatrists and Traditional Healers
Unwitting Partners in Global Mental Health
by Mario Incayawar, Ronald Wintrob, Lise Bouchard (Editors)

This may well be because positive aspects of health (to undertake effectively clinical care, prevention and health promotion) have recently incorporated the emerging concepts of complementary and integrative medicine as attempts to harmonize conventional or scientific medicine and traditional medicine. (Juan E. Mezzich, President of the World Psychiatric Association, 2005-2008, p. xv) But what has led to this idea of complement and integrating traditional healing in western medicine? According to a general observation, expressed concisely by Raymond H. Prince, Emeritus Professor of Psychiatry, that their treatments, whatever they were, were as efficacious as his own. (Foreword, p. xi)

To start with, it is relevant to realize upfront that "the majority of the 450 million patients with mental disorders around the world are not receiving even the most basic mental health care. In developing countries, 76.3%-85.4% of serious cases receive no treatment". (ch 20, p. 251) And the number of people with psychiatric disorders is likely to rise in the coming decade becoming a pressing global issue.

1. DIAGNOSIS

Diagnosis similarity is a one of the topics addressed in the book. It is assumed that diagnosis and treatment are 'evidence-based' and that evidence is 'scientific'. So why are there so many people that turn to traditional alternative medicine? (ch 1) Don't people want science? There is a need to prove traditional healer's skills relying on their ability to provide a similar diagnosis (ch 5) and that is important in the sense that for centuries, Quichua people/ Inca Confederation (Bolivia, Ecuador, Peru and parts of Argentina, Chile and Columbia) lived under a regime of domination and exploitation which still persists today. Oppression, persecution and imprisonment. (ch 5, p. 54, 55; the same also happened in South Africa, ch 16) The diagnosis situation is a polemic one, even among psychiatrists, since there are several classification systems around the world ("DSM-IV", produced by the American Psychiatric Association; "International Classification of Diseases" (ICD) an international standard diagnostic classification for a wide variety of health conditions, including mental and behavioral disorders; Chinese Society of Psychiatry's Chinese Classification of Mental Disorders (currently CCMD-3), Latin American Guide for Psychiatric Diagnosis (GLDP). The Maori (New Zealand) have openly questioned the use of a diagnostic manual such as DSM IV because it seems to conflict with cultural understanding. (ch 19, p. 247) Treatment is in some cases not as effective as in Western Medicine (ch 14) but the fact that symptoms and diagnosis are correctly assessed, or it is assed as accurately as in Western Medicine, is important in the sense that it attests 1) seriousness in the observation of the patient by traditional healers; 2) affirming traditional healing knowledge itself as a different alternative/ possible method of classification.

2. INTEGRATION VS COLLABORATION

The WHO Strategy for Traditional Medicine 2002-2005 (World Health Organization, 2002) has encouraged countries to integrate traditional medicine within national health care systems, safely, and at affordable prices for the general population. But a main question remains: what aspects to keep from biomedicine and which one to eliminate? By whose standards? How can one consider legitimacy on this topic and why to address it, it is better to say collaboration instead of integration? (ch 2, p. 17, 18, 22)

Collaboration can be, for example, an experience of culture immersion where anthropology and cultural psychiatry meet (ch 6, p. 76), promoting a closer relation with the environment (ch 19), or engaging in the doctor as someone multi-dimensional, inserted in a community and not so much office based (ch 3, ch 8). The main idea is that a medical pluralism model that represents a health care environment should be a goal (ch 8, p. 105). Disregarding culture and cultural heritage when it comes to health may have serious consequences in disrupting individuals and social order. (ch 9)

The interaction between health, psychiatry and religion is also explored in the book. In Italy, religion plays a very important role in healing (ch 18); Islam, promotes self-help through religion but also encourages family, community, doctors and psychiatrists as additional resources (ch 15); Japan's view psychiatry is a complex one, precisely because it triggers a cultural ambiguity: should one aim at healing or salvation, should illness be battled or accepted? (ch 13)

Read the review (excerpted above).

Integrative medicine award awarded (now I know that's redundant!):

GAINESVILLE, VA -- In recognition of her commitment to integrative therapy, the economic power of Integrative Medicine, the American Association of Integrative Medicine, recently awarded Taras NK Raggio, MPA, HHP the prestigious Board Certified in Integrative Medicine, BCIM™, credential by the American Association of Integrative Medicine (AAIM)™. The BCIM designation is reserved for those individuals who are able to meet the stringent requirements of AAIM in the areas of knowledge, skill, education, training, and experience in their health care specialty.

About Taras NK Raggio, MPA, HHP, BCIM
For the past 10 years Taras has address whole person management; mind, body, spirit, to include negative emotions associated with stress. Her service differential is to educate, inspire, and integrate life coaching and wellness programs as an alternative to traditional diagnosis and treatment. Her specialties include: Stress Depression/Anxiety Emotional Wellbeing Aromatherapy and Breath work. Taras' honors include: Masters of Public Administration (Public Health); Credentialed Holistic Health Practitioner, Certified Holistic Stress Management Specialist, Life Coach, Lifestyle and Weight Management Specialist, and Clinical Aroma therapist.

Her Company, TARAS TECHNIQUES, LLC- Holistic Health Services provides Health Promotion Programs for employers, large and small. Established in 2001, the firm is a National Minority Certified Woman; Veteran owned and operated small business comprised of subject matter experts with extensive military and commercial experience. The goals of the firm are to deliver behavioral health and lifestyle management solutions to corporations and public safety organizations that enhance the overall health and wellness of a workforce.

About AAIM
AAIM is an international membership association that brings together health care professionals from a variety of specialties. Membership is comprised of integrative, alternative, holistic, complementary, and traditional health care professionals. This forum allows members to share information in an effort to increase both public and professional knowledge and acceptance of integrative medicine, thereby benefiting the patient as well as the practitioner.

F or membership information, please visit the AAIM website at www.aaimedicine.com or contact AAIM Headquarters toll-free at (877) 718-3053. American Association of Integrative Medicine 2750 E. Sunshine • Springfield, MO 65804

Media Contacts
Phone: 703.636.4123
Email: info@tarastechniques.com

Website Link: http://www.tarastechniques.com/tarasraggio

For additional information, please contact:
Contact: Taras NK Raggio, MPA, HHP, BCIM
Telephone: (703) 636-4123
Fax: (703) 636-4123
E-mail: info@tarastechniques.com

- Dr. Mark Beitel, a licensed clinical psychologist and psychotherapist, has joined the Greenwich Hospital's Center for Integrative Medicine at 35 River Road in the town's Cos Cob section, as a clinical psychologist.

The Minnesota complex of hospitals providing integrative medicine services gets profiled:

AN OVERVIEW
An overview of how complementary medicine expanded in this region of the country begins with the Hennepin County Medical Center. It began clinical trials with acupuncture in 1986 and in 1993, and it was the first conventional medical facility in the United States to open an alternative medical clinic.

Two years later, the University of Minnesota created the Center for Spirituality and Healing. This center was designed to conduct research, educate health professionals and empower consumers. Once a public clinic, the Center for Spirituality and Healing closed that operation in 2002.

Then in 1998, the second oldest hospital in Minnesota, Lakeview Hospital, began offering a holistic approach to care by incorporating non-traditional therapies with standard conventional patient care. Administrators there believed the addition of complementary therapies benefited patients by providing pain relief, stress reduction and recovery enhancement.

In 1999, Children’s Hospitals and Clinics of Minnesota launched an integrative medicine program in its oncology department following suggestions by parents who felt their children needed more help managing symptoms. The program used therapies in the treatment of cancer with simple approaches like mind/body skills, aromatherapy, and massage. To date, the integrative medicine program at Children’s, one of sixteen in the nation, is the largest and longest running.

In 2000, the Woodwinds Health Campus opened in Woodbury. It is an 86-bed hospital built around a holistic care model that recognizes the role of the individual and the family in the health care experience.

In 2002, the concept for the Penny George Institute for Health and Healing was developed around the idea of creating an optimal healing environment. By 2003, the inpatient program was in operation, managed by teams of nurses. A year later, its outpatient clinic was opened, featuring an acupuncturist, massage therapist, nurse/healing coach, and nutritionist, and the healing institute has continued to expand its services to date. In addition to inpatient and outpatient care, in 2007 the Penny George Institute opened a center to research both clinical trials, as well as the economics of integrative medicine.

In 2006, Regions Hospital opened its Complementary Care Therapies Department as a result of an internal grant opportunity. Regions had been trying to expand its nursing services, and there was interest from nursing and other professionals, but a lack of time. With the grant in place, two nurse managers were able to create the complementary therapies program.

PHILOSOPHY, THERAPIES AND GOALS
The following is a brief look at the health care clinics, centers and health systems that will be explored in more depth in coming months.

Integrative medicine at the new Disney center:

The new Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center is not only equipped with the latest technology but it has a complete floor reserved for Eastern-style therapies such as herbal medications, yoga and meditation.

With the goal of treating body, mind and spirit, the Sheri and Roy P. Disney Center for Integrative Medicine will offer complementary therapies that have proven safe and effective when used with conventional approaches including radiation and chemotherapy. These therapies include acupuncture, tai chi, Qigong and guided imagery.

“Integrative medicine considers all aspects of a person’s lifestyle and combines complementary and conventional medical therapies into an individualized, evidence-based treatment program,” said oncologist Lisa Schwartz, M.D., Director of the Center for Integrative Medicine.

“By giving patients access to a broad range of proven therapies, we ultimately give them more control over their own destinies. We also hope to contribute to the increasing body of research that demonstrates patients using integrated therapies experience improved quality of life and better outcomes compared to patients receiving conventional therapies alone.”

Sheri and Roy P. Disney contributed $1 million to the integrative medicine program. Roy P. Disney’s parents, the late Roy E. Disney and Patricia Disney, donated $10 million on behalf of their family to the new Providence Saint Joseph Medical Center free-standing cancer center.

“We do not live in isolation but as an integrative whole,” Roy P. Disney said. “Sheri and I feel strongly that this cancer center is an extension of that philosophy.”

AAIM has a new credential:

AAIM Releases First Integrative Medicine Certifications

New AAIM Board Certifications lend additional credibility to complementary and alternative medicine (CAM) practitioners worldwide.

01.20.2010 – Springfield, MO – The American Association of Integrative Medicine (http://www.aaimedicine.com), the medical society for the 21st century, today announced the release of certifications designed to enable holistic, natural and complementary and alternative health professionals to lend additional credibility to their practice of integrative healthcare. Board certification also enables consumers to make an informed decision when selecting a provider.

“Today there are millions of medical practitioners that are embracing both traditional and alternative medicine in response to increasing consumer demand,” said Dr. Zhaoming Chen, Chief Spokesman & Board Chairman for the American Association of Integrative Medicine (AAIM). “However, it has become more difficult for individuals to choose, and for practitioners to stand out from other providers. These certifications ensure quality in the industry by providing a high standard.”

For licensed integrative medicine professionals, including physicians, nurses, therapists, veterinarians and dentists, AAIM Board Certification in Integrative Medicine (BCIM) is available to those with a Bachelor’s Degree or higher from an accredited college or university, a current license from at least one state and a minimum of three years of experience in a role related to integrative medicine. In addition, professionals must pass the rigorous AAIM Board Certification exam.

For health practitioners, such as naturopaths, homeopaths, nutritionists, massage therapists, reflexologists, Reiki practitioners, herbalists and practitioners of other CAM modalities, AAIM Board Certification in Integrative Health (BCIH) is available to those with a Bachelor’s Degree or higher from an accredited college or university and a minimum of three years of experience in a role related to integrative medicine. Like the BCIM certification, individuals must also pass the rigorous AAIM Board Certification exam.

For more information about becoming certified visit www.aaimedicine.com or call toll free (877) 718-3053.

# # #

About the American Association for Integrative Medicine
Founded in 2000 and headquartered in Springfield, Missouri, the American Association for Integrative Medicine (AAIM) educates and certifies practitioners in the integration of Eastern and Western medicine with the goal of improving clinical outcomes for patients. For consumers, they provide information and education about the benefits of integrative health care, as well as a careful selection of trusted providers. For healthcare providers, AAIM promotes their high standards of professional competence to consumers and provides a gathering place for like-minded individuals who are committed to preserving global indigenous therapies and evaluating new approaches. They have thousands of members worldwide representing over 22 medical specialties. For more information, visit www.aaimedicine.com.

Press Contact: Carol Arnold, Arnold Communications, (877) 718-4604 x2, carol@arnoldcomm.com.

Duke offers mindfulness training:

In-depth professional training and development are cornerstones of the program at Duke Integrative Medicine. Participants from across the medical and allied health fields—medicine, nursing, physical therapy, health education, teaching, exercise physiology, psychotherapy, nutrition, acupuncture, massage therapy, acupuncture, etc—are encouraged to register for our programs.

Mindfulness Training for Professionals

An 8-day training in two parts:

February 4-7, 2010 and March 18-21, 2010.

Mindfulness Training For Professionals offers an extensive training in this core concept, designed to help optimize the health and well-being of clients and patients. Mindfulness is recognized as an increasingly important element in healing, and in the helping relationship between professionals and their clients and patients.

Our attorneys regularly consult and advise on telemedicine and other health care law and business legal matters involving online enterprises. For legal advice concerning telemedicine and other health care practices, whether involving physicians, nurses, psychologists, or CAM providers such as acupuncturists, or even life coaches, fitness consultants, nutritional advisors, and others, contact our health care lawyers today.

Our law firm has many successes with health care and business law clients, whose practices are transforming the business and health care landscape as we know it.

Michael also sponsors Being Central, a Portal for Potential, which gives access to other, pre-paid legal services.

Birthday blessings from Spirit

(Michael H. Cohen Attorney ) — Fri, 29 Jan 2010 02:39:50 -0500

I am always amazed at how we live in multiple worlds, the human and the cosmic/divine, the material and spiritual, the world of the mundane and then the numinous sacred.

In the world of psychological reality I was processing some thoughts today about tomorrow's birthday.

Then I was also sitting in a networking meeting - second of the day - listening to information upon information about networks of networks. My eyes drifted, and suddenly I was in meditation.

The God Force erupted - I'll just call it that, maybe it's quantum reality or the nanosphere or shifting templates or inter-dimensional spaces or just a wall of White, which is what the energy looked like as it spread through my being and all the space in the room, and then all the space in between space, and then into all of space and the non-space space.

Anything that had previously been occupying a space of blockage instantly blew out and cleared, and I was left in a peace that surpassed even the room or the planet on which the room in an investment banking firm sits.

Yes, I had a moment or something that is not even recognizable as a moment, of cosmic consciousness.

It was like the Haftorah portion I read on my Bar Mitzvah: in the year that King Uzaiah died (ok, that Obama was elected), I saw the Lord sitting on a throne (ok, it was a wall of white energy permeating the entire cosmos, and I didn't really "see" it, my third eye opened and became the whole universe) and around were seraphim (well I did see white shadows, outlines of energy beings, behind the speaker) and His entire Glory filled the hall (that's a fairly good description).

Funny, because the name Isaiah kept coming to me all day.

It was an e-card (energy card) from On High. What a great experience, what a wonderful. Just then I landed back in my body and felt a happy radiance. It was not merely a happy birthday present, it was an ecstatic one.

I realized some hours later my purpose is to channel this energy. So put another way it's simply to be. That is the literal translation of the divine name in Hebrew--literally, BEING. Some folks write it as "I am that I am." I understand the Hebrew root as a verb. Being itself. Am-ness. Presence. To be one with the Presence and let it, Being, flood the being of the tiny self.

And whatever comes from that space comes from a much larger space than the small limited self.

The still small voice becomes a mighty roar.

Religious language points beyond itself to a numinous reality that cannot be confined by words nor limited by any human conception, for how can the infinite be described via the finite? But then that is the journey, as one Baba put it, from the finite to the infinite.

And rather than coming when sought on the official birthday it took me by surprise the day before and during a networking meeting (second of the day) when I was not looking.

Maybe that's how Isaiah got it too. One ordinary day in an extraordinary moment, a portal opened, and revelation unfolded.

Then, thrust back into ordinal time, his job to put words to experience, and to let his being become a continuous aperture for translation of divine energies into the human realm.

And to have the humility to recognize his human side, too, and the limitations of pouring the infinite into finite, of bringing the formless into form.

Must you be a physician to perform laser techniques?

(Michael H. Cohen Attorney ) — Mon, 25 Jan 2010 12:20:25 -0500

Medical spa owners frequently call for legal advice on the question of whether they need a physician to perform cosmetic laser techniques?

The answer is that every state has different laws regulating the practice of medicine. State laws also regulate estheticians, cosmetologists, and other beauty industry professionals.

It's sometimes difficult to know which board regulates laser cosmetic techniques, although the term "laser surgery" gives a good clue.

Our attorneys specialize in guiding medical spas, cosmetics facilities, beauty establishments, and wellness and fitness industry professionals and corporations regarding the legal rules regulating aesthetic medicine and cosmetics procedures such as laser, intense pulsed light (IPL), Botox, Restalyne, and other therapies.

Below is some regulation in Georgia, as an example of how the regulations can pinpoint the legal requirements for companies venturing into this complex legal arena:

§ 43-34-244. (For effective date, see note.) Two levels of license; application
(a) There shall be two levels of a license for a cosmetic laser practitioner: assistant
laser practitioner and senior laser practitioner.
(b) Any person desiring to obtain a license as a cosmetic laser practitioner under the
terms of this article shall make application to the board as follows:
(1) An applicant for an "assistant laser practitioner" license shall present proof that
he or she:
(A) Holds a current valid license or certificate of registration as a physician
assistant, licensed practical nurse, nurse, esthetician, or master cosmetologist, or
has previously held a license or certificate of registration as a medical practitioner;
and
(B) Has received at least three laser certificates from attending laser/intense
pulsed light (IPL) courses as approved by the board, directly taught by a licensed
physician or certified continuing medical education or continuing education educator.
If, after review of the application, it is determined that the applicant is at least 21
years of age; has met the minimum educational requirements; is of good moral
character; and is possessed of the requisite skill to perform properly cosmetic laser
services, a license shall be issued to the applicant entitling the applicant to practice
the occupation of cosmetic laser practitioner at the assistant laser practitioner level
under the on-site supervision of a senior laser practitioner.
(2) An applicant for a "senior laser practitioner" license shall present proof that he
or she:
(A) Holds a current valid license or certificate of registration as a physician
assistant or nurse or has previously held a license or certificate of registration as a
medical practitioner;
(B) Has at least three years of clinical or technological medical experience, or
both;
(C) Has been or was licensed or nationally board certified as a medical
practitioner for at least three years; and
(D) Has received at least two laser certificates from attending laser/intense
pulsed light (IPL) continuing medical education courses as approved by the board,
directly taught by a licensed physician or certified continuing medical education or
continuing education educator. If, after review of the application, it is determined
91
that the applicant is at least 21 years of age; has met the minimum educational and
clinical training requirements to perform cosmetic laser services with indirect
supervision; is of good moral character; and is possessed of the requisite skill to
perform properly these services, a license shall be issued to the applicant entitling
the applicant to practice the occupation of cosmetic laser practitioner at the senior
laser practitioner level pursuant to the protocols of a consulting physician.
(c) Any person desiring to obtain a license as an "assistant laser practitioner" who
does not meet the requirements of paragraph (1) of subsection (b) of this Code
section shall also be eligible for a license as an "assistant laser practitioner" if he or
she makes application to the board within nine months of the effective date of this
article and presents proof that he or she:
(1) Prior to the effective date of this article, obtained a minimum of at least 2,000
hours of experience in administering cosmetic laser service; and
(2) Has received at least two laser certificates from attending laser/intense pulsed
light (IPL) courses, directly taught by a licensed physician or certified continuing
medical education or continuing education educator.
(d) Should an applicant have a current cosmetic laser practitioner license or
certificate of registration in force from another state, country, territory of the United
States, or the District of Columbia, where similar reciprocity is extended to this state
and licensure requirements are substantially equal to those in this state, and have
paid a fee and have submitted an application, the applicant may be issued a license
at the appropriate level entitling him or her to practice the occupation of a cosmetic
laser practitioner at that level, unless the board, in its discretion, sees fit to require a
written or a practical examination subject to the terms and provisions of this article.
HISTORY: Code 1981, § 43-34-244, enacted by Ga. L. 2007, p. 626, § 1/HB 528;
Ga. L. 2009, p. 859, § 1/HB 509; Ga. L. 2009, p. 989, § 2/SB 104.
§ 43-34-245. (For effective date, see note.) Expiration of licenses; license renewal
(a) All licenses shall expire biennially unless renewed. All applications for renewal
of a license shall be filed with the board prior to the expiration date, accompanied by
the biennial renewal fee prescribed by the board. A license which has expired for
failure of the holder to renew may only be restored after application and payment of
the prescribed restoration fee within the time period established by the board and
provided the applicant meets such requirements as the board may establish by rule.
Any license which has not been restored within such period following its expiration
may not be renewed, restored, or reissued thereafter. The holder of such a canceled
license may apply for and obtain a valid license only upon compliance with all
relevant requirements for issuance of a new license.
(b) As a condition of license renewal, the board shall require licensees to provide
proof, in a form approved by the board, of a minimum of five hours of continuing
education courses as approved by the board in the area of cosmetic laser services,
equipment safety and operation, procedures, and relative skin modalities, directly
taught by a licensed physician or certified continuing medical education or continuing
education educator.
92
HISTORY: Code 1981, § 43-34-245, enacted by Ga. L. 2007, p. 626, § 1/HB 528;
Ga. L. 2009, p. 859, § 1/HB 509.
§ 43-34-246. (For effective date, see note.) Sanctions
The board may impose on a cosmetic laser practitioner or applicant any sanction
authorized under subsection (b) of Code Section 43-34-8 upon a finding of any
conduct specified in subsection (a) of Code Section 43-34-8.
HISTORY: Code 1981, § 43-34-246, enacted by Ga. L. 2007, p. 626, § 1/HB 528;
Ga. L. 2009, p. 859, § 1/HB 509.
§ 43-34-247. (For effective date, see note.) Petition to restrain or enjoin unlicensed
cosmetic laser practitioner
The practice of providing cosmetic laser services is declared to be an activity
affecting the public interest and involving the health, safety, and welfare of the
public. Such practice when engaged in by a person who is not licensed as a cosmetic
laser practitioner or otherwise licensed to practice a profession which is permitted
under law to perform cosmetic laser services is declared to be harmful to the public
health, safety, and welfare. The board or the district attorney of the circuit where
such unlicensed practice exists, or any person or organization having an interest
therein, may bring a petition to restrain and enjoin such unlicensed practice in the
superior court of the county where such unlicensed person resides. It shall not be
necessary in order to obtain an injunction under this Code section to allege or prove
that there is no adequate remedy at law, or to allege or prove any special injury.
HISTORY: Code 1981, § 43-34-247, enacted by Ga. L. 2007, p. 626, § 1/HB 528;
Ga. L. 2009, p. 859, § 1/HB 509.
§ 43-34-248. (For effective date, see note.) Agreement with consulting physician
(a) Any facility providing cosmetic laser services other than hair removal using
lasers or pulsed light devices shall have an agreement with a consulting physician
who shall:
(1) Be trained in laser modalities;
(2) Establish proper protocols for the cosmetic laser services provided at the
facility and file such protocols with the board;
(3) Examine each patient prior to any cosmetic laser service other than hair
removal using lasers or pulsed light devices being performed; provided, however,
that a consulting physician may delegate the authority to perform such examination
to a physician's assistant who is a licensed cosmetic laser practitioner, in accordance
with a job description approved by the board, or to a registered professional nurse
who is also an advanced practice registered nurse as defined in paragraph (1.1) of
Code Section 43-26-3 and who is a licensed cosmetic laser practitioner, pursuant to
a protocol approved by the board; and provided, further, that in facilities subject to
the provisions of Code Section 43-34-249.1 such delegation may be to: (A) a
physician's assistant who is not required to be a licensed cosmetic laser practitioner,
in accordance with a job description approved by the board; or (B) a registered
professional nurse who is also an advanced practice registered nurse who is not
93
required to be a licensed cosmetic laser practitioner, in accordance with a protocol
approved by the board; and
(4) Be available for emergency consultation with the cosmetic laser practitioner or
anyone employed by the facility.
(b) Any facility providing cosmetic laser services other than hair removal using lasers
or pulsed light devices shall have a supervisor present at the facility or immediately
available for consultation and supervision either personally or via
telecommunications. The supervisor shall supervise the performance of all cosmetic
laser services performed by a person other than the consulting physician. The
supervisor shall be a physician licensed under this chapter who is trained in laser
modalities or a senior laser practitioner.
(c) (1) Any facility providing cosmetic laser services other than hair removal using
lasers or pulsed light devices shall post a sign listing the consulting physician's name,
emergency contact number, his or her board certification and specialty, and the
address of his or her principal place of practice, and indicating whether he or she is
presently on site at the facility.
(2) If the consulting physician is not on site for any period of time during which the
facility is open, the facility shall post a sign indicating who is presently acting as the
supervisor for the facility and that person's name, emergency contact number, his or
her degrees and qualifications, and the type of cosmetic laser practitioner license
held.
HISTORY: Code 1981, § 43-34-248, enacted by Ga. L. 2007, p. 626, § 1/HB 528;
Ga. L. 2009, p. 859, § 1/HB 509; Ga. L. 2009, p. 989, § 3/SB 104.
§ 43-34-249. (For effective date, see note.) Informed consent
(a) Prior to receiving cosmetic laser services from a cosmetic laser practitioner, a
person must consent in writing to such services and shall be informed in writing of
the general terms of the following:
(1) The nature and purpose of such proposed procedure;
(2) Any material risks generally recognized and associated with the cosmetic laser
service to be performed which, if disclosed to a reasonably prudent person in the
customer's position, could reasonably be expected to cause such prudent person to
decline such proposed cosmetic laser services on the basis of the material risk of
injury that could result from such proposed services;
(3) The name of, degrees and qualifications held by, and type of licenses obtained
by the individual who will be performing the cosmetic laser service, and with respect
to cosmetic laser services other than hair removal, the supervisor and the consulting
physician;
(4) The steps to be followed after the cosmetic laser service is performed in the
event of any complications; and
(5) With respect to cosmetic laser services other than hair removal, the emergency
contact information for the consulting physician and the address of his or her
94
principal place of practice.
(a.1) After receiving each cosmetic laser service other than hair removal, a person
shall be informed in writing of the information required by paragraphs (4) and (5) of
subsection (a) of this Code section.
(b) It shall be the responsibility of the cosmetic laser practitioner to ensure that the
information required by subsections (a) and (a.1) of this Code section is disclosed
and that the consent provided for in this Code section is obtained.
(c) Where the consumer is under 18 years of age, the consent of the consumer's
parent or legal guardian shall be required.
(d) The board shall be required to adopt and have the authority to promulgate rules
and regulations governing and establishing the standards necessary to implement
this Code section specifically including but not limited to the disciplining of a
cosmetic laser practitioner who fails to comply with this Code section.
(e) Nothing in this Code section shall prohibit the information provided for in this
Code section from being disclosed through the use of video tapes, audio tapes,
pamphlets, booklets, or other means of communication or through conversations
with the cosmetic laser practitioner; provided, however, that such information is also
provided in writing and attached to the consent form which the consumer signs.
HISTORY: Code 1981, § 43-34-249, enacted by Ga. L. 2007, p. 626, § 1/HB 528;
Ga. L. 2009, p. 859, § 1/HB 509; Ga. L. 2009, p. 989, § 4/SB 104.
§ 43-34-249.1. (For effective date, see note.) Waiver
The board shall have the authority to waive the requirements of subsection (c) of
Code Section 43-34-248 and paragraph (5) of subsection (a) of Code Section 43-34-
249 for facilities offering cosmetic laser services which serve as a principal place of
practice at which a physician regularly sees patients if medical services are regularly
performed at such facilities. For purposes of this Code section, "medical services"
shall mean the general and usual services and care rendered and administered by a
physician.
HISTORY: Code 1981, § 43-34-249.1, enacted by Ga. L. 2009, p. 989, § 5/SB 104.
§ 43-34-250. (For effective date, see note.) Advisory committee
The board shall appoint an advisory committee. The advisory committee shall
include licensed cosmetic laser practitioners licensed under this article and such
members as the board in its discretion may determine. The advisory committee shall
include at least one person licensed to practice medicine under this chapter and
specialized in a field with expertise in the biologic behavior of the skin. Members
shall receive no compensation for service on the committee. The committee shall
have such advisory duties and responsibilities as the board may determine, including
but not limited to consulting with the board on the issuance, denial, suspension, and
revocation of licenses and the promulgation of rules and regulations under this
article. The initial members of the advisory committee may include persons eligible
for licensing under this article. Subsequent advisory committee members must be
licensed pursuant to this article.

Our law firm has many successes with health care and business law clients, whose practices are transforming the business and health care landscape as we know it.

Michael also sponsors Being Central, a Portal for Potential, which gives access to other, pre-paid legal services.

FDA can seize unapproved medical devices used for "energy diagnosis"

(Michael H. Cohen Attorney ) — Sun, 24 Jan 2010 12:40:39 -0500

If you are performing an "energetic diagnosis" for your healing or health care practice, beware of FDA medical device rules.

According to the federal Food, Drug & Cosmetic Act (FDCA), medical devices must be approved by the FDA prior to introduction in state commerce.

Merely stating that a machine or instrument is not a medical device or that it simply scans the body energetically is not enough.

Our law office represents manufacturers, distributors, and physicians and other health care providers involved in alternative energy devices that are supposed to read the patient's bio-energy (bioenergy) or energy field (aura). These present significant legal issues, including FDA medical device law, licensing law, professional discipline provisions of state medical boards and other professional regulators, malpractice liability (negligence), informed consent, insurance reimbursement, and other health care law issues. If you need legal advice concerning an FDA medical device used in a complementary and alternative medicine (CAM) or integrative health care practice, call one of our attorneys today. Our lawyers are experienced in FDA medical device, dietary supplement, and related law.

Below is just one warning letter suggesting the length and breadth of FDA enforcement action. This was retrieved when searching the FDA warning letters for light therapy, energy diagnosis, or biofeedback.

June 18, 2003

WARNING LETTER

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ms. Nadine M. Donahue,
CEO and President
Bioscan, Inc.
45 Dusty Trail Drive
Placitas, New Mexico 87043

Ref. #: DEN-03-18

Dear Ms. Donahue:

We are writing to you because of the regulatory problems involving the BioFind III (or Biofind), BioPack II (or BioPack), Light Patch, Spinal Pad, and Knee Saver products, which are manufactured or distributed by your firm. These products are medical devices under section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act). Your firm fails to comply with applicable premarket notification requirements and the agency’s Quality System/Good Manufacturing Practice Regulation.

A. Violation of premarket notification requirements

Information on your firm’s website at http://www.bioscanlight.com indicates violation of premarket notification requirements. The law requires that manufacturers of medical devices obtain marketing clearance for their products from the FDA before they may offer them for sale. However, your firm has not submitted a premarket notification (510(k)) submission and obtained marketing clearance before it began marketing the Knee Saver by offering it for sale on your website. In addition, your firm may be marketing a new product called the Podiatric LED Device: Neuropathy Boot. This product appears on your firm's website. We have not received a premarket notification submission for this product and we request that you provide information on the marketing status-of this device. We also urge you to review all of the products that your firm distributes to assure that required premarket clearances have been obtained.

Also, our records show that, while your firm submitted premarket notification (510(k)) submissions for the BioFind III (or Biofind), BioPack II (or BioPack), Light Patch, and Spinal Pad devices, you are marketing these devices for many new indications for use for which you have not obtained marketing clearance. Examples of these new indications for use, taken from your firm’s website, through which customers can buy the products, include the following: treatment of corneal ulcers, stimulates the release of adenosine triphosphate (ATP), increases RNA and DNA synthesis, increases phagocytosis, and stimulates acetylcholine release. These are major changes or modifications in the intended use of these devices and require new premarket notification submissions (21 CFR 807.81 (a)(3)(ii)).

In general, your BioPack II (or BioPack), Light Patch, and Spinal Pad devices containing infrared diodes were cleared as infrared lamps that provide topical heating in a therapeutic range, not for photonic or light therapy; and the visible red diodes that do not provide topical heating were not to be discussed in your device labeling, etc. Specifically, the only indications for use that these devices were cleared for are: Use whenever hot applications are desirable for personal comfort and whenever recommended by a licensed medical professional, providing temporary relief of minor aches and pains in muscles and joints, aiding in relaxation of muscles, helping to provide for a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief, and providing a temporary increase in local blood
circulation.

With respect to the BioFind III (or Biofind) device, the only cleared indication for use is for galvanic skin measurement for biofeedback information. Also, your firm was informed by FDA during the 510(k) review process in 2001 that scanning the whole body and not just two points in the body is a new intended use for which the predicate device was not cleared, and your firm subsequently agreed to delete references to the scanning as well as to limit other specified claims.

The kind of information your firm needs to submit in order to obtain premarket clearance for the Knee Saver and for the new intended uses for your other products is described on the agency’s Internet website at http://www.fda.gov/cdrh/devadvice/3122.html. Please be advised that your Premarket Notification submissions should include valid scientific data to support any claims outside of the above listed cleared claims/indications for infrared lamp devices and for the BioFind III. The FDA will evaluate this information and decide whether your products may be legally marketed.

Your promotion and introduction into interstate commerce of the BioFind III (or Biofind), BioPack II (or BioPack), Light Patch, Spinal Pad, and the Knee Saver for these uncleared indications render them adulterated under section 501 (f)(1)(B) of the Act, for failure to obtain FDA premarket approval, and misbranded under section 502(o) of the Act, for failure to notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act. For a product requiring premarket approval before marketing, the notification required by section 510(k) of the act is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency (21 CFR 807.81 (b)).

You should know that these serious violations of the law may result in the FDA taking regulatory action without further notice to you. These actions include, but are not limited to, seizing your product inventory, obtaining a court injunction against further marketing of the product, or assessing civil money penalties. In addition, United States federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts. Also, no requests for Certificates For Products For Export will be approved until the violations related to the subject devices have been corrected. It is necessary for you to take action on this matter now.

B. Violation of quality system regulation requirements

Additionally, for your information, on September 17, 25, and 26, 2002, an investigator from the FDA Albuquerque, New Mexico office conducted an inspection of your establishment located at 45 Dusty Trail Drive, Placitas, New Mexico 87043. The inspection revealed that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of these devices are not in conformance with the Quality System (QS) Regulation, as specified in 21 CFR, Part 820. These deviations from the QS Regulation cause your products to be adulterated within the meaning of section 501 (h) of the Act. Significant deviations include, but are not limited to, the following:

1. Failure to establish and maintain device master records (DMR) for the BioFind, BioPack, Light Patch, Spinal Pad, and Knee Saver devices, which include:
a. device specifications;
b. production process specifications;
c. quality assurance procedures and specifications;
d. packaging and labeling specifications and;
e. installation, maintenance and servicing procedures and methods; as required by 21 CFR 820.181.

2. Failure to establish and maintain device history records (DHR), for each batch, lot, or unit, to demonstrate that the device is manufactured in accordance with the DMR and the requirements of 21 CFR Part 820, as required by 21 CFR 820.184.

3. Failure to establish and maintain a quality system that is appropriate for the specific medical devices designed and manufactured by your firm, which includes:
a. quality policy;
b. organizational structure;
c. management review of the quality system;
d. a quality plan which defines the quality practices, resources and activities;
e. a quality system procedure; as required by 21 CFR 820.5 and 820.20.

4. Failure to establish procedures for quality audits, and to conduct audits to determine the effectiveness of the quality system and assure that it meets established requirements, as required by 21 CFR 820.22.

5. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, and for ensuring that complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR 803, Medical Device Reporting (MDR), as required by 21 CFR 820.198.

6. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100.

7. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30.

8. Failure to establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed, as required by 21 CFR 820.160.

9. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90.

10. Failure to establish and maintain procedures for identifying product during all stages of receipt, production, distribution and installation to prevent mix-ups, as required by 21 CFR 820.60.

11. Failure to establish and maintain procedures to control all documents specified by the Quality System regulation, as required by 21 CFR 820.40.

12. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.

This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violations noted in this letter and in the Form FDA 483 provided to your firm at the closeout of the inspection may be symptomatic of serious underlying problems in your firm’s manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violations identified by the FDA. If the causes are determined to be systems problems, you must promptly initiate permanent corrective actions. We have received a letter from you dated October 1, 2002, and letter from Mr. Peter J. Chase, dated March 3, 2003. The responses in these two letters are not adequate; they did not fully address or describe how you have corrected or will correct the noncompliances noted above.

Please let this office know in writing within 15 working days from the date you receive this letter, the steps you are taking to correct the problems. We also ask that you explain how you plan to prevent these deficiencies from occurring again. If you need more time, let us know why and when you expect to complete your corrections. Please address your response and any questions you may have regarding this letter to William H. Sherer, Compliance Officer, Food and Drug Administration, Denver District, P.O. Box 25087, Denver, CO 80225-0087, (303) 236-3051.

Sincerely,

/s/

B. Belinda Collins

District Director

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