New Discoveries in Ovarian Cancer

in photo: Rebecca C. Arend, MD
(a GYN oncologist and ovarian cancer researcher at UAB)

The Laura Crandall Brown Foundation (LCBF), a local gynecologic (GYN) cancer foundation, encourages patients to be educated about their treatment options. LCBF’s CanSurvive Support Group meets monthly to help GYN cancer patients and their caregivers have a place to be around others on the same journey. At a recent meeting, Dr. Rebecca Arend, a GYN oncologist and ovarian cancer researcher at UAB, recently spoke with the group to share some of the results and information from her research on utilizing targeted agents to treat GYN cancers. Below is an excerpt from Dr. Arend’s presentation:

Since 2014, the FDA has approved 3 “targeted drugs” for ovarian cancer: Bevacizumab (an anti-angiogenesis agent) and 2 PARP inhibitors specifically for patients with BRCA germline mutations and tumors with somatic BRCA mutations.

“Additional research is being done and we are continuing to make new discoveries about the genes and pathways that suppress and promote cancer cell growth,” said Dr. Arend. Researchers are trying to identify therapies that can disrupt specific pathways and develop more targeted agents.

Improved and expanded genetic sequencing of tumors is enabling researchers to understand what is driving cancer metastasis and recurrence. In ovarian cancer, frequently the tumor suppressor gene TP53 is mutated and therefore, does not function as it should. In addition, about 15% of patients with ovarian cancer have a germline BRCA (or inherited) mutation. As tumors themselves have been genetically profiled, researchers have found that there are additional patients that have developed acquired BRCA mutations in the cancer cells specifically, even though the person does not have a germline mutation. Studies have shown that up to 50% of ovarian tumors have mutations in the same pathway as BRCA, called the Homologous Recombination Pathway and are thus considered to have Homologous Recombination Deficiency. Currently, PARP inhibitors are only approved for patients with germline and somatic BRCA mutations, but they could also be effective against other tumors with Homologous Recombination Deficiency. Trials are ongoing to investigate this.

UAB has started a Personalized Medicine Initiative (PMI) in the Gynecologic Oncology Division. Patients with recurrent ovarian cancer can consent to have their archival tumors undergo genetic sequencing and provide a blood sample to further investigate if tumor mutations can be detected in the blood. Since March of 2016, the Next Generation Sequencing Platform that has been used on the tumor is a 315 gene panel. The results are provided to the treating physician and are also added to the Ovarian Cancer PMI database. The patient’s physician then makes the clinical decision as to either recommend a targeted drug if one is available, a clinical trial, or a currently approved drug. The outcomes of the patients are being prospectively collected in order to provide additional information for current and future patients.

Enforcement Trends: Five Lessons from recent OCR Resolution Agreements and other enforcement risks

By: Beth Pittman, CHPC with Waller

Since January 2017, the Department of Health and Human Services Office of Civil Rights (OCR) has entered into two Resolution Agreements  for HIPAA violations, one Resolution Agreement for failure to timely report a breach, and one of only three Civil Money Penalties (CMP) imposed for HIPAA violations since 2009.  In 2016, OCR entered into 12 Resolution Agreements. That was at least double the number in prior years.

Lesson One:  If you are investigated by OCR for a HIPAA violation, be responsive.

Failure to timely respond to OCR notices may result in full imposition of CMP. Children’s Medical Center of Dallas was unable to reach a resolution with HHS and delayed requesting a hearing before an ALJ on the proposed CMP. The organization was required to pay the full of the CMP, or  appeal the CMP. Resolution Agreements are CMP and could not assert affirmative defenses, arguments for waiver or reduction substantially less than the full CMP which is based on a fine assessed for each day of the violation. For a violation classified as “reasonable cause” (as opposed to “willful”), the minimum fine is $1000 per day with a calendar year cap of $1,500,000. OCR does not limit violations to the breach, but typically finds additional violations; some stretching over several years. In settlement discussions, OCR considers the financial condition of the organization; an important mitigating factor for small or distressed facilities. This is not considered in assessing CMPs.

Lesson Two: Conduct a comprehensive security risk analysis and implement corrections.

Overwhelmingly, the top violation found by OCR was failure to complete an accurate and comprehensive enterprise wide security risk analysis (“SRA”), implement an enterprise wide security risk management process and corrections to identified risks and vulnerabilities. Absence of a SRA was a factor considered by OCR in proposing the settlement amount and corrective action plan reached in many Resolution Agreements. In the Resolution Agreement with Memorial Healthcare System, OCR noted violations that extended into the organized health care association (OHCA) when an affiliated physician group’s former employee login was used for over a year to access PHI to commit fraud. OCR recognized that the absence of a SRA, including all affiliated organizations within the OHCA, was a significant omission. Inadequate system audits and access controls would have been identified and could have prevented the breach. 

Lesson Four:  Encryption and device tracking.

More than half of the 2016-2017 Resolution Agreements addressed the failure to encrypt and then track mobile and portable devices on which ePHI is stored. If encryption is not implemented, then you must document the reason, and the alternative equivalent used. Monitoring movement of mobile and portable devices is a critical safeguard.  In each instance, the loss or theft of the device occurred because it was left in an insecure or unmonitored location. 

Lesson Five:  Business Associate identification and management is critical.

One of the largest settlements to date, $5.5 million reached with Advocate Health, was based in part on failure to have a business associate agreement with a billing company service provider. A covered entity, as well as its business associates, is liable for the HIPAA violation of the business associate. It is important not only to enter into business associate agreements but to also monitor and verify a business associate’s HIPAA compliance.   

Other Enforcement Risks:  False Claims Act and overpayment risks are associated with HITECH meaningful use attestation of HIPAA compliance.

Not only may failures in HIPAA compliance result in an investigation by the OCR, you may also be at risk in audits by the Department of Health and Human Services Office of Inspector General (OIG), False Claims Act actions or for Medicare Overpayments initiated by the government or whistleblowers. Payment of an incentive under the HITECH EHR Incentive program is conditioned on certification of compliance with specific HIPAA technical security requirements, including performing a security risk analysis. This may also be a material factor going forward in the amount of reimbursement paid by CMS. The OIG 2017 Work Plan specifically targets audits of EHR incentive recipients “to determine whether they adequately protect electronic health information.”  

Beth Pittman serves as Counsel to the Waller Health Law practice in the Birmingham office.

It’s a Bird, It’s a Plane…… Nope, Just a Man on Testosterone

By: Dr. Brian Christine

You see it on television. You hear it on the radio. You read about it in men’s and sports magazines. I’m talking about men and hypogonadism or, as it’s more commonly referred to, “Low T.” There is no shortage of popular media concerning hypogonadism in men. Unfortunately, the information available to our patients is often incomplete or downright incorrect. Let’s look at the issue of low testosterone in the male population.

Testosterone is produced by the Leydig cells in the testes. Stimulated by luteinizing hormone (LH), the Leydig cells secrete testosterone, and that mechanism has profound effects upon men. Under the influence of testosterone, an embryo will become male. Because of testosterone, men generally have greater muscle mass, a deeper voice, and more body hair than women. Testosterone is also directly linked to a man’s libido, his desire for sexual activity.

Testosterone levels are highest during adolescence and early adulthood. After a man’s 20’s, his levels fall each year. As a man’s testosterone levels fall, he experiences progressive difficulty maintaining lean muscle mass, he may have less energy, and his libido decreases. Small wonder that pharma has seen a huge opportunity to market testosterone replacement products to a progressively aging population, and small wonder that men who see and hear commercials pushing treatment for “low T” as a panacea to restore desire, muscle, vigor, and youth flock to doctors expecting miracles. However, it’s not simply a matter of giving every guy who shows up at your office testosterone. There is a right way, and there is a wrong way.

At Urology Centers of Alabama, we have realized that many patients are not adequately educated about the potential benefits of testosterone, the risks of testosterone replacement therapy, and have not been given realistic expectations. In an effort to improve our screening of men who seek testosterone therapy and our management of men with true hypogonadism, we have established our Men’s Hormone Replacement Clinic. This clinic, focused exclusively on our male patients who are experiencing suboptimal serum testosterone levels, is managed on a day-to-day basis by Nurse Practitioner Eric Westerlund and supervised by me, Dr. Brian Christine.

We perform a complete history, pertinent physical exam, and obtain a detailed laboratory evaluation based on recommendations from the Sexual Medicine Society of North America and the American Urologic Association. We discuss a spectrum of treatment options, including oral clomiphene, topical testosterone gels, intramuscular testosterone injections, and subcutaneous testosterone pellet insertion, and we absolutely discuss potential complications. In the Men’s Hormone Replacement Clinic, periodic monitoring is required every 6 months. Perhaps most importantly, we tell men what testosterone cannot do: testosterone is not a time machine; it cannot turn back the clock and make a 50-year-old feel like a 20-year-old; it cannot magically turn fat to muscle, and it will not make a man with erectile dysfunction potent again.

Testosterone can truly help men feel and perform their best at their age. Careful evaluation and management are a must. Setting expectations is vital. Within these provisos, testosterone replacement therapy is a worthwhile undertaking and one that we as physicians are increasingly asked to perform. No, we cannot produce supermen, but we can benefit our male patients.


To learn more visit www.urologycentersalabama.com


Brian S. Christine, MD
Director of Erectile Restoration and Prosthetic Urology, Urology Centers of Alabama
Director of the Urology Centers of Alabama Fellowship in Prosthetic Urology and Men’s Sexual Health
Member of:
The Sexual Medicine Society of North America
The Society of Prosthetic Urologic Surgeons
The International Continence Society
The European Association of Urology

Why Real Estate?

By: Jerry L. Kitchens, Jr. M.D., PC.

I have been asked many times recently, “Why did you get your real estate license and what are you doing with it?” That’s a great question with a complicated answer. The simple response would be, “Well, a surgeon who no longer operates needs something to do”. But to be honest, it was an evolution.

I first met my broker years ago when I was president of a six-man group looking for an office in Homewood. Rich Campbell was honest and very helpful as we worked through the options. In the end, we did not buy the building he showed us but our relationship continued.

 Over time, he started Veritas Medical Real Estate Advisors to represent physicians as they tried to navigate the confusing world of office space and buildings. Fortunately, he asked me to consult with him during the formative days. I will be the first to admit that the hectic schedule of a surgeon left little time to truly help him. He was polite enough, however, to indulge me. As time went by, I got more involved and realized how much I liked it. After my days in the OR were done, I decided to get my license and help Rich as much as I could to engage and assist physicians in negotiating leases and/or purchases. While I am still a “new boy”, I have an excellent teacher.

 I think I should mention that this isn’t the only hat I wear. I work part time in administration at St Vincent's Health System and run a spice business on the side. I’m involved with a physician owned med mal company and do some things with my dad, as well as try to keep up with my wife and 5 kids. So, I am not at Veritas every day, but I must admit they make me feel at home anyway and the satisfaction of a job well done for former colleagues is worth the trip. Come see us!

jkitchens@veritasmre.com

rich@veritasmre.com

It’s all about Timing with Dyrc Sibrans, M.D.

By: Lori M. Quiller, APR
Director of Communications and Social Media Medical Association of the State of Alabama


Dyrc Sibrans, M.D., still greets patients with a firm handshake and a friendly smile. His laughter is infectious and easily fills the room as he reminisces about what he’s accomplished during his career. Already retired once from his own thriving medical practice in Decatur in 2000, he originally prepared to spend more time with his wife at a fishing cabin they purchased in Montana, but something just wasn’t quite right. It was all about timing.

“The personal relationships you build with your patients is what’s so special to me,” Dr. Sibrans said. “I thought that it was probably time for me to get out. We bought the place in Montana in 1998, and went out there after I retired in 2001. I had a stack of books on one side of my chair that kept me in that chair until I had read them all and moved them from that side of the chair to the other side! I never had time before to read just for fun until I retired.”

The allure of Big Sky country was more than just reading for Dr. Sibrans. He’s an avid fly fisherman, and with miles and miles of streams awaiting him, the Alabama rheumatologist actually felt right at home…for a little while. But, as with most who answer a calling in their lives, the first retirement never quite sticks. So, when he was asked to review a few charts for a small community free clinic back home, he happily obliged. It wasn’t long before those few chart reviews became to mean much more to him and to the Community Free Clinic of Decatur-Morgan County. Today, Dr. Sibrans serves as the clinic’s medical director.

The Community Free Clinic of Decatur-Morgan County opened in 2004 and provides free medical care, dental care and prescription medication for low-income residents of Morgan County. Staffed by a handful of full-time employees, the medical staff are all volunteers and has expanded to care for more than 3,000 patients annually.

“I did some chart reviews here when the clinic first started, and they needed a physician to help review the charts that the nurse practitioners had done during the day. We had about three or four of us doing that in the beginning. We average about 20 patients a night, and we do clinic two days a week. That’s a lot. Occasionally we have about three or four doctors that will come in after they have closed their practice, and we’ll finish up the night together. We get here about 4 p.m., and we go until we get finished, but we aren’t the ones who have the long days. The ladies in the office have the long days. They stay a lot longer than we do because they have to do all the paperwork,” Dr. Sibrans explained. The difficult part is to continue to recruit physicians willing to volunteer. The clinic does not take walk-in patients, and there is a screening process. Patients are seen at times when most working physicians have just closed their practices for the day, this makes it difficult for some physicians to come to the Clinic and work three additional hours.

“I do interviews mainly to get some more doctors to come in and volunteer. I think it is a privilege as medical professionals to volunteer. I think it is our responsibility to the community to, in some way, give back to the people who gave so much to us,” Dr. Sibrans said. “When the clinic first opened, they had a lot of physicians who would come in and volunteer. But, over the years, they began to drift away and things got worse. I was doing the chart reviews and noticed there were just a few people doing a lot of the work. Pretty soon I was asked to be fully on board.”

Early on in Dr. Sibrans’ career, he made a critical choice about his career…a choice which could have landed him far outside the path of medicine.

“I have some questions about some of the things I have done in my life, but becoming a physician is definitely not one of them. I truly enjoy it. I knew when I was in high school that I was either going to be a priest or a doctor. I went to the seminary and realized that maybe the celibate life maybe wasn’t the life for me!” Dr. Sibrans laughed. “So, I answered a different calling, and I do consider medicine my true vocation. I had already made up my mind that medicine was what I was going to do. I was a late bloomer. I didn’t really get going in academics until my senior year in high school. Most kids now have to start making great grades in high school. I was very lucky. I got into medicine long before the control by the federal government and insurance companies. The demands that you have to be automated now, it just takes too much time to do what you need to do, and that’s to simply treat your patient. The practice of medicine has become way too difficult these days.”

As a battalion surgeon with the 173rd Airborne Brigade, Dr. Sibrans was part of the Battle of Dak To at the beginning of the Tet Offensive, a nasty battle lasting 19 days and killing 376 U.S. soldiers. He was wounded himself during this battle. Even though he spent much of his time mending his fellow soldiers after battle, Dr. Sibrans found time to render aid to a Montagnard hospital in the highlands not far from his camp.

“Later, we were at a relatively benign base doing protection services. At that time, I was just doing sick call that could mostly be taken care of with antibiotics or cough syrup. I asked for permission to go to that hospital to help out. They were operating on anyone who came in. I saw stuff there that I hadn’t seen since Tropical Medicine in medical school. It was fascinating! All sorts of stuff that I had only read about and never seen again. One day a leper came in, and he was sent on to the leper colony a few miles away that was run by French nuns. I’d never seen anything like that, so I went to volunteer any way I could. I only went twice. Apparently some Viet Cong came into the colony looking for someone. I don’t think they were looking for me. I think they were looking for a Montagnard chief, but our intelligence people found out, and I couldn’t go back. I contacted my wife stateside who got in touch with some drug companies who donated some medicine back to the colony several times. That was such an eye-opening experience. I don’t know that I did that much good, but I know I learned a lot. I tell you what, the training I had at the University of Alabama, and the time I spent at the ER and in the VA, I felt like there wasn’t much I couldn’t handle for at least a little while,” Dr. Sibrans said.

With a lifetime of medicine and volunteerism under his belt, Dr. Sibrans is getting ready to retire…again…at the end of the year. There will be more time for family, reading, fly fishing and his many other hobbies, but when he talks about retiring there’s a bit of a twinkle in his eye.

“It took me a long time to decide to retire. It’s like an old saying I heard a long time ago in medical school that if you’re thinking about doing a tracheostomy, then you should have already done it. So, if I was thinking about retiring, I probably should have already retired!” Dr. Sibrans laughed.

For more information about the Community Free Clinic of Decatur-Morgan County or to become a volunteer, please contact Executive Director Jessica Payne at (256) 309-2491.

Sleep: A Preventative Measure

By: Amita Chhabra M.D
Brookwood Baptist Health, Primary Care - Hoover

At one point or another, everyone has had a two cup coffee day. What makes you reach for that second cup? Perhaps it’s the belief that the extra caffeine may jolt us into having a more productive and efficient day. That may just be a tale some live by. However for most, night time has become a cycle of sleep deprivation and poor sleep patterns. Unfortunately, there is no amount of caffeine that will be able to compensate. In the outpatient setting, we see patients that would like to address complaints of fatigue, anxiety, obesity, hypertension and the list goes on in our every day practice. Oftentimes we preform extensive workups of thyroid, mood, and other organic causes to explain causes of ongoing fatigue. We could avoid testing by asking a simple question: How is your sleep?

The CDC recommends adults get between seven to eight hours of continuous sleep. In some cases, that is just not possible. If you’re anything like me, I’m happy to have four continuous hours of sleep after the birth of our daughter. However, there are some glorious nights when a full night’s sleep changes your entire day. It has been studied 40% of adults report falling asleep during the day, without realizing it, at least once a month. This is called microsleep. It typically occurs when a person will momentarily fall asleep in a conversation, while listening to a lecture, or even while driving. Microsleep is different than narcolepsy. It is typically characterized by not understanding an explanation, or having to repeat phrases, or even “zoning out” while driving. A person who does not have restorative sleep falls victim to a continuous sleep deprivation. They can experience these episodes of microsleep without carrying the diagnosis of narcolepsy. The same person, that experiences an episode of microsleep, may not have those symptoms the next day after a full night’s rest.

Poor sleep is linked to many chronic health conditions. Patients can be evaluated by asking a few simple questions to aide in their overall health. What time do you go to bed? Do you wake up feeling refreshed? How many times is your sleep interrupted during the night? Have you been told that you snore? These key questions that can lead to the diagnosis of sleep deprivation or sleep deficiency without invasive testing.

 If patients aren’t getting the required amount of sleep, providers should introduce recommendations regarding sleep hygiene. Put simply, sleep hygiene prepares the brain for sleep. Sleep hygiene consists of having a routine at bedtime that should be consistent on the weekday and weekends. Avoid screen time, strenuous exercise, and heavy meals at least one hour before bed. It’s important to note that alcohol, nicotine, and caffeine are stimulants that work against the winding down of the brain and body. These kinds of stimulants should be strictly avoided before bed. It is no secret that cardiovascular disease, diabetes, obesity, and depression can all be exacerbated when sleep is compromised. A sufficient amount of sleep may just be a preventative measure for many patients.

Are you sleepy?

By: Stuart J. Padove, M.D. with Medical West Sleep Medicine

Are you sleepy? We would like to introduce you to our Sleep Center here at Medical West!

Have you ever said?:

• I have been told that I snore

• I suddenly wake up gasping for air during the night

• I have been told that I stop breathing while sleeping

• I feel tired during the day even though I slept all night

• I have high blood pressure

• I’m tired during the day no matter how much sleep I get

• I have leg pains at night

• I kick my legs during the night

What do we treat? There are about 88 kinds of sleep disorders, but typically we most commonly see individuals with symptoms of:

• insomnia

• sleep apnea

• narcolepsy

• restless legs syndrome and/or periodic limb movements.

About one-third of the population has some form of insomnia at any given time, and 10% of that group has chronic insomnia. According to the National Sleep Foundation, a large majority (75%) of Americans say they've had at least one symptom of a sleep problem a few nights a week or more within the past year.

If your doctor suggests you undergo a sleep study, or polysomnography, you may be wondering what is involved in this test and what to expect. First, a sleep specialist will meet with you to discuss and review your symptoms. If a sleep study is determined to be needed it will then be scheduled. Sleep studies help doctors diagnose sleep disorders such as sleep apnea, periodic limb movement disorder, narcolepsy, restless legs syndrome, insomnia, and nighttime behaviors like sleepwalking and REM sleep behavior disorder.

A sleep study is a non-invasive, overnight exam that allows doctors to monitor you while you sleep to see what's happening in your brain and body. For this test, you will go to a sleep lab that is set up for overnight stays—usually in a hospital or sleep center. While you sleep, an EEG monitors your sleep stages and the cycles of REM and nonREM or NREM sleep you go through during the night, to identify possible disruptions in the pattern of your sleep.

A sleep study will also measure things such as eye movements, oxygen levels in your blood (through a sensor—there are no needles involved), heart and breathing rates, snoring, and body movements. A sleep study is done in a room that is made to be comfortable and dark for sleeping. You'll be asked to arrive roughly two hours before bedtime. You can bring personal items related to sleep, and you can sleep in your own pajamas. Before you go to bed in the exam room, a technologist will place sensors, or electrodes, on your head and body, but you'll still have plenty of room to move and get comfortable.

If you have symptoms of a sleep disorder, such as the ones above, we are here to help! For more information, please see our website at: http://www.medicalwesthospital.org/sleep-center.php