FDA Warning on Vaginal Cosmetic Procedures

MEMO

To:                  Arkansas Mutual Policyholders: OB/GYN, Family Practitioners, Plastic Surgeons
From:              Rebecca Tutton, RN, JD, Risk and Patient Safety, Arkansas Mutual Insurance Company, Rebecca.tutton@arkansasmutual.com

Dear Policyholders:

I have provided a link to an FDA warning that came out June 30, 2018 regarding the use of energy-based devices to perform vaginal “rejuvenation” or vaginal cosmetic procedures, at the end of this memo.

An FDA August 2, 2018 update letter included some manufacturers that had been overlooked in the June 30 letter. I have included the link to this letter as well.

The warning states

“we alert patients and health care providers that the use of energy-based devices (commonly radiofrequency or laser) to perform vaginal rejuvenation, cosmetic vaginal procedures or non-surgical vaginal procedures to treat symptoms related to menopause, urinary incontinence, or sexual function may be associated with serious adverse events. The safety and effectiveness of energy-based devices for treatment of these conditions has not been established.”

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Arkansas malpractice law illegal, Griffen rules before trial

This story is from NWA Arkansas Democrat Gazette. Please click here for the original article.

January 9, 2018

By John Lynch

A Pulaski County circuit judge has declared as unconstitutional a law that shields Arkansas doctors accused of malpractice from being questioned at trial about whether their performance was adequate.

In a lawsuit against a Little Rock plastic surgeon scheduled for to begin January 9, 2018, Pulaski County Circuit Judge Wendell Griffen ruled that the law, a provision of the Arkansas Medical Malpractice Act, illegally bars patients who have sued their doctors from being able to ask the physicians about the “core” issue of their litigation.

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Invoicing Scam Targeting AR Physician Offices

WARNING!

EMV COMPLIANCE SCAM!!

EVM Compliance based out of Dallas has sent one of our clients a bill for $139.50 for credit card terminal download. THIS IS A SCAM.

EVM Claims to be a liability insurance for people who use chip type credit cards. They target physician offices hoping the office manager will pay the bill without checking to see if it’s legit.  IT IS NOT.

There are two claims with the Arkansas Attorney General’s office, one from a West Memphis physician and one from our client.

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HIPAA Training Requirements, Spring 2014 NL

HIPAA was enacted to safeguard patient security and privacy. The act includes 2 key pieces: The Privacy Rule and the Security Rule. The Privacy Rule helps protect private patient information and the Security Rule standardizes security protocols for electronic health information. Covered groups, including health care providers must adhere
to all provisions, including training requirements. The Office of Civil Rights (OCR) oversees and enforces all
activities.

Training of your workforce is a requirement. I have divided this into four (4) training groups:

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ICD-10 Launch Date: October 2015

UPDATE On April 1, 2014,  the Senate passed a House measure(HR 4302) that would delay a scheduled 24% cut to Medicare physician reimbursement rates AND push the ICD10 compliance deadline to October 1, 2015.  The bill now goes to President Obama who is expected to sign it before the scheduled cuts take effect on Tuesday, April 8, 2014.  The measure states,“The Secretary of Health and Human Service may not, prior to Oct. 1, 2015, adopt ICD-10 code sets as the standard for codes sets.”

 http://www.ihealthbeat.org/articles/2014/4/01/senate-passes-doc-fix-bill-with-one-year-icd-10-deadline-delay

 The transition will be required for everyone covered by HIPAA.  This change does not affect CPT coding for outpatient procedures and physician services.   Access the CMS.gov website for more information:

http://www.cms.gov/Medicare/Coding/ICD10/index.html?redirect=/icd10

Case: Medical Board Complaint by Mother

You are seeing an 18 year old in your office for a post-migraine evaluation.  She presents with her elderly grandfather and between the two of them gives you a history of past migraines.  The 18 year old is alert, oriented and appears responsible.  She had been to the ED the week before for a migraine that caused vision blurriness.  She was treated and released with follow-up with her PCP.  When she presents to you, her headache is dull with no other symptoms.  You perform a thorough examination, including an eye examination, look at her ED records and CT scan, look at her pediatric records and see she had been previously prescribed Imitrex.  She states she never had the prescription filled and only takes over-the-counter anti-inflammatories for her migraines.  Her mother and grandmother both have migraines but neither she nor the grandfather know what medications they took.  You provide her with an Imitrex prescription and offer her an injection for her headache.  She refuses saying she needs to work that evening and her headache is better.  You refer her to an ophthalmologist at her grandfather’s request.  She leaves and you believe she and her grandfather are satisfied with the care and treatment you have provided.

A week later, the patient’s mother calls and is very angry.  She alleges you didn’t do a physical examination and had you looked in her eyes, you would have known she did not have an ocular migraine.  The patient had been to the ophthalmologist and he told the patient she did not have ocular migraines.  The mother makes allegations that you told her daughter to take her mother’s migraine medications and shouldn’t be in practice.  You offer to see both the mother and daughter in your office.  She refuses.  She wants to transfer her daughter to your partner, and your partner accepts.  This is done.  The mother keeps calling and harassing the clinic staff and continues to make the same allegations.

You receive a letter from the Arkansas Medical Board about a complaint filed by the mother.  The Medical Board wants a response.  How did this happen?  What triggered this anger?  How do you prevent this from happening to you?  How do you respond?  Click here to read the article Complaints and Physician Behavior