HR 4209 IH

 112th CONGRESS

 2d Session

H. R. 4209

 To amend title XXVII of the Public Health Service Act to limit co-payment, coinsurance, or other cost-sharing requirements applicable to prescription drugs in a specialty drug tier to the dollar amount (or its equivalent) of such requirements applicable to prescription drugs in a non-preferred brand drug tier, and for other purposes.

 IN THE HOUSE OF REPRESENTATIVES

 March 19, 2012

Mr. MCKINLEY (for himself, Mrs. CAPPS, Mr. YOUNG of Florida, Mr. CUELLAR, and Mr. FRANK of Massachusetts) introduced the following bill; which was referred to the Committee on Energy and Commerce

A BILL

To amend title XXVII of the Public Health Service Act to limit co-payment, coinsurance, or other cost-sharing requirements applicable to prescription drugs in a specialty drug tier to the dollar amount (or its equivalent) of such requirements applicable to prescription drugs in a non-preferred brand drug tier, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Patients’ Access to Treatments Act of 2012’.

SEC. 2. CO-PAYMENT, COINSURANCE, AND OTHER COST-SHARING REQUIREMENTS APPLICABLE TO PRESCRIPTION DRUGS IN A SPECIALTY DRUG TIER.

(a) In General- Subpart II of part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg et seq.) is amended by adding at the end the following:

‘SEC. 2719B. CO-PAYMENT, COINSURANCE, AND OTHER COST-SHARING REQUIREMENTS APPLICABLE TO PRESCRIPTION DRUGS IN A SPECIALTY DRUG TIER.

• (a) Requirement- A group health plan, or a health insurance issuer offering group or individual health insurance, that provides coverage for prescription drugs and uses a formulary or other tiered cost-sharing structure shall not impose co-payment, coinsurance, or other cost-sharing requirements applicable to prescription drugs in a specialty drug tier that exceed the dollar amount (or its equivalent) of co-payment, coinsurance, or other cost-sharing requirements applicable to prescription drugs in a non-preferred brand drug tier (or prescription drugs in a brand drug tier if there is no non-preferred brand drug tier).
• (b) Special Rule- If a formulary used by a group health plan or a health insurance issuer offering group or individual health insurance contains more than one non-preferred brand drug tier, then the requirements of subsection (a) shall be applied with respect to the non-preferred brand drug tier for which beneficiary cost-sharing is lowest.
• (c) Definitions- In this section:

(1)  The term ‘prescription drug’ means–

• (A) a drug subject to section 503(b)(1) of the Federal Food, Drug, or Cosmetic Act; and
• ‘(B) includes a drug described in subparagraph (A) that is a biological product (as defined in section 351(i) of this Act).

(2) The term ‘non-preferred brand drug tier’ means, with respect to a group health plan or health insurance issuer offering group or individual health insurance coverage that uses a formulary or other tiered cost-sharing structure, a category of drugs–

• (A) within a tier in such formulary for which beneficiary cost-sharing is greater than tiers for generic drugs or preferred brand drugs in the plan’s formulary;
• (B) that are prescription drugs; and
• (C) that are not included within a specialty drug tier.

(3) The term ‘specialty drug tier’ means, with respect to a group health plan or health insurance issuer offering group or individual health insurance coverage that uses a formulary or other tiered cost-sharing structure, a category of drugs–

• (A) within a tier in such formulary for which beneficiary cost-sharing is greater than tiers for generic drugs, preferred brand drugs, or non-preferred drugs in the plan’s formulary; and
• (B) that are prescription drugs.

(b) Effective Date- Section 2719B of the Public Health Service Act, as added by subsection (a), applies to plan years beginning on or after the date of the enactment of this Act.

This is just how it works with me, sometimes I won’t have any pain whatsoever and instead my sinus will go nuts.  I tracked my symptoms for over 5 years and found that my symptoms would appear and disappear without any warning much like my pain levels did when I was having flare, not like a sinus infection or allergy attack.  Anyway, when there is an interruption in my sleep patterns, or a disruption in my routine I will have a fibromyalgia flare.  It’s been over a year since I have had a major flare and I guess it was time.  The Brain Wave Entertainment that I usually do wouldn’t cut all of my pain, although it did reduce it considerably, so I turned to something called Emotional Freedom Technique.

I’ve researched this alternative method for several years and decided to give it a try.  I bought several books on the subject and attended the 2012 Tapping Summit over the past several days to learn all I could about it.

EFT is based on the discovery that imbalances in the body’s energy system have profound effects on one’s personal psychology and that by correcting these imbalances, which is done by tapping on certain body locations, will often lead to rapid remedies.  I know, I know, it sounds kind of hooky, like Brain Wave Entertainment, but it’s better than taking 3 kinds of pain pills and then having to take several other pills to counteract the side effects of those pills.  Did that, been there, wrote the book on it!!

I am going to document my results on here for you so that you can see if it works or it doesn’t.  There are many reasons why we have pain and getting to the bottom of those reasons will some time.  How much time?  I really can’t say.  I do know that there are case histories where EFT has taken several hours to several days.  I will also give you more information on the process and techniques to use for yourself.

Category:Health economics (Photo credit: Wikipedia)

I attended the Arthritis Foundation‘s Advocacy Summit on April 16 – 18, 2012 because I am both an advocate and an ambassador to Congress.  I must say it was enlightening.  Before I went to Washington I did some research into each of my Senators and my Representative to see how they voted on health issues  and what their views were on health care reform.  I’m still new at this and really don’t have any idea of how our government works but I can say that the bills that would help us, the people of the United States, will sit in the Senate for years with no votes on them at all until they “die” or they are mixed in with other issues that have nothing to do with health care and again they “die” because they aren’t what these people think you and I want.  This is my opinion only.

The priorities of the Arthritis Foundation are as follows:

Access To Care                                                                                                         

House Key message:  Co-Sponsor the Patients’ Access to Treatments Act of 2012 (H.R. 4209)                                           Senate Key message:  Become a lead Senate sponsor of the Patients’ Access to Treatments Act of 2012

• Improves access to medications, which can prevent disability.
• Will end the discrimination and excessive cost-sharing of these arthritis medications.
• H.R. 4209, the Patients’ Access to Treatments Act of 2012 (PATA) is a bi-partisan legislation introduced by Representatives McKinley (R-WV) and Capps (D-CA).

Support $5 million for the Pediatric Sub-specialty Loan Repayment Program

• Arthritis is a disabling and painful disease that affects 300,000 children.  That’s nearly 1 in 250 children are living with a form of arthritis known as Juvenile arthritis.  It is one of the most common childhood diseases, affecting more children than cystic fibrosis and muscular dystrophy.
• Right now there are less than 250 pediatric rheumatologist in the US and about 90% of those are clustered in and around large cities.
• The President’s Fiscal Year 2013 budge is requesting $5 million to fund the Pediatric Sub-specialty Loan Repayment Program at the Health Resources and Services Administration (HRSA), which would help ease the shortage and poor distribution of practicing pediatric rheumatologist.  We are asking Congress to support this budget.

RESEARCH

 Include ”post traumatic osteoarthritis” and “rheumatoid arthritis” research at the Congressionally Directed Medical Research Program (CDMRP) at the Department of Defense (DoD)

• Supporting DoD research will help reduce the arthritis burden on our Nation’s soldiers, veterans and civilians.
• Veterans have twice the rate of osteoarthritis as non-veterans.
• OA is one of the leading causes of disability and medical discharge in active service members under the age of 40.

Increase research at NIH

• Increased research funding at the National Institutes of Health (NIH) holds the key to preventing, controlling and curing arthritis, the nation’s  leading cause of disability.
• The critical research done at NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) improves the quality of life or people with arthritis and decreases the overall burden of the disease.
• NIH funding should be allocated $32 billion for the Fiscal Year 2013 and $559 million to fund critical research on arthritis and other related diseases at the Institute.    (Right now there is about $2 million (give or take a few million) being spent on Fibromyalgia research)

PREVENTION

Support the CDC Arthritis program with an extra $10 million in funding

• There are over 50 million Americans who are affected by arthritis, federal funding for programs that address the prevention and control of arthritis must stay a national public health priority.
• Increased funding for the CDC Arthritis program to $23 million to expand the program to more states.

As of today the CDC Arthritis program is in 12 states and Georgia isn’t one of them.  I found this kind of strange because the CDC is in Atlanta, GA.

All of these priorities are extremely important in the fight to find a cure for Arthritis and I will go into greater depth about each because I want you to understand just what this means to you.

I am one of many of the Arthritis Foundation‘s Ambassadors to Congress and I’ve tried to get through their training and babysit with a most adorable little boy, and of course it’s tax time and I’ve had to get things ready for the accountant my husband has do our taxes every year (to complicated for either of us), and do the research for the articles I write, and then write my articles so that you may have the information to help you to cope or change your arthritis and fibromyalgia problems.  Then several weeks ago my computer crashed and I lost all the research I had already done along with every article I had ever written.  I hadn’t been able to back anything up because my computer wouldn’t let me.

Any way all is well now I will have a new article for you by Monday the 6th of February and I’ll have one new article each week for you.

It seems that my life has suddenly taken a turn and I am busier than usual.

I love y’all.

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Researchers working on the puzzle of fibromyalgia syndrome (FMS) are adding more and more pieces.  While we don’t yet have a complete picture, we’re getting closer.  Many experts believe the condition is brought on by complex, abnormal responses to stress and could be linked to a genetic predisposition.  Studies also show, with FMS, the parts of your brain and central nervous system that deal with pain signals work differently from other people’s.  This is called central sensitization.

Experts are learning a lot about what leads to FMS, but they’re still not clear on why these things lead to FMS in some and not in others.

Fibromyalgia is grouped into two categories — primary and secondary. Primary FMS is the most common and is also called “idopathic” FMS, meaning it has an unknown cause.  Secondary FMS is associated with other conditions.

PRIMARY (IDIOPATHIC) FIBROMYALGIA

Suspected causes of primary FMS include chronic sleep disturbance, abnormalities in brain chemicals and hormones, psychological and social effects, and muscle abnormalities.   Some researchers are looking at nitric oxide levels.

• Chronic sleep disturbance                                                                                                                                                                 Sleep disturbances and fibromyalgia go hand in hand, and some experts believe sleep disturbances come first.  You can have restless leg syndrome, periodic limb movement disorder (PLMD) and sleep-related breathing disorders.                                                                                                                                                                                                                  In one study, people with FMS had faster rates of cyclic alternating sleep pattern (CAP), which leads to a non-refreshing sleep.  Researchers concluded the increased rate leads to serious sleep problems that make FMS symptoms worse.                                                                                                                                                                                            Some sleep problems of FMS may be linked to levels of the nervous-system chemicals serotonin and melatonin, which help regulate sleep-and-waking cycles.

• Brain chemical & hormonal abnormalities                                                                                                               Researchers know when you have fibromyalgia you can have many abnormalities in your hormonal, metabolic and brain-chemical activity, but they’re not sure whether these are causes of fibromyalgia or the effect of pain and stress on the central nervous system.  If you have FMS you may have imbalances in any of the following brain chemicals:

 Serotonin: low levels

Serotonin impacts your sleep cycle, pain level and feelings of well-being.  Low levels are linked to depression, migraine and irritable bowel syndrome, all of which often occur in people with FMS.

Melatonin: low levels

Your body makes melatonin from serotonin.  Typically, serotonin levels increase in the morning to help you wake up, then drop at night as your body converts it into melatonin, which helps you sleep.  Some studies show taking melatonin supplements can cut pain levels, improve sleep and improve depression symptoms in people with FMS.  But then again there are other studies showing little or no improvement.

Stress hormones: low levels

Deficiencies in the stress hormones cortisol and norepinephrine make your body less able to cope with psychological or physical stress. (Physical stress includes infection or strenuous activity.)

IGF-1 growth hormone: low levels

This hormone promotes bone and muscle growth.  Low levels are related to problems with thinking, low energy, muscle weakness an intolerance to cold.  This level may be a marker of FMS rather than a cause.

Substance P: high levels

Substance P is a chemical messenger in the nervous system associated with pain perception.  If you have too much, your brain gets too many pain signals.  People with FMS can have up to three times the normal amount in their spinal fluid.

Abnormal pain perception: high activity levels

Some studies and brain scans suggest fibromyalgia patients have too much activity in the parts of the brain and central nervous system that process pain.

Researchers are working to understand what these abnormalities mean and how this knowledge can lead to treatments.

•  Psychological & social effects                                                                                                                                                 According to studies, people with FMS are more likely than others to have experienced severe emotional and physical abuse.  This suggests that post-traumatic stress disorder (PTSD) or chronic stress could play a strong role in the development of FMS in some people.  Evidence shows that PTSD actually leads to changes in the brain, possibly from long-term over-exposure to stress hormones.

• Muscle abnormalities                                                                                                                                                                            Though these things can’t be tested at your doctor’s office or clinic, some research has shown that people with FMS have three kinds of muscle abnormalities:

 Biochemical

 Some FMS patients have low levels of muscle-cell chemicals that make sure you have enough calcium in your muscles.  When levels are low, the muscles stay contracted rather than relaxing.

 Structural & blood flow

 Researchers have found people with FMS have especially thick capillaries (tiny blood vessels). This could mean your muscles don’t get enough oxygen-rich blood or other compounds you need for proper muscle function.

 Functional

 Experts don’t know why this is but speculate that the pain and stress of the disease itself may harm muscle function.

Sources:

2007 About, Inc., a part of the New York Times Company. All rights reserved. “Fibromyalgia”

2007 ProHealth, Inc. All rights reserved. “Melatonin Deficiencies in Women”

1995-2007 Life Extension Foundation. All rights reserved. “Fibromyalgia”

SECONDARY FIBROMYALGIA

Secondary fibromyalgia appears either after or at the same time with other medical problems, usually one of the following:

•  Physical injury, especially to the neck
• Ankylosing spondylitis (arthritis that affects the spine)
• Surgery
• Lyme disease (May trigger FMS even after Lyme has been treated)
• Hepatitis C (some studies hint at this association)
• Endometriosis

When there’s another condition at work, it can give doctors a real a challenge when it comes to diagnosing secondary FMS.  First, it can be difficult to sort out what condition is causing what symptoms.  Second, FMS is considered a diagnosis of exclusion because anything reversible has to be treated before a doctor can diagnose it.

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There are more than 6-million people in the U.S. alone who have fibromyalgia syndrome (FMS), and the condition reaches all cultures around the world.  Anyone can get it, but some people are more at risk than others.

What are the risk factors?

Both men and women can develop FMS, although between 80 and 90% diagnosed with it are women.  Experts don’t know why, but some believe it could be tied to a hormonal difference.  It seems that most men are less likely to seek treatment or even admit they could have it, and therefore aren’t diagnosed as often as women.

It’s most common in people between 20 and 55, and women are most likely to develop it during their childbearing years, but, older people also can develop Fibromyalgia.  Children can, but rarely do.  So it can be said that Fibromyalgia knows no age.

Research shows that women closely related to a fibromyalgia sufferer is more likely to develop FMS themselves, indicating a possible genetic defect that predisposes some people from the beginning.

• Sleep Disorders:                                                                                                                                                                                               Some experts say sleep disorders could be a cause of fibromyalgia.  If you have a long history of sleep problems, and if you have been diagnosed with disorders such as sleep apnea you may have an increased risk.  Some doctors recommend sleep studies for their fibromyalgia patients.
•  Stress                                                                                                                                                                                                                         If you are always in stressful environments or you are particularly vulnerable to stress (either physiological or psychological) you can develop FMS more often that those affected less by stress.  Studies have suggested that post-traumatic stress disorder (PTSD) or chronic stress may play a strong role in the development of fibromyalgia.  High stress levels are also known to trigger flare-ups if you have FMS.  Studies also show low cortisol (stress hormone) levels and dysfunction in the HPA axis, which deals with physiological reactions to stress can trigger fibromyalgia.
•  Scoliosis/Low Back Pain:                                                                                                                                                                          In one study, about 25% of people with low back pain eventually developed FMS, and scoliosis or other postural disorders made FMS more likely.  Other research confirms the link between scoliosis and FMS.  Interestingly, low levels of melatonin, which can cause sleep disorders, are also believed to contribute to scoliosis.
•  Joint Hyper-mobility                                                                                                                                                                                            Some research shows that if your joints bend beyond the normal range (“double jointed”) you are more likely to develop fibromyalgia, possibly because you’re more prone to repeated minor injuries.
• Other chronic-pain conditions:                                                                                                                                                                  If you suffer with frequent headaches/migraines, lupus, osteoarthritis, rheumatoid arthritis and ankylosis spondylitis (a type of arthritis) you have an increased risk for developing FMS, possibly because your chronic pain causes desensitization of the central nervous system, which is believed to be the cause of FMS pain.

Lowering Your Risk

You can’t do much to stop most of these risk factors, but, if you feel you’re at risk you can work to effectively lower or manage your stress. You might be able to lower your risk (and improve your life) by getting regular exercise, eating a healthy diet, and getting proper medical treatment for pain, sleep disorders, past emotional trauma, or PTSD.

Sources:

2007 About, Inc., A part of The New York Times Company. All rights reserved. “Fibromyalgia”

Gerwin RD.A review of myofascial pain and fibromyalgia — factors that promote their persistence.

Lapossy E, et al.The frequency of transition of chronic low back pain to fibromyalgia.

Machida M, et al.Serum melatonin levels in adolescent idiopathic scoliosis prediction and prevention for curve progression — a prospective study.

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Introduction

Fibromyalgia is a syndrome of unknown causes that results in lasting, sometimes debilitating, muscle pain and fatigue. Fibromyalgia is also known as fibrositis or fibromyositis.

General Description of Fibromyalgia Symptoms

Pain.

The primary symptom of fibromyalgia is pain. The pain can be in one place or all over the body. The exact locations of the pain is called tender points. Fibromyalgia pain is often described as:

• Tender point pain that occurs in local areas, usually in the neck and shoulders.                                                                                                                                            The pain then spreads out from these areas.  The actual pain starts at the muscles.  The joints are not affected. There are no lumps or nodes associated with these pain points, and no signs of inflammation (swelling).  You have  fibromyalgia when you feel pain in at least 11 of 18 specific tender points.
• Widespread stiffness, burning, and aching pain.                                                                                                                   The pain also “radiates,” or spreads, to nearby areas. You always feel some pain all the time. You may describe it as “exhausting.”  The pain can vary depending on the time of day, changes in the weather, physical activity, and if you happen to be experiencing anything stressful in your life at the time.  The pain is often more intense after you have been woke up before you are ready.

Fatigue and Sleep Disruptions.

Another major fibromyalgia complaint is fatigue. Your fatigue is more distressing than your pain. Sleep disruptions, specifically restless legs syndrome, is also very common. Fatigue and sleep disruptions are almost universal when you have fibromyalgia. Some experts believe that if these symptoms are not present, the condition may not be fibromyalgia.

Depression and Mood.

Up to a third of you will have depression. Disturbances in mood and concentration are also very common and often go undiagnosed.

Other Symptoms.

You might experience the following symptoms as well:

• Digestive problems, including irritable bowel syndrome with gas, and alternating diarrhea and constipation
• Dizziness
• Painful menstrual periods
• Tension or migraine headaches
• Tingling or numbness in the hands and feet
• Urinary frequency caused by bladder spasms

Symptoms in Children.

In general, children with fibromyalgia most often have sleep disorders and widespread pain.

Causes

In the most common type of fibromyalgia, the causes are not known. Physical injuries, emotional trauma, or viral infections such as Epstein-Barr may trigger the disorder, but no one trigger has proven to be a cause of primary fibromyalgia.

Many experts believe that fibromyalgia is not a disease, but is rather a chronic pain condition brought on by several abnormal body responses to stress. Areas in the brain that are responsible for the sensation of pain react differently when you have fibromyalgia than the same areas in healthy people.

People with fibromyalgia have been found to have decreased activity in opioid receptors in parts of the brain that affect mood and the emotional aspect of pain. This reduced response might explain why fibromyalgia patients are likely to have depression, and are less responsive to opioid painkillers, researchers say.

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Key Points:

Causes

Researchers have discovered an unusual increase in blood flow (called “brain per-fusion”) in an area of the brain that separates pain intensity, and a decrease in blood flow in areas thought to be associated with the emotional response to pain after using brain scans. These differences have nothing to do with your depression and anxiety levels. Therefore the research supports the idea that fibromyalgia is a real disorder, and isn’t a result of depression.

You seem to be more sensitive to sounds than those without the condition. This increased sensitivity may be due to an irregularity in the sensory processing by the central nervous system.

Prognosis

You experience a greater psychological upset and fibromyalgia has a greater impact on your quality of life than those with other conditions, such as chronic low back pain.

Treatment

The U.S. Food and Drug Administration (FDA) has approved the drug duloxetine (Cymbalta) for treating fibromyalgia. In studies, duloxetine reduced fibromyalgia pain by more than 30%.

Lifestyle

Exercising in a warm swimming pool is a cost-effective therapy that improves quality of life in women with fibromyalgia.

Waon therapy may help reduce the pain of fibromyalgia, according to one small study. Below you will find the details of that study.

Waon Heat Therapy for Fibromyalgia

A recent article from Japanese researchers has shown that Waon Therapy, a specific kind of soothing warmth therapy, can be effective at helping to treat Fibromyalgia Syndrome (Fibro).

For the Waon therapy, 13 women with Fibromyalgia, spent 15 minutes relaxing in an infrared-ray dry sauna controlled at an even temperature of 60 degrees C, then they were moved to a room controlled at 26-27 degrees C and covered with a blanket from the neck down to keep them warm for 30 minutes.

The pain Visual Analog Scale (VAS) and the Fibromyalgia Impact Questionnaire (FIQ) was used to check the personal pain levels and outcome of the symptoms due to Fibromyalgia. After the first session of Waon therapy, all the women had important decreases in pain of 11-70% and after 10 sessions of the therapy, the effects settled at 20-78% of decreased pain. These significant decreases in pain and symptoms were determined using the pain Visual Analog Scale (VAS) and the Fibromyalgia Impact Questionnaire (FIQ), and these decreases were seen throughout the study period.

The researchers concluded that:

“Waon therapy is an effective treatment for Fibromyalgia Syndrome.”

Heat therapies in different forms are often used by those with fibromyalgia, with heated pool treatment being included in the EULAR evidence-based recommendations for managing Fibromyalgia. Heat was also rated as one of the most effective management therapies for Fibromyalgia by an internet survey of 2,596 people with Fibro last year.

References for this study:

Matsushita K, Masuda A, Tei C. Efficacy of Waon therapy for fibromyalgia. Intern Med. 2008;47(16):1473-6. Epub 2008 Aug 15.

Reference: Carville SF, Arendt-Nielsen S, Bliddal H, Blotman F, Branco JC, Buskila D, Da Silva JA, Danneskiold-Samsøe B, Dincer F, Henriksson C, Henriksson KG, Kosek E, Longley K, McCarthy GM, Perrot S, Puszczewicz M, Sarzi-Puttini P, Silman A, Späth M, Choy EH; EULAR. EULAR evidence-based recommendations for the management of fibromyalgia syndrome. Ann Rheum Dis. 2008 Apr;67(4):536-41. Epub 2007 Jul 20.

Bennett RM, Jones J, Turk DC, Russell IJ, Matallana L. An internet survey of 2,596 people with fibromyalgia. BMC Musculoskeletal Disord. 2007 Mar 9;8:27

Reference site: http://fibroaction.org

Medications

The anti-epileptic drug pregabalin is effective at improving pain and sleep in three different doses (300 mg, 450 mg, and 600 mg), and the drug is well tolerated by fibromyalgia patients.

A synthetic drug derived from marijuana may prove an effective addition to fibromyalgia treatment. In one study, nabilone (Cesamet), which is typically used to treat severe nausea and vomiting in chemotherapy patients, much relieved fibromyalgia pain compared to placebo.

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