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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Navigating Section 1557, Effective 10/16/16

Please click here for our checklist, frequently asked questions, and resource list to navigate Section 1557.

As part of the Affordable Care Act the Department of Health and Human Services published a final rule to implement Section 1557 which prohibits discrimination in health coverage and care based on race, color, national origin, age, disability and sex. Covered Entities must take reasonable steps to provide meaningful access to each individual with Limited English proficiency who is eligible to be served or likely to be encountered in their practice.

Covered Entities must provide free, accurate and timely language assistance service and protect the privacy and independence of an individual with limited English proficiency. This is obtained by offering a qualified interpreter when reasonable for oral communication and use a qualified translator to communicate directly with individuals.  The Covered Entity may not rely on bilingual/multilingual staff unless they are a qualified interpreter nor can the Covered Entity require an individual to provide his or her own interpreter.

 

New HIPAA Privacy Rule

Beginning February 5, 2017 a new HIPAA Privacy Rule allowing certain Covered Entities the ability to disclose to the FBI’s National Instant Criminal Background Check System (NICS) will become effective.

The identities of those individuals who, for specific mental health reasons, may be reported who are already prohibited by Federal law from having a firearm.  While this provision enables the reporting of the identities of these individuals to the background check system, their individual privacy interests are protected.

Rebecca Tutton, R.N., J.D.

Click here to view Reporting Mental Illness

 

ICD-10 Launch for October 1, 2015

Only 5 months to go until the launch of ICD-10!  There is nothing to indicate the federal government will again delay this implementation.  ICD-10 (diagnostic codes) does not affect CPT (procedural) coding for outpatient procedures and physician services.

Here are some of the changes in regard to the diagnosis codes in ICD-10:

  • ICD-10 has gone from 17 chapters to 21 chapters.  In ICD-9, there were V-codes and E-codes that were not classified as “chapters.”  That accounts for 2 of the 4 new chapters.  The other 2 are the result of diseases of the eye and ear each being promoted out of the nervous system chapter.  There are also some codes that have been reclassified into more appropriate categories based on current medical knowledge.

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HIPAA Violations Can Have Consequences: WellPoint pays HHS $1.7 million for leaving information accessible over Internet

Original article posted by HHS July 11, 2013

The managed care company WellPoint Inc. has agreed to pay the U.S. Department of Health and Human Services (HHS) $1.7 million to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules.

This case sends an important message to HIPAA-covered entities to take caution when implementing changes to their information systems, especially when those changes involve updates to Web-based applications or portals that are used to provide access to consumers’ health data using the Internet.

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New HIPAA Education Video: HIPAA Basics & Beyond

The goal of this video is to present the HIPAA basics and beyond the basics to assist in the HIPAA educational requirement. The presenter is Rebecca Tutton, J.D., R.N., Director of Risk Management at Arkansas Mutual Insurance Company. Following the video, a simple post-test is located on this page for completion. Upon completion, turn the post-test in to your privacy officer and it will become part of your HIPAA educational program for your employees and associates.

Click for the Video: http://www.arkansasmutual.com/risk/videos/hipaa/basics-beyond-practice/

 

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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