Andropause?

Everyone has heard of menopause, but is there a male equivalent? Two weeks ago at Personalized Primary Care Atlanta we discussed treatment of testosterone deficiency, or so called "andropause," in an evening health talk. PPC was happy to host Dr. Wayland Hsiao, Assistant Professor of Urology from Emory University as our discussant. Dr. Hsiao pointed out that declining testosterone levels are normal as men age and that while some men may be asymptomatic, others may suffer with symptoms that may negatively impact quality of life.

What are the symptoms of testosterone deficiency?  Loss of energy, decreased strength, reduced exercise capacity and erectile dysfunction are some. Testosterone deficiency may also contribute to metabolic syndrome, loss of lean muscle mass, and osteoporosis.  The ADAM questionnaire is a validated tool that can help identify symptomatic men.  Morley et al. Validation of a screening questionnaire for androgen deficiency in aging males. Metabolism. 2000;49(9):1239-1242.

Testosterone deficiency may be diagnosed on the basis of blood tests. Dr. Hsaio pointed out that saliva tests are not accurate.  Typically total testosterone and free testosterone levels are measured.  Free testosterone is the active version of the hormone.  If levels are low and men are deemed symptomatic treatment involves supplementation with testosterone, which is available in various delivery systems including transdermal gels, patches and pellets (implanted beneath the skin of the buttocks). Dr. Hsiao is of the opinion that injections of testosterone are not as well tolerated as the other delivery methods as they produce hormonal peaks and troughs that are associated with more adverse effects including flushes. 

Given the common nature of some of the described symptoms of testosterone deficiency it is not always clear who should be treated. One approach, for symptomatic men who have low or borderline testosterone levels, is a three month trial of treatment to see if symptoms improve.

What is the downside of testosterone replacement? One large clinical trial reported in the New England Journal of Medicine in 2010 demonstrated increased cardiovascular events in men who were randomized to treatment, and the trial was terminated early because of these adverse outcomes. However, Dr. Hsiao is skeptical that these risks translate to all men, and he noted that the population studied was primarily elderly, frail, and immobile.

Another concern with testosterone therapy is whether it has potential to promote prostate cancer growth in a man who may have subclinical prostate cancer or prostate cancer that has not yet been detected, and also whether it can cause enlargement of benign prostate tissue and contribute to worsening of urinary symptoms in men. Benign prostatic hypertrophy is another common condition that impacts quality of life in men as they age by causing reduced ability to urinate.  Dr. Xiao felt that evidence is lacking to suggest that either of these prostate conditions is affected much by testosterone therapy and sited data supporting this viewpoint.

It’s good to know that testosterone therapy exists as an option to help men with symptoms of andropause, which can adversely affect quality of life. However, those of us who have doctored through the era of the Women’s Health Initiative, which studied the effects of hormonal therapy for menopause, have to be somewhat cautious about prescribing treatment for a condition that affects a huge segment of the population. In the case of estrogen and progestin therapy in women, as discussed in a recent blog,  the pendulum has swung for, then against, and now recently partially back in favor of a cautionary approach to post-menopausal hormone replacement for symptom management during the time immediately following menopause in women.

To date testosterone therapy has been less well studied, and it could be years before the safety data for testosterone replacement in men is as good as the data for hormone replacement in women, which has been the subject of intense research in the previous decade.

Have Electronic Health Records Led to Fraudulent Upcoding by Physicians?

Over the past several decades medical costs in the United States have escalated rapidly, exceeding the pace of inflation and threatening bankrupt to Medicare.   As we heard in last week’s presidential debate, different solutions have been proposed on how to slow Medicare’s growth and reduce cost.  President Obama highlighted his administration’s success in tackling fraud and waste within the system. This strategy appears to be supported across party lines.  On face value it seems like a good idea, but what is not entirely clear to those of us within the medical community is how waste and fraud will be defined.  I have discussed this in a previous blog: "When is Unneeded Care Criminal?".

As reported by the New York Times last week,  recently attention has been focused on going after doctors and hospitals who some believe may be “upcoding” the complexity of their patient encounters to CMS and other insurers for the purpose of receiving better reiumbursement.  Apparently since the advent of electronic health records there has been a trend toward physicians' reporting higher complexity office visits.

The AMA (American Medical Association) Wire reports:

"The Centers for Medicare & Medicaid Services (CMS) notified the AMA that Connolly, a recovery auditor for what is commonly known as the Medicare RAC program, will begin auditing how physicians report CPT® code 99215, used to report evaluation and management (E/M) services. CMS appears to have also granted Connolly authority to extrapolate its review of sample claims to potentially recoup funds on 99215 claims it did not evaluate individually."

The AMA strongly objects to these audits and has written a letter to CMS pointing out that: 

"Audits of such complex services would result in erroneous payment recoupment and undue expense for physicians and CMS. According to the agency's own report to Congress, 46 percent of appealed Medicare RAC determinations are decided in favor of the physician or other health care professional."

What does upcoding mean? Medicare and other payers require that doctors use a convoluted coding system for billing medical visits based on their documented complexity. The system is so complex that for years it has outsmarted doctors who have been tasked with remembering the numerous elements required to justify the level of the visit (1 through 5), and then document the details required to support the billing level.

The selection of an appropriate billing code, as outlined in an 89-page guide prepared by CMS, if done correctly would without a doubt take the same amount of time (or perhaps more) as seeing the patient.  The end result:  most physicians, with limited time and partial recall of the complicated rules, pick the code that they feel best encompasses the visit level based on perceived complexity.

In the past when doctors dictated or hand wrote patient notes it was more difficult to include all of the historical factors required to support a higher level billing code. The use of electronic health records, however, has made the process easier by automating the incorporation of past medical history, medications, allergies, social history and family history into clinic notes, thereby allowing physicians to justify a higher level code. Until recently, based on personal experience, the tendency may have been to “under-code” complex visits, with fear that documentation would be inadequate to justify a more complicated billing code.  In reality, it is very time consuming to fully document the complex information that is exchanged in the context of a 15-30 minute office visit.
The purpose of medical documentation is to convey information.   Ideally doctors would be able to document the salient portions of each patient encounter that would help other providers care for the patient in the future.  In many ways electronic health records have helped facilitate medical documentation.  However, at the same time they have also led to the inclusions of extraneous information (for the purpose of supporting billing codes) that one is required to sift through while getting to the meat of the visit.
What is particularly enraging about these allegations of “upcoding” and fraud is that finally physicians have a tool to help ease the burden of Medicare’s inane billing code system—electronic health records; but now, after going through all the work and tremendous expense of transforming our practices and adopting these systems, we are threatened by the specter of accusations of fraud for “upcoding” the same visits that we’ve been “down-coding” for years.  If politicians would like to eliminate waste from Medicare why not simplify its billing system so that medical practices would not have to employ full time coding experts to ensure that their practices remain fiscally solvent? Of course, this would also eliminate a bunch of jobs.

 

Managing Menopause in 2012

Recently I hosted an evening discussion for Personalized Primary Care Atlanta members on the topic of menopause. Here is a summary of our discussion:

·         Menopause is defined by no menstrual cycle for one year.

·         The average age of menopause in the US is 51.

·         90% if American women experience menopause between ages 45 and 55.

·         Prior to menopause women go through a period of transition, often referred to as perimenopause. 

·         During this time of transition women may begin by having irregular menstrual cycles with changes in cycle length and periods of heavier or lighter flow. 

·         Later in transition women may skip one or more menstrual cycles and may begin to have symptoms related to menopause.

·         Irregular menses relate to anovulatory cycles and low levels of progesterone

·         For several years prior to menopause women may have higher than normal estradiol levels and lower than normal progesterone levels.  FSH levels may also be high.

·         Following menopause FSH levels are high and estrogen and progesterone levels are low, however menopause is not defined by hormonal levels, and because of individual differences in hormone levels and also normal fluctuations in levels throughout the cycle, hormone levels can be difficult to use as parameters of change.

Common symptoms of menopause are related to a decline in estrogen levels. For most women symptoms last several years.  However, in some, symptoms may continue for up to 10 years. About 10% of women in their sixties continue to have hot flashes.

Menopause Symptoms:

·         Hot flashes (last 2-4 minutes, affect the upper body and face, occur frequently at night)

·         Insomnia (may be a manifestation of temperature regulation trouble—hot flashes)

·         Heart Palpitations

·         Forgetfulness

·         Changes in sex drive

·         Irritability

·         Vaginal dryness

·         Trouble with control of urination

·         Changes in body composition—reduced muscle mass

Menopause Risks:

Menopause increases the risk of osteoporosis. Women lose bone density quickly during the first five years following menopause.  Menopause is also associated with an increased risk of cardiovascular disease. Women develop more insulin resistance, lower HDL levels and higher LDL cholesterol.

Managing Menopause Symptoms:

Approaches to managing menopausal symptoms include hormonal therapies, off -label use of non-hormonal therapies, and natural remedies.

Hormone Replacement Therapy

·         Hormone replacement therapy is no longer recommended for menopausal women for the purpose of prevention. 

·         Hormone replacement therapy has been extensively studied in the form of conjugated equine estrogen in a dose of 0.625 mg and medroxyprogesterone at a dose of 2.5 mg in postmenopausal women with an average age of 63 in the Women’s Health Initiative trial.  This trial involved approximately 161,000 women and reported on a number of outcomes.   The Estrogen and Progesterone arm of the trial was terminated in 2002 and found that women using the two hormones had a higher risk of blood clots, heart attacks, strokes, and breast cancer.  The same women had a lower risk of colon cancer and bone fracture.

·         Women in the Estrogen alone part of the study had higher risk of strokes and blood clots, but not breast cancer and heart attacks.

·         Three years following discontinuation of the study women treated with Estrogen and Progesterone continued to have a higher risk of cancer, including lung cancer. 

·         A subgroup analysis of the study found that most of the risk conferred by hormone replacement therapy was related to the age of the treated women. Women treated from the time of menopause forward for five years did not experience significant increases in health risk. 

·         For a sense of the magnitudes of health risk I recommend looking at the handbook

Changes in Practice a Decade Later

Hormone replacement remains the most effective treatment of menopausal symptoms. However, not all women require hormone replacement to get through menopause. Currently women’s health experts prefer to use the lowest dose of hormones available to control symptoms. Today, oral estrogen is available in one half the dosage that was studied in the Women’s Health Initiative study. There are several different types of estrogen and progesterone available on the market.  All estrogens appear to carry a similar risk of blood clot.  However, it remains uncertain whether different types of estrogens and progestins confer different health risks. In the case of progestins, they do seem to vary more in their activity and side effect profiles. The adverse effects of hormone replacement are speculated to relate to dose. Current practice has shifted toward the use of transdermal estrogen and progesterone through patches—also available in low dose. Transdermal estrogen confers a lower risk of deep venous thrombosis, and it is thought by some that to be safer with respect to other health outcomes.  Vaginal estrogen is an effective means to treat the urogenital symptoms of menopause—vaginal dryness and urinary symptoms, and does not require systemic progesterone to protect the uterus as do oral and transdermal estrogen.  It is felt that if use of hormone replacement is limited to the first five years following the time of natural menopause (around age 51), the cardiovascular risks may be lower. Tapering hormonal therapy slowly after several years may produce fewer symptoms than stopping cold turkey and can help facilitate the transition to menopause for some women.  Some women may choose to live with the health risks related to hormone replacement and may continue treatment for longer than five years—reporting improved quality of life.

What are “Bioidentical Hormones?”

Bioidentical hormones typically refers to custom compounds of hormones that are also manufactured and marketed as pharmaceuticals. However, bioidentical hormones are not tested and regulated. Given the range of hormone replacement now available on the market with numerous dosing options, many women’s health experts agree that it is safer to use products that have been more thoroughly investigated and that are regulated in the U.S. through the FDA.

Non-hormonal options for treating hot flashes are available as off-label use of prescription medications and include:

·         Selective Serotonin Reuptake Inhibitors and Selective Norepinephrine Reuptake Inhibitors: paroxetine (Paxil), venlafaxine (Effexor), bupropion (Wellbutrin), fluoxetine (Prozac)

·         Gabapentin (a seizure drug)

·         Clonidine (a blood pressure drug)

Natural Products

·         Plant Based Estrogens (Phytoestrogens) /Soy:  Not FDA regulated, might work in the body like a weak estrogen, might also have some health risk.

·         Black Cohosh : Also not regulated by FDA, lack of conclusive evidence that it helps, but has a fairly good safety record

 

For more information I also recommend the:

North American Menopause Society (NAMS) website and

the handbook:  Facts About Menopausal Hormone Therapy.

Or, contact me directly at drmavromatis@ppcatl.com