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April 18, 2014

Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates

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Propofol Injectable Emulsion USP by Hospira Recall Visible Particulates

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FDA MedWatch Class I Recall 4 18 14

March 28, 2014

FDA Update on the Shortage of Normal Saline

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FDA Update on the Shortage of Normal Saline

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Voice Opposition to the 'Company Model'

Friday, February 15, 2013

The Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a solicitation for new potential safe harbors, modification to existing safe harbors, and special fraud alerts. The ASA is developing comments to submit to HHS-OIG and we urge ASA members to contact HHS-OIG and asking them to issue a special fraud alert regarding the “company model” and to make the modifications that the American Society of Anesthesiologists recommends to existing safe harbors to prevent referring physicians from profiting from their referrals. Under the company model, referring physicians, who typically also own the facility where surgical procedures are performed, form a separate anesthesia company in order to share in anesthesia revenue. ASA has serious concerns about the impact of the company model, and variations of that arrangement, on anesthesiologists, the patients they serve, and the integrity and fiscal soundness of Federal health care programs.


Please follow the below steps to submit a comment to HHS-OIG. Your comment must be submitted no later than 5 p.m. eastern standard time on February 26, 2013. This submission process will include completing a government online form with your first name, last name, and organization name. Using the copy and paste feature, you will be able to insert a message into the comments section as well as add any additional comments you feel are necessary.  We strongly encourage you to add comments, as the OIG is looking for detailed explanation of the justification for, or empirical data supporting, suggestions for a Special Fraud Alert or new or revised safe harbors. 


If you need any assistance with the comment submission process, please contact us at grassroots@asawash.org. Assistance with the process is also http://www.regulations.gov/#!contactUs.  


Please follow these below instructions step by step.

1. Click http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=OIG-121-N;fp=true;ns=true to guide you to the comment submission area for this rule (OIG-121-N) (be sure the label “OIG-121-N” appears on your comments).

2. In the left column, enter your first name in the noted space (Eg., John).

3. In the left column, enter your last name in the noted space (Eg. Doe)

4. In the left column, enter organization name as “American Society of Anesthesiologists” or your own practice's name.  (It would be best to list your own practice’s name, so the OIG appreciates that practices all over the county are affected by company model-type arrangements.)

5. With your mouse highlight this bold text below:


Re: Solicitation of New Safe Harbors and Special Fraud Alerts, OIG-121-N

As one of the over 50,000 members of the American Society of Anesthesiologists, I request that the Department of Health and Human Services Office of Inspector General (HHS-OIG) issue a special fraud alert regarding the “company model.” I have concerns about the impact these arrangements will have on anesthesiologists and the patients they serve. Under the company model, referring physicians, who typically also own the facility where surgical procedures are performed, form a separate anesthesia company in order to profit from their referrals by sharing in anesthesia professional fees. I am concerned that these types of arrangements could be fraudulent. Recently, HHS-OIG issued an Advisory Opinion (No. 12-06) on a "company model" arrangement and expressed the view that it could violate the federal anti-kickback statute.

Despite this guidance, company model arrangements and similar arrangements contInue to be used. I urge HHS-OIG to take the next logical step and issue a special fraud alert regarding these types of arrangements, and to make the modifications that the American Society of Anesthesiologists recommends to existing safe harbors to prevent referring physicians from profiting from their referrals.

6. Now copy the text above. (In windows, you may highlight the text and then click 'control c' to copy the text, you may select 'copy' from the appropriate toolbar, or you may right click the text after highlighting it and select 'copy'. On a Mac, you may highlight the text and then click 'command c' to copy the text or you may also highlight the text and then click 'edit' on the top of the screen and select 'copy' from the pull down menu).

7. In the right 'type comments' section on the website, click in 'comment box' until you see the cursor.

8. In the right 'type comments' section 'paste' the copied comments from above into the 'comments box'. (In windows, you will click 'control v', you may right click and then click paste or you may click edit and select paste from the pull-down menu. On a Mac, click 'command v' or click edit on the top of the screen and select paste from the pull down menu.

9. Verify that the material 'pasted' into the comments section on the webpage is the same as the material you copied above.

10. Please add any additional commentary that you feel is necessary or would assist the OIG to understand the problem that company model arrangements pose to Federal health care program patients. For example, discuss your own experience in losing business to a company model arrangement and the reasons why the referring physicians moved (or proposed to move) to that arrangement, focusing on such points as the following ones:


  • Adverse effect on the quality of health care services,
  • Adverse effect on patient freedom of choice among health care providers,
  • Adverse effect on competition among health care providers,
  • Adverse effect on the cost to Federal health care programs, and
  • The potential overutilization of anesthesia services.

11. Double-check the personal information you entered.

12. Click 'submit' located in the bottom right corner.

13. You will now be provided with a "comment tracking number." Please 'copy' and 'paste' the provided tracking number and email it to grassroots@asawash.org.


THANK YOU FOR YOUR ADVOCACY EFFORTS!

Review the HHS-OIG Notice.

Review the HHS-OIG Advisory Opinion.

Review ASA's formal communication to Inspector General Levinson dated February 27, 2012.

Review the updated Company Model FAQ.

Watch the Special Company Model Webinar Presentation.

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