Federal & Multi-State Lawsuit Could Cost Healogics and Contracted Hospitals Millions

USA vs Healogics

From Jacksonville Business Journal: Claims against Jacksonville-based Healogics run deep and wide, with more than 600 clinics in 29 states named in federal fraud allegations brought by former employees of the wound care company.

The most recent lawsuit, which was filed in 2014 but unsealed in a Florida federal district court last week, details how two technicians employed by wound care centers operated by Healogics were pressured by the company to perform unnecessary procedures, procedures that were then billed to Medicare, Medicaid and Tricare, among others.

Jacksonville Business Journal Article

504 hospitals hit with whistle-blower lawsuit alleging false claims violations

READ THE FULL COMPLAINT

Medicare will require Prior Authorization of Non-Emergent (HBO) Therapy in 2015

-By Roque Wicker

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CMS has just announced that starting March 2015 three states (Illinois, Michigan, and New Jersey) will be required to get “Pre-authorizations” for the next three years for non-emergent hyperbaric treatments for the following indications:
1. Chronic refractory osteomyelitis
2. Diabetic lower extremity wounds (Wagner 3 and above).
3. Osteoradionecrosis.
4. Preparation and preservation of compromised skin grafts and flaps.
5. Soft tissue radionecrosis.
6. Actinomycrosis.
The decision was made due to “high incidences of improper payments for these services”.

Authorization times will vary from 10-20 business days and as little as 2 days for “imminent” treatment for a life or limb threatening indication.

According to the memo A provisional affirmative prior authorization decision, justified by the beneficiary’s condition, may affirm up to 36 treatments in a 12-month period.

To read more about this please click the links below:
Insurance news HBO article

CMS prior auth process

CMS prior auth (PA) HBO presntation

Say goodbye to nitrogen narcosis?

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Another discovery in the diving word eh?  Or perhaps an incentive for risk taking divers to go to the extremes – who knows.  It is fascinating to see that someone has created a “gummy bear for the deep”.

From SporkDiver.UK: Nitrogen narcosis, or the ‘Raptures of the Deep’, as Jacques-Yves Cousteau called it, is the disorientating effect and altered state of mind caused by breathing nitrogen at a high partial pressure. The deeper a diver descends, the higher the partial pressure of nitrogen and other gases in his air will be. For this reason, nitrogen narcosis is usually thought of as a function of depth. The deeper a diver goes, the greater the narcosis.

Read whole article here

Does your patient REALLY understand you?

HEAR YOU copyThis isn’t a language barrier question, this is a medical literacy question. Did you know that 9 out of 10 patients do not receive health information in a way they can use or understand?

 “Nothing, not age, income, employment status, educational level and race or ethnic group affects health status more than literacy skills”

Studies have shown that 40-80 percent of the medical information patients receive is forgotten immediately and nearly half of the information retained is incorrect. One of the easiest ways to close the gap of communication between clinician and patient is to employ the “teach-back” method, also known as the “show-me” method or “closing the loop.” Teach-back is a way to confirm that you have explained to the patient what they need to know in a manner that the patient understands. Patient understanding is confirmed when they explain it back to you. It can also help the clinic staff members identify explanations and communication strategies that are most commonly understood by patients.

Best Publishing has been kind enough to post a podcast interview about the teach back method as well as patient education.

Here is the link

The Relationship Between HBO Patient Education, Patient Satisfaction, Compliance, and Reimbursement

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Have you ever wondered why your patients quit hyperbaric therapy? Why would they quit despite the fact that they could potentially lose a toe or a foot? Sure a certain percentage of them are claustrophobic, some of them listened to their archaic physicians negative viewpoint of HBOT, some just do not care and have given up, then there are the ones we put in that “uncategorized box” because we really couldn’t pinpoint their rational, instead we categorize these patients simply as “NON-COMPLIANT”.

Are these patients really non-compliant or are they just uninformed and improperly educated? One should ask, “Who in the right mind would sacrifice losing a limb vs going in a chamber for two hours a day watching TV to save the limb in question?” Ask yourself the same question and if you are educated enough and informed enough (and not out of your mind) about the pros of HBOT and the cons of losing a limb, you surely wouldn’t opt for an amputation if you knew there was a possibility of saving that limb. So back to my original question, Why? Is there a possibility that the patient/s were not properly educated on how hyperbaric therapy works and the importance of “daily” treatments explained to them in a way they could understand? In this article I would like to describe the important relationship between improved and effective patient education, patient compliance, patient satisfaction, and value based reimbursement.

Read the whole article here: THE RELATIONSHIP OF PT EDUCATION ON HBO COMPLIANCE PT SATISFACTION AND REIMBURSEMENT

FDA Cracks down on “misleading claims” regarding Hyperbaric Oxygen Therapy

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The FDA is at it again.  If you have been advertising (even on your website) that you treat anything other than the “approved indications”  and you haven’t seen a “WARNING LETTER” from the FDA yet – IT WONT BE LONG before you do.  The age of regulation is upon us and the government needs to have a “return on investment” (ROI) for the hiring the largest number of regulators in US history.  Good, bad, or indifferent, everyone in the industry will be affected by this crackdown- even if you are doing everything correctly.  It will only take one bad news article about HBOT and down goes the reputation of the therapy.  I am sure you are asking yourself  “What does the FDA have to do with my advertising of my facility or my chambers?”  This is from the FDA’s website:

FDA’s Role

FDA encourages companies that offer DTC advertising to include accurate information in their ads. Through a comprehensive surveillance and enforcement program, the agency ensures that consumers are not misled or deceived by advertisements that violate the law.

In addition, FDA advances and encourages better communication of labeling and promotional information to health professionals and to consumers.

Please do remember that hyperbaric chambers are “cleared” by the FDA and that the FDA also monitors and can regulate the advertising of  “off-label” indications to the consumers.  I am sure one can argue that the FDA has no right to tell a physician what they can and cannot treat in their chambers but they do seem to have the right to monitor unsubstantiated claims about what HBO can and cannot treat.

In case no one has seen Title 21 (good reference).  I hope you enjoyed this update.

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TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H–MEDICAL DEVICES

PART 868 — ANESTHESIOLOGY DEVICES

Subpart F–Therapeutic Devices

Sec. 868.5470 Hyperbaric chamber.
(a)Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient’s tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (878.5650).(b)Classification. Class II (performance standards).

News articles:

FDA cracks down on misleading claims about autism therapies

FDA warns consumers about claims regarding autism treatments

 

FDA Notice/Warnings/Consumer Updates

Beware of False or Misleading Claims for Treating Autism