2012 Volume One Hundred-two

     
Greetings!

 

"Hot Topics" for 2012 continues to focus on information and news items of interest to the utilization review industry. 

 

This week, Hot Topics revisits sleep studies.  Sleep studies are frequently referred for utilization review.  Recent advances have made at-home sleep studies a real option for some patients.  Home studies are not appropriate for all patients, but can be a diagnostic tool for simple obstructive sleep apnea.  The PRC for sleep studies has been revised to reflect criteria for both in-center and in-home testing.

 

The clinical case today looks chemotherapy for HR2 positive breast cancer.  Oncology cases often involve review of appropriate versus investigational chemotherapy regimens.  The client in the case was concerned with whether the requested triple agent therapy was the standard of care.  

 

Our compliance section takes a look at a new law in New York that will be holding abortion clinics to a higher standard of care.

 

We hope that 2012 is a great year for you!

 

Linda  Sheff, MBA, Editor

Email Me    Linda Sheff 

 

 

  
In This Issue
Previous Hot Topics
Sleep Studies
Compliance Corner
PRN Case File
Care Management News

PRN Review Services   

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Hot Topics Archive

Today's Hot Topic: Sleep Studies and Polysomnography

Recent advances have made home sleep testing an option for some patients who are at risk for obstructive sleepYawn disorder (OSA).  There are considerable differences between what is being called the "overnight" and the "at-home" sleep studies.  An overnight sleep study is done in a sleep disorders center, with constant monitoring by trained professionals.  A home sleep test uses a portable-monitoring system that is consists of a small recording device, sensors, belts and related cables and accessories. The patient applies the sensors and turns on the recording device before going to sleep.
 
Diagnostically, an overnight study collects more data and may detect many types of sleep disorders in such as central sleep apnea, restless leg syndrome and parasomnias.   Sleep disorders centers accredited by the American Academy of Sleep Medicine record at least 12 channels of information and measures all aspects of sleep. This is known as "sleep architecture" and includes total sleep time, sleep efficiency, sleep stages and how long it takes to fall asleep. Measurements include airflow, breathing effort, blood oxygen, heart activity (electrocardiogram, ECG\EKG), brain waves (electroencephalogram, EEG), eye movements (electro-oculogram, EOG), chin movements (electromyogram, EMG), leg movements (EMG), snoring (Microphone), unusual behavior (video), and body position.  The term, polysomnography (PSG), refers to the continuous and simultaneous monitoring and recording of various physiological and pathophysiological parameters of sleep collected simultaneously for 6 or more hours with physician review, interpretation and report.  Overnight studies are most appropriate to help determine the causes of potentially life-threatening sleep disorders. PSG always includes sleep staging, while a cardiorespiratory "sleep study" does not.
 
Read more  on this topic for a discussion of its current status, indicators, contraindicators, references and insurance coverage by major carriers.

 

Compliance Corner: New York Enacts Stricter Regulations on Abortion Clinics

A new state law in New Yor was signed by Gov. Tom Corbett in late December and will take effect in June.

Under it, abortion clinics will be held to the same standards as free-standing ambulatory, or outpatient, surgical centers. 

 

The state's Department of Health will more clearly define the requirements.  Possible changes include HVAC system upgrades, an on-duty staff nurse to be present regardless of whether there are patients, bigger surgical rooms and wider hallways.  Legislators have said the changes were spurred by the investigation and subsequent closure of a West Philadelphia clinic where prosecutors allege illegal late-term abortions were carried out in filthy rooms with poorly trained staff.

 

Clinic owners have stated that some clinics may be forced to close due to the costs associated with the new regulations and have suggested that the New York legislature had that goal as part of their agenda.  However,  Rep. Stan Saylor stated that "This is not about pro-abortion or pro-life, it's about protecting people who go into these clinics." 

 

Read more on this story

PRN Case Files:    Combination Chemotherapy for HR2 Positive Breast Cancer

A 60-year-old patient is postmenopausal with a newly diagnosed stage IC (T1cn0) triple positive, specifically estrogen receptor positive, progesterone receptor positive and HER2 positive breast cancer.  The requested chemotherapy is a combination of Taxotere, Carboplatin, and Herceptin.

 

An article published in the New England Journal of Medicine described the BCRIG Study, which was a phase III study involving 3,222 women who were randomized to receive either doxorubicin, cyclophosphamide followed by docetaxel alone, doxorubicin, cyclophosphamide followed by docetaxel trastuzumab or trastuzumab, carboplatin and Herceptin.  The results demonstrated an improved disease free survival and overall survival for both trastuzumab containing arms, as compared to the non-trastuzumab containing arms for this group of 3,222 HER2 positive women.  The hazard ratios were virtually the same and the outcomes were virtually the same for both trastuzumab arms. 

 

However, what the study also showed was a decreased risk of cardiotoxicity in the patients who received the non-doxorubicin containing arm and it was similar to the patients who did not receive the trastuzumab arm.  Therefore, the outcomes were improved with the trastuzumab containing arm with either the docetaxel, carboplatin, or the doxorubicin cyclophosphamide followed by the docetaxel arm again with trastuzumab as compared to the non-trastuzumab containing arm with a decreased risk of cardiotoxicity in the non-anthracycline containing arm. 

 

 

This combination has been compendium listed in the National Comprehensive Cancer Network (NCCN) for several years as one of the standard recommended adjuvant chemotherapy regimens for HER2 positive patients with breast cancer.  There are no current ongoing clinical trials utilizing this regimen for the adjuvant therapy of breast cancer.  Review of clinical.trials.gov, finds that the combination of docetaxel/carboplatin/trastuzumab is the subject of a phase II clinical trial for the neoadjuvant therapy of breast cancer, not the adjuvant therapy of breast cancer, which is a different clinical setting and is also the active comparator, i.e. standard of care arm, for a phase III clinical trial.  Therefore, in this particular clinical setting, this therapy is not considered investigational/experimental by most plan guideline criteria.  The reviewing oncologist found the requested chemoptherapy to be appropriate for this patient. 

Care Management News

U.S. healthcare spending barely rose in 2010 from record-low recession levels, as high unemployment and the loss of private health insurance forced many Americans to delay or forego medical treatment, government officials said on Monday.  

 

Argentine President Cristina Fernandez never had cancer despite being diagnosed with the disease last month and having her thyroid gland removed on January 4, her spokesman said on Saturday.

  

Heart attack risk seen with Boehringer clot drug

Boehringer Ingelheim's Pradaxa blood clot preventer has been associated with a slightly higher risk of heart attack or acute coronary syndrome, according to results of a meta-analysis of several studies reported in a major medical journal.

  

Novartis issues recall on Excedrin, Bufferin
The U.S. unit of Novartis AG on Sunday issued a nationwide recall of certain bottled versions of Excedrin and Bufferin, and two other products, because they may contain stray, broken or chipped tablets from other Novartis products.

  

Click on the underlined title of each article above to see the complete report. 

  

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Albert G. Sheff, MDAlbert G. Sheff, M.D.
Founder - Physicians' Review Network, Inc.URAC Accredited Health UMURAC Accredited Workers Comp