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Text Version   RSS   Subscribe   Unsubscribe   Archive   Media Kit          August 22, 2014

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CMS' Open Payments System Re-Opens for Physician and Teaching Hospital Review & Dispute
AUGS
CMS has re-opened the Open Payments system after taking it offline to resolve a data integrity issue. Physicians and teaching hospitals may now resume registration, review and, as needed, dispute activities, and will have until September 8, 2014 to complete this process. This date accounts for all the days the system was offline to provide physicians and teaching hospitals with 45 days total to review and dispute their payment data. After the close of the 45-day period, industry will have an additional 15 days to resolve remaining disputes directly with the physician and teaching hospital and re-report any data that is changed.

The original timeframe was as follows:
  • Review and dispute (45 days): 7/14/2014 - 8/27/2014
  • Correction period (15 days): 8/28/2014 - 9/11/2014
  • Public website launch: 9/30/2014
The revised timeframe is as follows:
  • Review and dispute (45 days): 7/14/2014-8/2/2014 (20 days), 8/15/2014-9/8/2014 (25 days)
  • Correction period (15 days): 9/9/14 – 9/23/14
  • Public website launch: 9/30/2014
CMS took swift action to close the system and fully investigate issues which indicated possible data matching errors within the Open Payments system. Applicable manufacturers and group purchasing organizations (GPOs) submitted intermingled data, such as the wrong state license number or national provider identifier (NPI), for physicians with the same last and first names. This erroneously linked physician data in the Open Payments system. After careful review, CMS implemented a system modification that included more enhanced algorithms and validation checks to resolve the issues, and verified that the physician identifiers used by the applicable manufacturer or GPO are accurate, and that all payment records are attributed to a single physician. Incorrect payment transactions have been removed from the current review and dispute process and this data will not be published this year. Data accuracy is critical to the success of this transparency program, and CMS is committed to ensuring the integrity of data made available to the public.

Physicians and teaching hospitals can now register in Open Payments to review their payments: http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Physicians.html.
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NIDDK Funding Announcement
AUGS
The National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) is pleased to announce the release of a new funding announcement titled "Prevention of Lower Urinary Tract Symptoms in Women: Bladder Health Clinical Centers (PLUS-CCs) (U01)." The application due date is November 20, 2014. Please be advised that, although not required, a letter of intent is strongly encouraged to be received by KUH by October 20, 2014. The RFA is available at http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-14-004.html.

This Funding Opportunity Announcement (FOA) invites cooperative agreement research applications to establish a multi-center, multi-disciplinary consortium to be known as the Prevention of Lower Urinary tract Symptoms (PLUS) Research Consortium. This FOA expands NIH's research emphasis from treatment of women with established lower urinary tract symptoms (LUTS) to prevention of LUTS. At present there is insufficient information to undertake large-scale primary and secondary LUTS prevention efforts. The primary objective of this FOA is to plan, perform and analyze the research studies necessary to establish the scientific basis for future prevention intervention studies for lower urinary tract symptoms and conditions in women. The consortium will develop the evidence base for normal or healthy bladder function in females from adolescent girls to older non-institutionalized women to identify behavioral and other risk factors for conditions associated with LUTS with a particular focus on symptoms that are associated with the diagnosis of bladder infections, urinary incontinence, voiding dysfunction, overactive bladder and interstitial cystitis/bladder pain syndrome.

To request additional information, please contact Dr. Tamara Bavendam at tamara.bavendam@nih.gov.

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FPMRS ARTICLES


Effect of vaginal spheres and pelvic floor muscle training in women with urinary incontinence: A randomized, controlled trial
Neurourology and Urodynamics via Wiley
Multicentre parallel-group, open, randomized controlled trial. Women were allocated to either a pelvic floor muscle-training program consisting of Kegel exercises performed twice daily, five days/week at home, over 6 months with vaginal spheres, or to the same program without spheres. The primary endpoint was women's report of urinary incontinence at six months using the International Consultation on Incontinence Questionnaire-Short Form. Secondary outcome measures were the 1 hr pad-test, King's Health Questionnaire and a five-point Likert scale for subjective evaluation. Adherence was measured with the Morisky-Green test.
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Perineal outcome and the risk of pelvic floor dysfunction: A cohort study of primiparous women
Australian and New Zealand Journal of Obstetrics and Gynaecology via PubMed
Pelvic floor dysfunction is the most common complication of childbirth. Assumptions have been made that perineal trauma increases the risk of PFD compared to an intact perineum, however the evidence for this is lacking. The aim of this study was to explore the relationship between perineal outcome and postpartum PFD.
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Chronic pelvic floor dysfunction
Best Practice & Research: Clinical Obstetrics & Gynaecology
The successful treatment of women with vestibulodynia and its associated chronic pelvic floor dysfunctions requires interventions that address a broad field of possible pain contributors. Pelvic floor muscle hypertonicity was implicated in the mid-1990s as a trigger of major chronic vulvar pain. Painful bladder syndrome, irritable bowel syndrome, fibromyalgia, and temporomandibular jaw disorder are known common comorbidities that can cause a host of associated muscular, visceral, bony and fascial dysfunctions.
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Impact of transobturator tape treatment on overactive bladder symptoms, particularly nocturia, in patients with mixed urinary incontinence
Korean Journal of Urology
In this retrospective cohort study, the medical records of 237 women who underwent TOT surgery for the treatment of MUI were reviewed. Of these, 86 patients had preoperative nocturia. Patients with neurological diseases or sleep disorders that could affect the voiding pattern were excluded. Patients who were being treated with anticholinergics and antidiuretic hormones were also excluded, which left 70 subjects eligible for analysis. Pre- and postoperative evaluations consisted of a physical examination, 3-day frequency-volume chart, and health-related quality of life questionnaires.
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FPMRS NEWSBRIEFS


Nearly half of women in new survey reveal that their current treatments are not adequately addressing overactive bladder symptoms
PR Newswire via MarketWatch
Nearly half (46 percent) of women age 45 or older who experience symptoms of overactive bladder say their current treatment does not address their OAB symptoms, according to a recent survey conducted by The Harris Poll on behalf of Allergan, Inc. An estimated 39 million Americans are currently living with OAB, a common, sometimes disabling condition often associated with a considerable impact on patients with symptoms that include a strong, sudden need to urinate and urinary frequency with or without leakage.
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NIDDK Funding Announcement
AUGS
The National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) is pleased to announce the release of a new funding announcement titled "Prevention of Lower Urinary Tract Symptoms in Women: Bladder Health Clinical Centers (PLUS-CCs) (U01)." The application due date is November 20, 2014. Please be advised that, although not required, a letter of intent is strongly encouraged to be received by KUH by October 20, 2014.

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LUTS tend to improve after pelvic mass surgery
News-Medical.net
Surgical removal of a benign pelvic mass usually improves women's pre-existing lower urinary tract symptoms, study findings suggest. Kristina Cvach from Mercy Hospital for Women, Melbourne, Australia, and colleagues prospectively studied 29 women due to undergo surgery for a large pelvic mass — either a uterine fibroid or ovarian cyst measuring 7 cm or greater.

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P&G's new $7 billion category: Female incontinence
Cincinnati Enquirer
Procter & Gamble next week is getting back into the female incontinence market by launching its highly anticipated Always Discreet product in North America. Helping women with bladder control issues is not the sexiest business, but it could prove to be lucrative: The worldwide market is estimated to be $7 billion and growing quickly as populations in developed markets age.

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Post-partum pelvic floor exercises may have limited value
2 Minute Medicine
Pelvic organ prolapse is a common gynecological condition that affects many women. Women may experience vaginal pressure or bulging, stress urinary incontinence, and difficulty with urination and bowel movements, which can be distressing. Risk factors for POP include advancing age, obesity and parity. While the condition can be repaired surgically, many complications can be avoided through the use of other interventions.
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Endonovo Therapeutics developing non-invasive bioelectronic therapy for urinary incontinence
CNNMoney
Endonovo Therapeutics, Inc., a developer of non-invasive bioelectronic therapies, announced today that it has retained Holland & Knight, LLP as its legal counsel and Emergo Group, Inc. to assist the Company in obtaining FDA clearance of its non-invasive urinary incontinence treatment. Endonovo's bioelectronic platform, which is based on Time-Varying Electromagnetic Fields originally developed in conjunction with NASA, uses a proprietary waveform to stimulate tissue. TVEMF technology is fundamentally different from other magnetic pulse devices; it is based on the physics of electricity and magnetism as well as the physiology of cells and tissues.
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Colby Horton, Vice President of Publishing, 469.420.2601
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Caitlin McNeely, Senior Editor, 469.420.2692  
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