Preventing Shingles

Shingles is a common disorder.  It’s caused by the reactivation of the chicken pox virus, varicella zoster virus, which remains dormant in one’s nerves after infection with chicken pox. Anyone who has had chicken pox is at risk.  Shingles is an unpleasant illness.  It causes prodromal nerve irritation, followed by the appearance of a blistering rash that follows the distribution of a nerve root. The rash can be painful and itchy, and can be the source of subsequent bacterial infection.  In some cases, cranial nerves, including nerves that supply the eye and ear, may be affected and this may lead to loss of vision or hearing.

The most unpleasant complication of shingles is the occurrence of “post-herpetic neuralgia,” defined as pain in the distribution of the shingles rash (or affected nerve root), which persists for more than three months after the shingles goes away--this may occur in 10 to 20% of cases.  Early treatment with antiviral therapy may reduce the risk of post-herpetic neuralgia.

One’s risk of developing shingles, and post-herpetic neuralgia as a complication, increases with age.  Immune deficiency, such as infection with HIV/AIDS or treatment with cancer chemotherapeutic drugs, also increases one’s susceptibility to shingles.  It is uncertain how the use of the chicken pox vaccine, now standard in children, will affect their adult risk of shingles compared with those who are unvaccinated.

A vaccine for shingles, Zostavax®, was FDA approved in 2006. In 2008 the CDC recommended that persons over the age of 60 receive the vaccine.  This recommendation is based on the relatively higher prevalence of shingles and its related complication in this age bracket. However, the shingles vaccine is also effective in healthy adults ages 50-59.  At this time the CDC has not recommended routine vaccination of this age group, which is likely related to lower disease incidence (about 4.6% annually in 50 year olds, compared with 7% annually in 60 years olds ,and 9 to 11% in 70 and 80 year olds).

Here are some common questions that patients ask me about the shingles vaccine:

1.       If I have already had shingles should I get a vaccine?

The shingles vaccine has not been tested in those who have already had shingles once. It is speculated that having the condition increases one’s immunity and helps prevent future recurrences. However, there is some research  indicating that those who have already been afflicted may continue to be at significant risk for recurrence. Therefore, it may be reasonable for this population to be vaccinated.

2.       What are the most common side effects related to the shingles vaccine?

According to the CDC, redness, pain, itching, and swelling at the site of the vaccine may occur in 1 out of 3 who receives the vaccine. Headache may occur in 1 out of 70.  More serious allergic reactions to the vaccine components including fever, difficulty breathing and throat swelling, are infrequent.

3.       Will it be safe for me to be around babies, pregnant women, and those with immune compromise after I have had the shingles vaccine? 

Yes, although it is a live attenuated virus vaccine, there have been no described cases of the chicken pox virus being transmitted in this manner from a person inoculated with Zostavax ®to a person who is not immune.

4.       In what population is the shingles vaccine contraindicated?

Although shingles is more common in those with immune compromise, the shingles vaccine is contraindicated in this population, which includes patients with HIV/AIDS, patients on cancer chemotherapy, patients on drugs that affect their immune system (such as oral steroids), and pregnant women. There are case reports describing disseminated shingles resulting from the vaccine in patients with established immune deficiency.

5.       I’m not sure if I had chicken pox, Should I have a shingles vaccine?

Persons who are unsure of whether or not they have had chicken pox should have blood work done to determine their immunity. If there is no evidence of previous exposure then a chicken pox vaccine (Varicella) should be administered in those who are eligible, not a Zostavax®.

6.       After 60, how often does one need a shingles vaccine?

Currently a single vaccine at or after age 60 is recommended.  The shingles vaccine is also FDA approved for patients ages 50-59 years.  However, given the lower disease prevalence and risk in this population the cost and health-benefit is not as well established and at this time the CDC does not specifically recommend it.  It remains uncertain how long the immunity conferred by a single shingles vaccine will last.

7.       What is the cost of a shingles vaccine?

A shingles vaccine costs approximately $200. Many health insurance plans, including Medicare Part D and private insurers, cover the immunization after (but not before) age 60.

For more information visit http://www.cdc.gov/shingles/index.html or http://nihseniorhealth.gov/shingles/aboutshingles/01.html .

 

 

 

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.