Clinical Trials GPS Shares 2011 Q4 Findings; Almost 40% of Trials Aimed at Seniors, Less Than 17% Funded by The Government

Internal data shows a trend towards female participants, a surprisingly low volume of smokers, majority are willing to stay overnight, and an average age of 42.

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Pinnacle ENT Associates Receives Accreditation by the ICACTL

Pinnacle ENT Associates, LLC (PENTA), the largest independent Ear, Nose, Throat (ENT), Allergy and Audiology practice in the Philadelphia area, has been granted accreditation in the area of Sinus and Temporal Bone CT by the Intersocietal Commission for the Accreditation of Computed Tomography Laboratories (ICACTL).

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YourSaltLamps.com Marks Its One Year Anniversary With Introduction of New Himalayan Salt Lamp Special Package Deals for Huge Savings

YourSaltLamps.com, America’s Himalayan Salt Supersite, celebrates one year under new ownership as more and more consumers discover the benefits of Himalayan Salt Lamps and choose YourSaltLamps.com as their source for the highest quality Salt Lamps and top notch customer service!

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Conflict of interest rulings affect medical doctors

New conflicts of interest disclosures will broaden physicians’ reporting obligations.

Medical doctors face conflict of interest rules when they recommend dietary supplements to patients and profit from in-office sales of nutritional products.  (When Integrative Medicine Physicians Sell Dietary Supplements: Legal Issues).

But conflict of interest rules also apply to payments made to doctors for research, as well as for travel, consulting and speaking, and in other contexts.  New rules are likely to increase physicians’ disclosure obligations.

According to recent reports,

Officials said the disclosures increased the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.

Large numbers of doctors receive payments from drug and device companies every year — sometimes into the hundreds of thousands or millions of dollars — in exchange for providing advice and giving lectures.

… Under the new standards, if a company has just one product covered by Medicare or Medicaid, it will have to disclose all its payments to doctors other than its own employees. The federal government will post the payment data on a Web site where it will be available to the public.

Manufacturers of prescription drugs and devices will have to report if they pay a doctor to help develop, assess and promote new products — or if, for example, a pharmaceutical sales agent delivers $25 worth of bagels and coffee to a doctor’s office for a meeting. Royalty payments to doctors, for inventions or discoveries, and payments to teaching hospitals for research or other activities will also have to be reported.

Calls for increased transparency are part of health care reform:

The "Physician Payment Sunshine" provisions of the Affordable Care Act (ACA), require that drug, medical device, biologic, and medical equipment manufacturers that produce any products covered by Medicare or Medicaid or the Children’s Health Insurance Program must report all payments made to doctors and hospitals.

The government will post the financial relationship information on a public website where patients and anyone else can check what ties to the medical industry a given doctor has….

The law requires disclosure of payments for food, entertainment, gifts, consulting fees, honoraria, research funding or grants, education or conference funding, royalties or licenses, and charitable contributions.

Medical companies, as well as group purchasing organizations (GPOs), will also have to report stock ownership and investments held by doctors.

There are already existing legal obligations governing physician referrals to medical entities in which they have a financial interest.  The new rules add to these established self-referral and anti-kickback rules and also operate whether or not a referral is involved.

***

Michael H. Cohen is a thought leader in health care law, pioneering legal strategies and solutions for business law clients in traditional and emerging healthcare. wellness, and lifestyle markets.  As a corporate and regulatory attorney who has also handled litigation matters, Michael H. Cohen represents conscious business leaders in a transformational era. Clients seek Michael H. Cohen’s legal expertise on business structure and entity formation (corporations, partnerships, LLCs); health care licensing matters; employment contracts and independent contractor agreements; dispute resolution; e-commerce; intellectual property issues; informed consent and malpractice liability issues; HIPAA and confidentiality and privacy issues; Stark, self-referral, anti-kickback, patient brokering, and fee-splitting questions; dietary supplement labeling; medical device and FDA matters; insurance reimbursement and Medicare issues; website disclaimers; concierge medicine legal advice; telemedicine; and other business law and health care regulatory compliance arenas.  Whether advising start-ups or established companies, he brings his entrepreneurial spirit and caring insight to cutting-edge legal and regulatory challenges. Attorney Michael H. Cohen is admitted to practice law in California, Massachusetts New York, and Washington, D.C.  Contact our attorneys  firm today.

 


 

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Remedy For Knee Pain – Helpful Remedies For Knee Pain

Remedy For Knee Pain, Helpful Remedies For Knee Pain – We bend them, kneel on them, run and jump on them daily, yet few of us give them a second thought. Knees are  the most complex bodily part — and most injury-prone — joints in your body. Why? Unlike the more stable hip joint, which is a ball in a deeply-cushioned pocket, the knee joint is more exposed and more vulnerable.

Remedy For Knee PainRemedy For Knee Pain, Helpful Remedies For Knee Pain - As the knee straightens and bends, the kneecap slides up and down in the groove. The kneecap acts like pulley, increasing the power of the muscles attached to it. A tendon attaches the kneecap to the thigh muscles above, and a ligament connects it to the shinbone below.

What Causes Knee Pain?

Imagine, the knee cap as a puppet controlled by “strings”: muscles, tendons, and ligaments. As long as all of the strings pull in just the right way, the kneecap moves back and forth smoothly in its track. But if any string pulls not hard enough or too strongly, the kneecap is pulled out of its track and can no longer glide easily against the thighbone, which can cause pain and may even damage the kneecap.

The health and proper function of your knees depends on a number of factors including muscle strength, muscle flexibility, joint mobility, and gait pattern. If any one of these factors are compromised, you’ll be vulnerable to pain and injury.

If the supporting musculature of the knee joint is weak, more of the stress incurred by the knee will be transferred to its ligaments. Also if the major muscles that act on the knee are inflexible, it will increase the strain on the knee joint, the tendons attached to the muscles, and the muscles themselves. A lack of mobility in the hips and ankles will also increase the strain on the knee and exacerbate all of the problems listed above.

Remedies For Knee PainWhile knee problems can result from injuries such as falls, automobile accidents, and athletic injuries or diseases like osteoarthritis or arthritis. The vast majority of knee problems are caused from overstressing the knee, especially during strenuous physical activity such as running, climbing, or other repetitive, high-impact exercise. Poorly conditioned leg muscles also stress the knees.

Obesity is also one of the cause of knee pain. Carrying around a lot of excess weight puts additional pressure on the knees. Even a drop of ten to twenty pounds will make a big difference in the amount of strain that is put on the muscles of the knee. As an added incentive, the changes in diet and exercise required to effect a weight decrease will also provide a number of other health benefits for the body, including an increased ability to fight off inflammation in the joints.

Remedy For Knee Pain, Helpful Remedies For Knee PainPain in the knees is particularly a serious problem faced by the obese as well as older people. Sometimes it becomes so severe that it incapacitates people in bed. Age related wear and tear of the knee — known as Osteoarthritis(OA) is mainly responsible for this. Although common, many people are not aware of the solutions that are currently available. Proper medication, physiotherapy, lifestyle modification and sometimes surgery can help stop or lessen the pain.

Remedy For Knee PainIn Bangladesh, approximately 10 million people are suffering from Osteoarthritis. Women suffer more — 2 out of 3 women over the age of 65 have osteoarthritis. More than half of all men over the age of 65 have osteoarthritis. With the increasing longevity of life, the problem will multiply itself within a very short time. Osteoarthritis occurs when the knee undergoes age-related wear and tear around its joint. Almost every one is affected by it to some extent, as they grow older.

Osteoarthritis can also occur in weight bearing joints mainly hips and ankles. This form of arthritis slowly and gradually breaks down the overlying bony ends which forms the joint. With osteoarthritis, the smooth surface of bones becomes rough and pitted. In advanced stage it may wear away completely. Without the normal gliding surface the bones, eroded bones grind against one another causing pain, swelling, restricted knee motion, crispy sound inside the joint and sometimes bowing of the knees.

In addition to age related wear and tear, athletes, laborer and highly physically active persons often stress their knee joints that lead to prolong wear and tear, which places them at increase risk of developing arthritis.

Remedies For Knee PainArthritis has been linked with joint injuries and damaging events like fractures and infections that can harm the internal tissues of the joints. Individuals who experience repeated knee injuries are much more likely to develop osteoarthritis as they get older.

Lack of exercise can weaken the thigh muscles that support the knee joints, eventually making the under-used joint stiff, painful and dysfunctional. Lastly, heavy individuals are at increased risk of developing osteoarthritis, because their knees become strained by excessive weight. Research indicates that people who are overweight as young adults are likely to develop osteoarthritisof the knees as they age.

“When and how would I understand that I have osteoarthritis?” is a common question I face in my clinical practice. People start limping and the knee may become swollen with fluid. There may be a reduction in the range of motion of the affected knee — the knee bends less than normal and may lose the ability to completely straighten out. Finally, as the condition becomes worse, the pain persists all the time and may even keep you awake at night.

Repeated knee pain is the main symptom. It tends to be worse after activity. Knee stiffness occurs after rest, the joint feels stiff and it hurts to get going after sitting for any length of time. In time, the joint gets stiffer and you are unable to fully straighten or bend the joint. Knee swelling is also common especially after excessive activity. Knee bowing is seen if osteoarthritis is severe, your joint may become deformed what we call bowlegged.

Most people suffering from osteoarthritis can be treated by non-surgical means which include pain killer, physiotherapy, life style modification and injection in to the knees. Unfortunately if the medical measures are not successful in relieving pain, surgery may be considered. Among the surgical options, arthroscopic washout of the knees is relatively new method in Bangladesh used to relieve pain for sometimes.

When medical measures and arthroscopic washout fail; knees become progressively worsened both in pain and deformity, total knee joint replacement are the better option which is now being done in state-of-the-art hospitals under skilled care of experienced Knee Consultants.

While exercise may seem like a painful way to deal with knee pain, the fact is that stretching and working the muscles of the knee can have a beneficial effect in many cases. Strengthening the hamstrings with simple stretching exercises will help prevent the knee from freezing up. Since the knee depends a great deal on strong ligaments and muscles to operate properly, simple limbering exercises that are not done in excess can have a beneficial effect on knee pain. Before beginning any type of knee pain regimen, however, be sure to consult your physician and make sure the steps you have in mind are right for your condition.

Remedy For Knee Pain, Helpful Remedies For Knee Pain - Regular and correct exercising will help to strengthen the knee and also make it more flexible. Here are some easy exercises that you can do at home:

Knee extensions exercise

  • Remedy For Knee PainSit on a chair and keep a stool in front of you.
  • Place one leg on the stool. Hold the sides of the chair and gently press your knee toward the floor.
  • Hold the position for a few seconds and repeat again and then change legs and repeat the same way.
  • Do this ten times on each leg.
  • Now remove the stool and sit on the chair Raise one leg at a time and bring it down.
  • When the leg is lifted hold it for a few counts before bringing it down.
  • Repeat this exercise ten times on each leg and do it at least three times a day as it will help strengthen the knees.
  • Again while sitting on the chair; take a long towel and place it below the sole of one foot.
  • Gently pull the cloth from both ends so that your leg lifts up.
  • Hold this pose for a few counts and repeat on the other leg.
  • The leg must be raised not more than four inches off the ground. Again using the towel place it on the sole of the foot.
  • Hold the towel from the ends and try to straighten the knee by lifting the leg. Once the leg is outstretched push the sole of your foot on the towel for much as you can.
  • Repeat five to six times on each leg.

Remedy For Knee Pain, Helpful Remedies For Knee Pain - If these exercises are done regularly and correctly you will find tremendous improvement in your knee joints and the pain and swelling will be reduced considerably. As your knee joints get more flexible you can increase the amount of exercise you are doing.

Source: The Daily Star, by Dr. M. Ali

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Causes For Lower Back Pain – Beware Your Gait Causes For Lower Back Pain

Causes For Lower Back Pain - On a daily basis, you walk more than any other physical activity.  How you walk defines most everything about you, including predisposition to pain, athletic prowess, and health with respect to aging. Most people have something in their style of walking; i.e. an extreme foot turn-out, locked knees, a weak abdomen, that elicits imbalance in their body. The way you walk is in fact the actual culprit in why you have pain.

Causes for lower back painCauses For Lower Back Pain - Your walk involves several body parts, all interacting together to produce your style of head carriage, shoulder girdle, arm swing, hip movement, knee action, and the way you plant your foot. It’s as natural as breathing, and if any of your six (two ankles, two knees, two hips) weight bearing joints is just the tiniest bit askew, or crooked, you’re at risk for structural pain. Realize that one minor walking error repeated millions of times can do an incredible amount of damage to your muscles, nerves, and joints, eventually causing incredible pain. For your information, the average adult takes approximately 2500 steps per day per foot! That’s a lot of chances to either strengthen a joint and the muscles around it or wear them down!

A poor walking pattern can give rise to a host of problems affecting the spine and hips. Walking is an activity that comes so naturally that few ever give much thought to it. But a poor walking gait – due to injury, disease or poor habits – can throw the whole body out of balance. This could give rise to numerous problems affecting the back and hips.

Causes for lower back painWomen who wear high heels, for instance, are at risk of such problems. Wearing high heels places more stress on the forefoot and shortens the calf muscle.

The woman will also tend to arch her lower back, thereby increasing the natural ‘S’ shape of the spine. This makes it less effective at absorbing shock from the ground when walking, said Mr Paul Richards, a physiotherapist at Tan Tock Seng Hospital (TTSH). This is why some women suffer lower back pain after prolonged wearing of high heels.

The gait, or the pattern of movement of the limbs, is a repetitive motion cycle in which one leg gives the body support while the other swings forward and makes contact with the ground. The ideal gait is one which enables the body to move smoothly using the least amount of energy, said Ms Malia Ho, a podiatrist at Novena Medical Centre. This requires the cooperation of the whole body. Mr Richards said: ‘If one part of the body is not functioning properly, particularly in the lower limb area, the whole body can be thrown out of alignment.’

If left untreated, a misaligned gait can lead to aches and pains in the musculoskeletal system. A poor gait can result in an increased risk of injury, falls and a degenerative joint disease called osteoarthritis.

Chronic gait problems can also accelerate the degeneration of the spinal disc and cause arthritis in the spine, said Dr Tan Jee Lim, an orthopaedic surgeon at Gleneagles Medical Centre.

Causes for lower back painMs Melissa Phua, a senior podiatrist at TTSH, said: ‘The worst thing that can happen is when a poor gait causes injury and severe pain.’ Over time, ‘a poor gait increases energy expenditure and increases oxygen demand, which might reduce the person’s tolerance to activity’, said Mr Anirban Banerjee, a physiotherapist at National University Hospital.

Anyone who has ever had a stiff knee would understand how exhausting an abnormal gait can be. One has to swing the stiff knee outwards to clear the ground whereas a normal person would simply bend the knee, said Dr Tan.

Such swinging of the leg outwards requires an abnormal movement of the hip and spine which, on a prolonged basis, would give rise to hip and spine problems, he said. People with bow legs, knock knees and musculoskeletal trauma like broken bones are more likely to have a poor gait. Stroke patients who lose their ability to move their limbs also tend to have poor walking patterns.

Physiotherapists or podiatrists can help to improve their motion through physical therapy.

Causes for lower back painFlat feet can also be a risk factor for an abnormal walking gait. This is because the problem can affect the alignment of the feet and the way the knees move when a person walks, said Dr Jason Chia, head of the sports medicine and surgery clinic at TTSH.

Depending on the root cause of the poor gait, treatment may vary from strengthening exercises to assistive devices, such as those worn by people with flat feet to correct their arches and therefore their gait.

Common signs of a poor gait are pain or aches in certain joints during or after walking. ‘You may also feel that your foot, knee or hip is not moving in the way that it should,’ said Mr Robert Ashton, a podiatrist at a podiatry center in Forum The Shopping Mall.

The soles of one’s footwear could give clues about one’s gait. If the sole of one shoe is wearing out more than the other, it may point to an imbalance in the pressure exerted by the two feet, Mr Ashton said.

Causes For Lower Back Pain – It is important to keep one’s body in a well-conditioned state. This includes no slouching when walking, said Ms Phua. Mr Richards said regular stretches and exercises, like squats, can help to correct poor posture and muscle imbalances. ‘For older people, it may be helpful to do some simple simple balance training,’ he added.

Source: The Straits Times – by Jonathan Liautrakul

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Advantages Of Exercising – Exercise And Health Benefits

Advantages of exercising to your health benefits are hard to ignore. And the benefits of exercise are yours for the taking, regardless of your age, sex or physical ability.

Advantages of exercising – Want to feel better, have more energy and perhaps even live longer? Look no further than exercise. Need more convincing to exercise? Check out how exercise can improve your life.

Advantages of exercisingPhysical activity contributes to health by reducing the heart rate, decreasing the risk for cardiovascular disease, and reducing the amount of bone loss that is associated with age and osteoporosis. Physical activity also helps the body use calories more efficiently, thereby helping in weight loss and maintenance. It can also increase basal metabolic rate, reduces appetite, and helps in the reduction of body fat.

Exercise controls weight

Exercise can help prevent excess weight gain or help maintain weight loss. When you engage in physical activity, you burn calories. The more intense the activity, the more calories you burn. You don’t need to set aside large chunks of time for exercise to reap weight-loss benefits. If you can’t do an actual workout, get more active throughout the day in simple ways — by taking the stairs instead of the elevator or revving up your household chores.

Exercise combats health conditions and diseases

Worried about heart disease? Hoping to prevent high blood pressure? No matter what your current weight, being active boosts high-density lipoprotein (HDL), or “good,” cholesterol and decreases unhealthy triglycerides. This one-two punch keeps your blood flowing smoothly, which decreases your risk of cardiovascular diseases. In fact, regular physical activity can help you prevent or manage a wide range of health problems and concerns, including stroke, metabolic syndrome, type 2 diabetes, depression, certain types of cancer, arthritis and falls.

Exercise on Cancer

Advantages of exercisingA number of studies have indicated that regular, even moderate, exercise may reduce the risk of colon cancer and, in fact, any cancer related to obesity. A number of studies have also suggested that regular exercise, particularly if it is vigorous, reduces risks against breast cancer in women and prostate cancer in men. Indeed, a 2004 study showed that prostate cancer cells have a 27% reduction in growth when exposed to exercise serum (blood serum taken from patients who exercise) compared to control serum, suggesting that exercise changes blood chemicals to be less hospitable to cancer cells.

Several studies are underway to measure the effect of exercise on patients who have been diagnosed with cancer. Even though preliminary, they already suggest that exercise has a positive physical, mental, and emotional effect. Exercise can improve physical strength, functional capacity, and the ability to battle the negative side effects of chemotherapy, including nausea and fatigue. More studies are warranted.

Exercise improves cardiovascular health

Cardiovascular health – Lack of physical activity is one of the major risk factors for cardiovascular diseases. Regular exercising makes your heart, like any other muscle, stronger. A stronger heart can pump more blood with less effort.

Advantages of exercisingCholesterol lowering effect – Exercise itself does not burn off cholesterol like it does with fat, however, exercise favorably influences blood cholesterol levels by decreasing LDL (bad) cholesterol, triglycerides and total cholesterol and increasing HDL (good) cholesterol.

Blood pressure lowering – The way in which exercise can cause a reduction in blood pressure is unclear, but all forms of exercise seem to be effective in reducing blood pressure. Aerobic exercise appears to have a slightly greater effect on blood pressure in hypertensive individuals than in individuals without hypertension.

Reduced risk of stroke – Research data indicates that moderate and high levels of physical activity may reduce the risk of total, ischemic, and hemorrhagic strokes.

Exercise help control and prevent diabetes

Scientists and doctors have already proven that there is strong evidence that moderate physical activity combined with weight loss and a balanced healthy diet result in improved insulin resistance and a lower risk of diabetes by 50-60%. Now a new study, conducted by UCLA scientists, suggests that their may be a correlation between increasing muscle mass and lowering insulin resistance.

Exercise improves balance and prevent falls in elderly

Advantages of exercising

  • Exercise improves Muscle strength

    Health studies repeatedly show that strength training increases muscle strength and mass and decreases fat tissue.

  • Exercise improves Bone strength

    An active lifestyle benefits bone density. Regular weight-bearing exercise promotes bone formation, delays bone loss and may protect against osteoporosis – form of bone loss associated with aging.

Exercise improves the Gastrointestinal Tract

Endurance athletes often report gastrointestinal distress, such as bloating, diarrhea, and gas, even at rest. Experts suggest, however, that moderate regular exercise, might reduce the risk for some intestinal disorders, including ulcers, irritable bowel syndrome, indigestion, and diverticulosis. For example, in one 2000 study, exercise was associated with a lower risk for ulcers in men (although not in women.) Older people who exercise moderately may have a lower risk for severe gastrointestinal bleeding.

Exercise lower Neurologic Diseases and Mental Decline

Advantages of exercisingA 2001 study reported that older people who regularly exercised had lower rates of mental deterioration, Alzheimer’s, and dementia of any type. Aerobic exercise is linked with improved mental vigor, in all people, including reaction time, acuity, and math skills. Exercising may even enhance creativity and imagination. According to one study, older people who are physically fit respond to mental challenges just as quickly as unfit young adults. Another study found that walking regularly protects women from mental decline, and in fact, the more they walked per week, the more protection they enjoyed. (Stretching and weight training appear to have no such effects.) A 2004 study showed that exercise can reverse a high-fat diets harmful effects on neurologic function.

Exercise improves mood

Need an emotional lift? Or need to blow off some steam after a stressful day? A workout at the gym or a brisk 30-minute walk can help. Physical activity stimulates various brain chemicals that may leave you feeling happier and more relaxed. You may also feel better about your appearance and yourself when you exercise regularly, which can boost your confidence and improve your self-esteem.

Advantages of exercisingExercise boosts energy

Winded by grocery shopping or household chores? Regular physical activity can improve your muscle strength and boost your endurance. Exercise and physical activity deliver oxygen and nutrients to your tissues and help your cardiovascular system work more efficiently. And when your heart and lungs work more efficiently, you have more energy to go about your daily chores.

Exercise promotes better sleep

Struggling to fall asleep? Or to stay asleep? Regular physical activity can help you fall asleep faster and deepen your sleep. Just don’t exercise too close to bedtime, or you may be too energized to fall asleep.

Exercise puts the spark back into your sex life

Advantages of exercisingDo you feel too tired or too out of shape to enjoy physical intimacy? Regular physical activity can leave you feeling energized and looking better, which may maintains or improves sex life. But there’s more to it than that. Physical improvements in muscle strength and tone, endurance, body composition and cardiovascular function can all enhance sexual functioning in both men and women. Regular physical activity can lead to enhanced arousal for women. Researchers revealed that men who exercise regularly are less likely to have erectile dysfunction and impotence than are men who don’t exercise.

Exercise benefits on Pregnancy

Advantages of exercisingGood regular exercise during pregnancy can reduce the time of your labor, improve the outcome of your pregnancy and decrease the risk of complications including low-birth weight babies. This not only helps you but your child as well as exercising increases the fetal heart rate, which in turn protects the baby.

The benefits of prenatal exercise are many. For instance, you’ll get a better posture and reduce discomforts and pains such as backaches or tiredness. But keep in mind, you should not exercise at the same rate you did before your pregnancy. At the most you should do only low-impact exercise such as yoga, pilates or easy aerobics.

Healthy women with normal pregnancies should exercise at least three times a week, being careful to warm up, cool down, and drink plenty of liquids. Many prenatal calisthenics programs are available.

Specific exercises may be particularly beneficial:

Aerobics. Either brief periods of intense training or prolonged aerobic workouts can raise chemicals in the brain, such as endorphins, adrenaline, serotonin, and dopamine, that produce the so-called runners high. And, of course, weight loss and increased muscle tone can boost self-esteem.

Advantages of exercisingYoga. Yoga practice, which involves rhythmic stretching movements and breathing have been found to positively affect mood and may have clinical potential as a technique for improving and stabilizing mood. One study, in fact, suggested that men actually may have better results with yoga than with aerobic exercise. In the study men experienced significantly lower levels of tension, fatigue, and anger after yoga than after swimming. (Yoga and swimming tended to produce equal benefits in women.)

Advantages of exercising and physical activity are a great way to feel better, gain health benefits and have fun. As a general goal, aim for at least 30 minutes of physical activity every day. If you want to lose weight or meet specific fitness goals, you may need to exercise more. Remember to check with your doctor before starting a new exercise program, especially if you have any health concerns.

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Coordinated government efforts target health care fraud and abuse

Coordinated government enforcement targets fee-splitting, Stark and kickback fraud and abuse in health care.

Each day there are new reports of health care fraud enforcement actions, both under Medicare and state law.  It is much easier to find and go after health care fraud and abuse than ever:

… in 1996, the federal government broadened the Health Insurance Portability and Accountability Act of 1996 [HIPAA] to extend criminal penalties to inducements to refer to any federal healthcare insurance program, including insurers and providers. Congress enacted Title 18, United States Code, Section 1347, which, for the first time, specifically criminalized any scheme to defraud a healthcare benefit program. By 1998, DOJ began to establish both criminal and civil healthcare fraud coordinators in all ninety-four U.S. Attorneys’ offices, beginning the trend to unify and standardize national healthcare investigations and prosecutions.

After a modest increase in healthcare costs in the mid-1990s, from 1999 through the first ten years of the twenty-first century, healthcare costs doubled in addition to growing again at twice the GDP.7 Again, much attention was focused on eliminating fraud from the national healthcare system. This time, with the underlying legal fabric in place, federal law enforcement established a unified, focused team of investigators and prosecutors to combat the problem. This tactic was new to healthcare prosecution, but had been effective in many other areas.

Modern computerized methods make it ever easier to conduct health care fraud investigations:

The philosophy was simple: analyze current billing data to find outliers—providers who were billing Medicare such exorbitant amounts that the only legitimate explanation was a fraudulent one… The data comes in many forms including provider claims, cost reports, prescription data, US. Securities and Exchange Commission, nonprofit, and UCC filings, among a myriad of other sources. Investigators analyze it in many ways through data queries, correlations, and trend analysis (by provider type, CPT code, locations, etc.). They perform peer  comparisons, statistical sampling, and conduct “impossible days” analyses—where providers billed for more than twenty-four hours of work in one day. They look for double billing and upcoding (billing for a more expensive service when a less expensive one was actually performed). These analyses help determine whether fraud is evident and if an investigation is warranted. 

(P. Katz, Medicare Strike Force).  

So it is no surprise that our law office is increasingly inundated with calls from various health care practitioners under investigation for various forms of health care fraud and abuse.  Some are medical doctors and osteopaths, while others are dentists, psychologists, nurses, or other kinds of health care professionals.

Practitioners are often unaware of how they have come to the attention of enforcement authorities or what they might have done to trigger an investigation.

We also receive calls about Stark / self-referral, fee-splitting, and anti-kickback concerns from healthcare providers, institutions, and corporate entities as well as from entrepreneurs interested in launching multidisciplinary or other joint ventures.  For example, we represent physicians who want to contract with chiropractors in professional medical corporations; practitioners of acupuncture and traditional oriental medicine; massage therapists; naturopathic doctors and naturopaths; herbalists; practitioners of homeopathy and physician homeopaths; healers; and others who want to know whether they could be engaging in illegal splitting or can find more legitimate ways of structuring their businesses.

All this enforcement activity also is increasing in the areas of unlicensed practice and scope of practice.  Boards of medicine, nursing, psychology, and nutrition in particular are looking to investigate practitioners for unlicensed practice of medicine, unlicensed practice of psychology, and unlicensed practice of nutrition.  Practitioners who use touch but do not have a massage therapy license can also be at risk of unlicensed practice charges. 

And because the legal definitions of "diagnosis" and "treatment" are often interpreted so broadly, even licensed practitioners often find themselves under investigation by an enforcement agency for crossing the line into practice of medicine without a license, which is usually defined as a criminal activity.

More recently, we have represented clients under investigation for violation of laws relating to licensing of laboratories and laboratory tests.  Many are unaware of the federal Clinical Laboratory Improvements Act (CLIA) and of the need for CLIA certification or a CLIA waiver – particularly as these legal rules affect tests that are considered complementary or alternative to more accepted medical tests; or of state laws that track CLIA in terms of establishing parallel compliance parameters.

It is important to seek legal advice from a healthcare lawyer who knows the legal and regulatory enforcement landscape.  Federal law as well as state law can apply and the penalties can be severe. In many cases, there are coordinated enforcement efforts across agencies.

In addition, aiding and abetting charges can be brought to those who are helping practitioners engage in unlicensed practice.  Sometimes the activity might be thought of as innocent, but the practitioner or entrepreneur must understand that simply ‘splitting the fee’ and pocketing the difference can have legal consequences, as can hiring a practitioner who is trying to fit under a legal umbrella for non-licensed practice but engages in methods that can cross legal lines.

If you have questions about regulatory enforcement activities concerning multidisciplinary practices or healthcare enterprises involving a variety of disciplines, you may wish to consult our video resources or other materials, including legal references on this blog.

***

Michael H. Cohen is a thought leader in health care law, pioneering legal strategies and solutions for business law clients in traditional and emerging healthcare. wellness, and lifestyle markets.  As a corporate and regulatory attorney who has also handled litigation matters, Michael H. Cohen represents conscious business leaders in a transformational era. Clients seek Michael H. Cohen’s legal expertise on business structure and entity formation (corporations, partnerships, LLCs); health care licensing matters; employment contracts and independent contractor agreements; dispute resolution; e-commerce; intellectual property issues; informed consent and malpractice liability issues; HIPAA and confidentiality and privacy issues; Stark, self-referral, anti-kickback, patient brokering, and fee-splitting questions; dietary supplement labeling; medical device and FDA matters; insurance reimbursement and Medicare issues; website disclaimers; concierge medicine legal advice; telemedicine; and other business law and health care regulatory compliance arenas.  Whether advising start-ups or established companies, he brings his entrepreneurial spirit and caring insight to cutting-edge legal and regulatory challenges. Attorney Michael H. Cohen is admitted to practice law in California, Massachusetts New York, and Washington, D.C.  Contact our attorneys  firm today.

 


 

 

 

 

 

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He’s Back: Aesthetic VideoSource Presents -Thai Acupressure Massage- DVD Set

Dr. Anthony James, CMT, DPM, ND, MDAM, SMOKH, the top instructor in the United States, demonstrates how to provide a complete Thai acupressure massage treatment for the feet, hands, and face, all on a massage table and on a traditional Thai mat.

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Anti-Aging Breakthrough Presented at Leading Medical Conference

Health Expert, Dr. Isaac Eliaz, discussed new evidence on the positive effects of Modified Citrus Pectin in blocking unhealthy levels of Galectin-3 molecules in the body at a recent conference.

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