Dear Generic Drug Maker,

It is both annoying and possibly life-threatening that we no longer have adequate supplies of _______.  Please make more, thanks.

Signed,

“Anesthesia”

Not really sure how to deal with this problem (besides poking fun at it) we, at The Anesthesia Blog, have compiled a list of useful links.  The ASA is also taking a stand and getting behind the “Preserving Access to Life-Saving Medications Act” which would at least let give the FDA some lead time in dealing with an impending shortage.

Useful resources:

• ASA Drug Shortages
• FDA Drug Shortages
• American Health-System Pharmacists

Image: vongvanvi / FreeDigitalPhotos.net

Guest post by Mark F. Weiss, J.D., Advisory Law Group

Background: The “company model” is the name given to a type of suspect anesthesia joint venture likely violative of the federal antikickback law. In its simplest form, it involves the creation of a business structure by the surgeons controlling the flow of referrals to an ASC in order to profit from the provision of anesthesia services at the facility. Read my article The Company Model: Is Making Less Money To Work at a Surgicenter Worth Jail Time? appearing in the January 2011 issue of Anesthesiology News and available on the articles page at advisorylawgroup.com.

***

It’s one thing to make a profit from medical practice – in fact, I’m more than all for it.

It’s quite another to extort a kickback for the referral of patients. That’s a crime. In connection with Medicare and Medicaid patients it’s a violation of the federal antikickback statute (the “AKS”). In fact, simply offering or soliciting remuneration for referrals is a crime under that statute.

Over the past several years, the so-called “company model” of anesthesia services has taken form, through which ASC owner surgeons have extracted a share of fees from the anesthesiologists working at the facility.

Although this post is appearing on an anesthesia blog, you may want to remind your colleagues in other specialties that the company model is not simply an anesthesiologist’s issue. In a very real sense, anesthesiologists are the “canaries in the coal mine.” Little suspension of disbelief is required to see anesthesia company model thinking permeating into other areas, say, internists setting up entities to capture the profit of referrals to gastroenterologists.

Of course, all company model situations are rife with compliance concerns.

The AKS

The AKS prohibits remuneration, that is, the transfer of anything of value, for referrals. It also prohibits offering or soliciting that remuneration.

Certain exceptions, known as safe harbors, define permissible practices not subject to the antikickback statute because they are unlikely to result in fraud or abuse. The failure to fit within a safe harbor does not mean that an arrangement violates the law; there’s just no free pass.

Joint Ventures

HHS’s Office of Inspector General (the “OIG”) coordinates enforcement of the AKS.

The OIG uses the term “joint venture” to mean any arrangement, whether contractual or involving a new legal entity, between parties in a position to refer business and those providing items or services for which Medicare or Medicaid pays. Some joint ventures are legal – others are simply disguised violations of the AKS.

The OIG issued two important alerts on joint ventures, its 1989 Special Fraud Alert on Joint Venture Arrangements, republished in 1994, and a 2003 Special Advisory Bulletin on Contractual Joint Ventures, describing the features of suspect arrangements.

In essence, suspect ventures involve an owner in one line of health care business which expands into another related health care business line to serve the owner’s federal health care program patients. The expansion is accomplished by contracting with an existing provider of the second business line – that is, a potential competitor as to the second business line. The owner essentially arranges for the existing provider to run the new business line for the new venture, with the owner participating in the profits from what are essentially its own referrals.

Safe Harbors Are Not So Safe

Both the AKS and the OIG’s regulations set forth “safe harbors,” i.e., requirements, which if complied with, provide assurance that the payment practice will not be considered a violation of the AKS.

The OIG’s position is that good faith is required for protection within a safe harbor. Additionally, as the OIG made clear in the 2003 Special Advisory Bulletin, although a safe harbor may protect the payments in one direction, the discount given in the other direction may not be protected and therefore may trigger prosecution.

The Tighter the Economy the Stickier the Fingers

As the general, and the healthcare, economies become tighter, more individuals and entities in a position to generate referrals will consider the profitability of joint ventures. A subset will disregard the issue of legality.

For years, the American Society of Anesthesiologists has been urging the OIG to adopt a Special Fraud Alert on the company model situation. The ASA’s most recent letter to the OIG on this topic, dated February 2011, sites a survey in which 41% of the responding anesthesia practices indicated that they had been approached by ASCs to do company model deals, and that out of the total 332 requests to participate in a company model entity, the practices lost their contract to provide services at the requesting ASC in at least 159 instances. The OIG has yet to act.

However, in April 2011, the OIG issued an advisory opinion (Advisory Opinion 11-03) involving a proposed pharmacy company set up very similar to the average company model deal.

In the proposed facts disclosed to the OIG, a pharmacy providing products and services to long-term care facilities would form a new long-term care pharmacy to be owned in common with one or more long-term care facilities. The long term care facilities would, of course, now share in the profits of pharmacy services generated from their own facilities.

The OIG found the proposed arrangement likely violative, focusing on similarity between the proposed deal and the problematic arrangement outlined in the 2003 Special Advisory Bulletin, with the long-term care facility owners doing nothing to operate the new venture but receiving a share of the profits. Those facility owners would have little or no business risk and the payment to the new joint venture would vary with the volume or value of referrals from the facilities to the new business.

Even though, legally, the advisory opinion does not extend beyond that particular deal, it certainly does not bode well for potential requestors of opinions in respect of anesthesia company entities. Note, though, that a deal which is planned around the problematic elements of the Fraud Alert and the Special Advisory Bulletin may well receive the approval of the OIG.

Unfortunately, there’s no bright line test and the facts and circumstances of each situation must be fully analyzed to achieve an understanding of the potential risk. But in terms of potential penalties, fines, exclusion from Medicare and Medicaid, and even jail time, understanding the risk is worth substantially more than just a good night’s sleep.

___
© 2012 Mark F. Weiss

Mark F. Weiss is an attorney who specializes in the business and legal issues affecting anesthesiology and other physician groups. He holds an appointment as a clinical assistant professor of anesthesiology at USC’s Keck School of Medicine and practices with Advisory Law Group, a firm with offices in Los Angeles and Santa Barbara, Calif. He can be reached by email at markweiss@advisorylawgroup.com and by phone at 800-488-8014. His website, www.advisorylawgroup.com, features a plethora of complimentary resources. He’s happy to discuss this blog post with any reader.

Image: smokedsalmon / FreeDigitalPhotos.net

ASAPAC Remains America’s #1 Physician PAC
On January 31, the Federal Election Commission (FEC) released the filing results for calendar year 2011. According to these filings, the ASAPAC out-raised all other physician PACs, solidifying ASAPAC’s position as America’s largest physician PAC for the third year in a row. ASAPAC raised a total of $1.67 million in calendar year 2011, a new calendar year record for anesthesiologists’ political fund.

Jeff Mueller, M.D., Chair, ASAPAC Executive Board said Wednesday, “2011 continues to be a banner year for ASAPAC. The continued effective leadership of ASAPAC Representatives and members led ASAPAC to once again be the top physician health care PAC in America. As we start our 2012 effort; let’s make it another record year for America’s largest physician PAC and continue to raise anesthesiology’s voice during this formative election.”

Just to put this in perspective we scoured the Federal Election Committee website to find a frame of reference for our readers:

• American Association of Nurse Anesthetist’s CRNA-PAC raised $776,256
• American Medical Association’s AMA-PAC raised $943,715
• American Society of Plastic Surgeon’s PLASTY-PAC raised $144,658
• American Academy of Opthamology’s OPHTC-PAC raised $594,123
• National Association of Realtor’s PAC raised $4,001,698

Take from the above what you may.  Comments are open for this post.

Image: scottchan / FreeDigitalPhotos.net

Anesthesia Drugs Fast is an app for the iPhone, iTouch and iPad. It is designed as a point-of-care utility for calculating dosages for the most common anesthesia drugs. There is no Android version at this time.

Review:

One of the tenets of a well-designed app is simplicity and elegance. This is a single view app with only one control: the weight selection. Unlike other apps where you have to navigate through different screens to get information, everything is presented on one page.  Choose the patient’s weight from 1 to 200 kilograms, and this app will immediately give you a dosage range.

The drug categories are induction agents, muscle relaxants, sedatives, antiemetics and basic resuscitation medications. It gives you intravenous and intramuscular dosages for some of the medications. By touching the information button you can see the formulas used for the range calculation. With just one selection control and one page view, I found I could determine the proper dose while running down a hallway. It was that easy.

 Pros:

1. Probably the easiest to-use app I’ve seen.
2. Simple presentation, packed with the most common drugs on a single page.
3. Only one selection needed to get drug dosages

 Cons:

1. An Android version is lacking

Conclusion:

This is a well-designed app for the anesthesia provider. While those new to anesthesia will find it invaluable, seasoned clinicians will find it useful for pediatrics and bariatrics. It is so easy to use you can determine the correct dosage range while running down the hallway to a code.

Thanks to LK Louis for the info.

Abstract:

Objective
To study the association between exposure to procedures performed under general anesthesia before age 2 years and development of attention-deficit/hyperactivity disorder (ADHD).

Patients and Methods
Study patients included all children born between January 1, 1976, and December 31, 1982, in Rochester, MN, who remained in Rochester after age 5. Cases of ADHD diagnosed before age 19 years were identified by applying stringent research criteria. Cox proportional hazards regression assessed exposure to procedures requiring general anesthesia (none, 1, 2 or more) as a predictor of ADHD using a stratified analysis with strata based on a propensity score including comorbid health conditions.

Results
Among the 5357 children analyzed, 341 ADHD cases were identified (estimated cumulative incidence, 7.6%; 95% confidence interval [CI], 6.8%-8.4%). For children with no postnatal exposure to procedures requiring anesthesia before the age of 2 years, the cumulative incidence of ADHD at age 19 years was 7.3% (95% CI, 6.5%-8.1%). For single and 2 or more exposures, the estimates were 10.7% ( 95% CI, 6.8%-14.4%) and 17.9% ( 95% CI, 7.2%-27.4%), respectively. After adjusting for gestational age, sex, birth weight, and comorbid health conditions, exposure to multiple (hazard ratio, 1.95; 95% CI, 1.03-3.71), but not single (hazard ratio,1.18; 95% CI, 0.79-1.77), procedures requiring general anesthesia was associated with an increased risk for ADHD.

Conclusion
Children repeatedly exposed to procedures requiring general anesthesia before age 2 years are at increased risk for the later development of ADHD even after adjusting for comorbidities.

While time and smarter people than us will point out the flaws and confounding variables, it does seem like there is an emerging picture of neurotoxicity in repeat exposures to GA.

The popular press has a way of running with negative headlines when it comes to anesthesia.  Whether it is awareness under anesthesia, anesthesia providers gone bad, or weird side effects, the media is always ready to pounce.  This phenomena is most likely related to an underlying fear that the majority of their readers harbor and therefore buy more newspapers.  Our response, since the start of this blog, has been to cut through the BS and tell it like it is.  This mostly just succeeds in making ourselves feel better and not much else.  Some of the headlines related to this study:

Anesthesia before age 3 raises child’s ADHD risk
Children exposed to anesthesia multiple times are more likely to have disorder

-MSNBC

Could anesthesia cause ADHD in your child?

-FoxNews

General anesthesia in infancy linked to higher risk of ADHD

-CNN

Stay tuned for further developments.

Image: Salvatore Vuono / FreeDigitalPhotos.net

The advances keep a-happenin as they say.  It is a relatively new area of study one not amenable to randomized controlled trials in humans…hard to tell the IRB that the control group gets sugar water after a mega-dose of bupivicaine.   Therefore, most new data comes from our friends at the bench.  This months Anesthesiology further adds to our knowledge base on this topic.  Researchers in the U.K. analyzed the difference between mixed (medium- and long-chain) and long-chain lipid emulsions, for their ability to extract local anesthetic from serum.  They concluded that the type of emulsion may make the reversal more effective:

Lipofundin®, a lipid emulsion containing 50% each of medium-and long-chain triglycerides, sequestered all three drugs to a significantly greater extent than Intralipid® (long-chain triglycerides only) from human serum, which is in contrast with previous studies describing extraction from a buffer solution. These findings call into question the current advanced cardiac life support guidelines specifying use of a long-chain triglyceride emulsion for lipid rescue,²³ although further in vivo studies that confirm a significant improvement in resuscitation from local anesthetic toxicity with Lipofundin® are obviously required before drawing any confident conclusions.

In case you ended up here at this post in an emergency, or just want a refresher the protocol is as follows (from lipidrescue.org):

20% Intralipid:

1. Administer 1.5 mL/kg as an initial bolus; the bolus can be repeated 1- 2 times for persistent asystole.
2. Start an infusion at 0.25 mL/kg/min for 30-60 minutes; increase infusion rate up to 0.50 mL/kg/min for refractory hypotension.

or you can print it out here.  ASRA pdf version of protocol here.

Update 1/31/12.

Thanks to Dr Patel for bringing the “Lipid ALS” app to my attention.  We may get around to a full review but from the screenshots its seems worth the price:

Image: digitalart / FreeDigitalPhotos.net

The survey results are summarized (albeit a bit strangely) in this months Anesthesiology News:

Nearly half (49%) said they sometimes used the same vials of medication for more than one patient—a strict no-no for many kinds of drugs, including propofol.

But perfectly acceptable for many other drugs and this factoid doesn’t distinguish making it worthless imho.

(Indeed, 31% of clinicians who reported using propofol said they had used the same vial on multiple patients.)

When? Last week? In their lifetimes?  It is perfectly acceptable in many institutions for a pharmacist to aseptically split a large vial into smaller ones.  We did this during the great propofol shortage of 2010.

Roughly one-fourth said they did not always use a new needle and syringe when drawing medication from a vial

While technically bad from if it going to the same patient it is less of an issue.  Again, not delineated and the reader should hold there disgust until the facts are clear.

And about the same proportion reported using an open vial of medication even though they had not directly observed someone else opening the container.

Again not uncommon if it is timed, dated, signed and kept locked up this does not violate any rules I know of or the “treat everyone like your mother” doctrine I subscribe to.

Perhaps most concerning, the survey also found that four anesthesia residents in the state (8%) said they had reused syringes on different patients, although the researchers who conducted the survey expressed doubt that everyone who said they did so understood the question. Attending physicians were much less likely to admit to reusing syringes—2%, the survey found, which is in line with previous reports.

Ok what?  They didn’t understand the question?  Then what information should I be taking from this survey? Nothing? Ok.   Less likely to admit to?  Isn’t that journalist code for calling someone a liar?

This is serious business and we at The Anesthesia Blog hate to make light of it but the survey results, if they are true, are disturbing to say the least.  Seriously people if you can’t get your crap together I’m going to force y’all to watch this video on an endless loop:

Thoughts?  Are these results what you have observed in clinical practice?  Comment below.

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1) Electronic record accessible via touchscreen that shows a given patient’s entire medical history including every radiologic study they ever had and every encounter with any health care provider at any institution.

2) Voice recognition bed control so when the surgeons asks for the table up it happens without anesthesia intervention.

3) Wireless ASA monitors.

4) A reliable noninvasive way to monitor analgesia, CBC, lytes, Blood gases, cardiac output, cerebral/myocardial perfusion. etc etc.

It would be fairly reasonable to assume the many of these things won’t happen anytime soon.  Or will they?:

From Masimo press release:

Irvine, California – January 9, 2012 – Masimo today announced FDA 510(k) clearance and full market commercial launch of the Masimo Pronto-7®—a palm-sized handheld device designed for quick and easy noninvasive spot-checking of total hemoglobin (SpHb®), SpO2, pulse rate, and perfusion index.

This is not the first effort by our friends at Masimo to make most monitoring non-invasive.  Keep up the good work and I sincerely hope to see same papers testing the efficacy of this product in the OR.

Product info.