BOND PHARMACY, INCORPORATED, Doing Business as Advanced Infusion Solutions, Plaintiff,
v.
ANAZAOHEALTH CORPORATION, Defendant.
United States District Court, S.D. Mississippi, Jackson Division.
968*968 Walker W. Jones, III, David Wesley Mockbee, Jeffrey Scott Newton, W. Scott Welch, III, Baker, Donelson, Bearman, Caldwell & Berkowitz, PC, Jackson, MS, for Plaintiff.
969*969 John Adam Crawford, Jr., Butler, Snow, O'Mara, Stevens & Cannada, Jackson, MS, Charles E. Griffin, Butler, Snow, O'Mara, Stevens & Cannada, PLLC, Ridgeland, MS, Susan B. Morrison-Phy, Law Offices of Susan B. Morrison, Tampa, FL, for Defendant.
ORDER DENYING PRELIMINARY INJUNCTION
CARLTON W. REEVES, District Judge.
The above-styled cause is before the Court on the Plaintiff's motion for a preliminary injunction. After having considered the parties' pleadings, briefs, exhibits, testimony, and arguments, the Court finds that the motion should be and hereby is denied.
FACTS
Pursuant to Rule 52(a) of the Federal Rules of Civil Procedure, the Court makes the following findings of fact.
Advanced Infusion Solutions (hereinafter "AIS") and AnazaoHealth Corporation (hereinafter "Anazao") are competitors in the marketplace of compounded pharmaceuticals. AIS operates by creating customized mixtures of pain medication and selling them to patients, who ingest the formulas by use of surgically implanted, programmable pump devices (Durable Medical Equipment). Frequently, AIS serves customers who are insured by Medicare.
AIS and Anazao have different business models. When a physician orders acompound from Anazao, the company bills the doctor for its costs, after which the doctor awaits reimbursement from Medicare as he has represented to Medicare that the drugs are furnished "incident to" a physician service. See Exhibit A to Defendant's Response in Opposition [8-1] (Affidavit of Jacob Beckel).
Chuck Bell, the president and CEO of AIS, testified at the hearing on his company's motion that he believes AIS is not obligated to this process. When his company receives an order, AIS ships the compound to the patient's physician, and the doctor (or a member of her staff) injects the medicine into the patient's surgically implanted device. AIS then directly bills the insurance carrier, which relieves the physician from the obligations of paying for the product and waiting for reimbursement.
Anazao believes that this practice violates billing guidelines promulgated by the Centers for Medicare and Medicaid Services (hereinafter "CMS"). Anazao argues that CMS does not permit pharmacies to bill Medicare (or any private insurance carrier) directly for pain medication provided to physicians for administration to patients incident to the physicians' office procedures. According to Anazao, "CMS Medicare billing guidelines require that the physician `bundle' the cost of the medication in with the office visit charge and the pump calibration, fill and administration charges, and that only the physician and not the pharmacy could bill for practitioner administered medications." Defendant's Memorandum in Opposition [Docket No. 9] at 7 (emphasis included). AIS disputes this view of CMS guidelines. The dispute regarding these interpretations and the ensuing actions taken by the parties culminated in the filing of this action.
On January 18, 2011, Jacob Beckel, Anazao's chairman and CEO, distributed a letter concerning his company's position to current and former physician clients. Some of these physicians also use, or at least once used, AIS. The letter does not explicitly speak of AIS but refers to "a billing practice by at least one compounding970*970 pharmacy wherein the pharmacy bills Medicare directly on behalf of the physician, patient, or both." Exhibit F to Plaintiff's Reply Brief [Docket No. 12-6]. The letter avers that Anazao consulted with legal counsel, a Medicare billing expert, and various state Medicare offices regarding the legality of this billing model and was advised that the method runs afoul of CMS guidelines. See hearing Exhibit P-3.
According to Bell, although the January 18 letter does not mention AIS by name, his company began to suffer financial injury shortly thereafter.[1] Bell complains that the letter led a group of physicians to withdraw an invitation to an important conference and that he has received repeated phone calls from doctors expressing concerns regarding the letter's claims. Naturally, many of these physicians, according to Bell, have expressed great reluctance to do business with him or AIS for fear of being accused of Medicare fraud.
On January 31, 2011, AIS filed a Motion for Temporary Restraining Order, Preliminary Injunction and Other Relief [Docket No. 1], which it superseded on February 1, 2011, with a First Amended Motion for Temporary Restraining Order, Preliminary Injunction and Complaint for Other Relief [Docket No. 5] (herein after "the Complaint"). The prayer for relief seeks the following intervention:
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One could argue that Anazao is "fee-splitting" with the physician, so Anazao's claim thst AIS was violating Medicare's billing guidelines is a little like the pot calling the kettle black. Regardless, it is probably a good thing that a Summary Judgment was NOT granted, allowing the court to decide if Anazo unfairly competed with AIS's business.
ReplyDeleteWhat would be more interesting however, if CMS (Medicare) would issue a rule or declaratory statement saying, "This is the most appropriate way of billing for refilling an implantable pain pump with compounded drugs." Doing sonwould reduce fraud and abuse for all physicians and pharmacies, not just the parties in this case.
Kenneth Woliner, MD
www.holisticfamilymed.com
Physician's from out of state are going to AIS for their refills of !medicare Part B infusion medications. I am on a Medicare Advantage Plan and since AIS is out of state they are considered out-of-network and forcing the patients pay for the full cost of the Part B medication. If AIS is forced to follow CMS guidelines of billing the physician instead of the patient it would stop the physician to go back to in-network pharmacies. Since the medications are Substance II medications, the patients are not allowed to order or receive the infusion medications. I demanded my physician use a in-network pharmacy so I would not have to pay the cost of the infusion medications because the doctor knows he can order the medication from AIS and not be billed for the medication. What use to cost me nothing as it was part of my physician office visit, the cost to me is now over $6000/year. Most patients can't afford to pay this cost and will be forced to suffer in severe pain because they will have to have their pain pumps removed. This is nothing than a scam to benefit the physician and penalize the patients with high prescription costs.
ReplyDeleteAIS is billing my medicare advantage for services for in home infusion therapy. I receive NP in home treatment.the compounded drug is sent to my doctor who injects it into my implanted pump. They have billed over 9000.00 from 1/2019 through 4/2019.to my medicare plan
ReplyDeleteTo me this is fraud. When I was seeing another doctor for my pump,he did not use AIS,he used a different pharmacy and no problem like this. No one does anything about this when I submit a complaint
i am an RN Attorney, formerly worked within CMS (Medicare) as a clinical consultant in the fraud area reviewing complex cases that were under investigation by the US Attorney and OiIG - I guarantee you this situation is in no way ambiguous- what AIS is doing is absolutely in direct violation of MedicareRegulations! I am actually in disbelief they admitted they were doing what their competitor said -apparently in some kind of delusional state in even partially believing they aren’t doing anything wrong - I hope their arrogant and pompous you know what’s get nailed!
ReplyDeleteAnyway- I swear to anyone reading this, I am one of the top Medicare SME’s in the country and I know what I am talking about; there is not ONE scenario when a pharmacy, DME provider, infusion supplier, etc can directly bill medicare for drugs they supplied for administration in a physician office or clinic! (whether it’s a re-fill of an implanted infusion pump, or anything else - if it is incident to a physician service (and just the fact the medication is given there; even if the only person one sees is a nurse refilling a pump - that IS incident to -and the only entity on this planet that can directly bill Medicare for those drugs is the physician/physician practice!
However the true beauty of it all lies in the fact these absolute fools know what they are doing, they admitted in. court of law, under oath, to a judge no less - also have been advised it is in direct violation of Medicare regulations - yet continue the practices - when they eventually get caught (and they WILL get caught) thewe idiots have already satisfied the critical ‘knowingly & intentionally” component that takes Medicare waste and abuse over the line to fraud!
and Mr Bell - if you are reading this - not only should you be ashamed - you probably should start protecting your assets - becahuse at some point in the next 3 years the Feds will make sure you have nothing left when you complete the federal prison sentence youvwkill certainly serve...and deservedly so!
You are absolute garbage - a disgrace to your healthcare peers - i do not know how you can sleep at night...
...actually - maybe you shouldn’t... ever hear of a whistleblower “Chucky”???? Why don’t you just sleep on that...OK?