Forest Rehabilitation Medicine PC v Geico Ins. Co. (2013 NY Slip Op 50340(U))

Civil Court of the City of New York, Richmond County

6352/11

Law Office of Jennifer M. Cassandra (plaintiff)

24 Shepard Avenue

Staten Island, NY 10314

Law Office of Teresa M. Spina (defendant)

170 Froehlich Farm Boulevard

Woodbury, NY 11747

Philip S. Straniere, J.

Do something special

Anything special

And you’ll get better because

You gotta get gimmick

If you want to get applause.^[FN1]

[*2]Plaintiff, Forest Rehabilitation Medicine PC (Forest) assignee of John Russo (Russo), commenced this action against the defendant, GEICO Insurance Company (GEICO), alleging that the defendant failed to pay for first party medical benefit services rendered to Russo as required by the New York State No-Fault Insurance Law [Article 51 New York State Insurance Law]. A trial was held on January 29, 2013. Both sides were represented by counsel.

The parties stipulated that the plaintiff had timely submitted the billings in question and that the defendant had timely denied payment based on “lack of medical necessity.” The services in question are high frequency pulsed electromagnetic stimulation treatments performed by plaintiff using a TMR 1200 machine manufactured by Scientific Imaginetics. TMR stands for “therapeutic magnetic resonance” and is a method of providing high frequency electromagnetic stimulation on patients in order to facilitate pain relief. As explained by plaintiff’s witness, John D’Angelo, MD, the process has nothing to do with MRI’s-magnetic resonance imaging.

Plaintiff bills $800.00 for each of these TMR treatments and recommends for most patients a series of four to five treatment sessions with a maximum of ten to twelve sessions. Plaintiff is seeking to be paid $4,000.00 for five treatments given to Russo on December 8, 10, 13, 15, & 17, 2010.

The treatments were submitted to GEICO under Code 64999 which is used for an “unlisted neurological procedure.” Apparently if plaintiff had submitted the treatments under a standard recognized electro-stimulation code, plaintiff would have been paid. However, under the standard code carriers are required to make payment at a rate substantially less than that for Code 64999.

Plaintiff apparently taking a cue from Miss Mazeppa, Electra & Tessie Tura of “Gypsy” fame who sang the above cited lyrics, has found “something special” in using the TMR 1200, a relatively unique pain management modality for the treatment of pain by the use of high frequency electromagnetically produced waves. Plaintiff testified that there are only about fifty such machines in use in the United States and the TMR 1200 device costs about $150,000.00. Although there are other similar devices available, plaintiff is using the [*3]TMR 1200 which is manufactured by Scientific Imaginetics.^[FN2]

When first confronted with the name of the machine the court pondered if a TMR 1200 was either a type of racing car, an alumni group from Ten Mile River Scout Camp, or the machine Marvin the Martian used to try to eliminate the Earth from blocking his view of Venus.^[FN3] Plaintiff quickly dispelled any of these misconceptions and while testifying on rebuttal described the science of the machine and how it was designed to be part of a comprehensive pain management program.

Defendant’s denial of the claim was based on a “Peer Review” conducted by Edward Weiland, MD, on January 11, 2011 in which Weiland concluded that the clinical status of Russo did not warrant “multiple therapeutic magnetic resonance high frequency electromagnetic post therapy treatments” and that the procedure “would not have accelerated claimant’s clinical recovery” from an accident on October 22, 2010.

On the trial date, Dr. Weiland was unavailable to testify and the defendant called Mitchell Weisman, MD as its “re-peer doctor” and expert witness testifying as to the lack of the medical necessity of the procedures rendered by plaintiff after having reviewed the same records as Weiland as well as Weiland’s report. It was stipulated that Weisman was an expert in the area of physical medicine and rehabilitation and that he could testify as the “Re-Peer Review” doctor.

Weisman agreed with Weiland’s conclusion that the procedure was not medically necessary. However, as an expert witness, Weisman opined that “TMR” and similar procedures are not generally accepted in the medical community as a valid treatment option. He stated that the normal electrical stimulation used in physical therapy is all that [*4]is required and that TMR and other high frequency based modalities are neither needed nor has it been established that they provide any benefit.

There are a few problems with defendant’s case. First, no where in his peer review does Weiland state that the TMR procedures were “not medically necessary.” He concludes that “medical justification has not been established.” The standard to be applied is lack of “medical necessity,” the term”medical justification” is not necessarily the same thing and does not meet the statutory/regulatory standard for evaluating the appropriateness of a treatment.

Second, although he recites the American Medical Association definition of “medical necessity” he fails to apply that definition to the specific facts of this claim.

Third, unlike Weisman who testified that TMR is not accepted in the medical community as a form of treatment, Weiland never addresses that issue, and implies that had there been some other documentation presented to him to review, he might have concluded that the procedures were necessary and that TMR is an appropriate treatment. Weiland justified his conclusion on the fact that there was no clinical basis for these treatments and that the customary modalities used in physical therapy should be sufficient to treat Russo.

The conclusions expressed by Weisman at trial cannot be accepted as they are beyond the scope of the Weiland Peer Review. Because Weiland never specifically found a “lack of medical necessity,” Weisman cannot amend that peer review to reach the conclusion that lack of medical necessity is the appropriate finding and thereby correct the deficiencies in the initial peer review report to which plaintiff was expected to respond at the trial..

Further, Weisman based his conclusion primarily on his assertion that TMR and similar treatments are not accepted in the medical community. It seems his opinion was secondarily, if at all, based on a lack of clinical findings to necessitate such treatments. Therefore, Weisman failed to reach his conclusion based on the same criteria used by Weiland. Weisman was in effect raising a new and different reason for denying payment, that is, the plaintiff’s seeking payment for a procedure not accepted in the medical community for the purpose used by the plaintiff. In general, plaintiffs are required only to rebut in litigation the grounds set forth in the denial by the carrier and not be surprised at trial by new grounds for rejecting payment of a claim.

The above being said these facts do create the interesting issue of whether the court can deny coverage and dismiss plaintiff’s cause of action based on the reasoning stated by the defendant’s expert at trial when the expert is testifying as to matters not used by the defendant to initially decline paying the claim. Weisman was qualified as an expert witness in the area of physical medicine and rehabilitation. The function of an “expert” is to provide the trier of fact with information that would be beyond the knowledge of the general public. Applying this standard, it would seem that the court could accept the [*5]expert’s testimony as to whether TMR is an accepted treatment protocol recognized in the medical community, especially when the expert is subject to cross-examination by plaintiff’s counsel; the plaintiff was present in court for the expert’s testimony; was called as a rebuttal witness and given the opportunity to challenge the conclusions of defendant’s expert.

What is also causing the court to question the appropriateness of the TMR 1200 electromagnetic therapy procedure is the apparent lack of any studies to show that the high frequency pulsed electromagnetic stimulation has any benefit to a patient such as Russo or that it is accepted in the medical community. The fact that plaintiff testified that there are only fifty machines in the United States would tend to support a conclusion either that the therapy is a new and emerging one as postulated by plaintiff and that he is on the cutting edge and ahead of the community curve, or that it is not accepted in the medical community and considered experimental at best, as advocated by the defendant.

The website of Scientific Imaginetics, the manufacturer of the TMR 1200 warns that “TMR is intended for temporary symptomatic relief of chronic intractable pain”it goes on to list as one of its nine “Warnings” that “the TMR has no proven curative value.” In the area “Contraindications” the manufacturer warns, “Never use the device when pain syndromes are undiagnosed until the etiology is established.” This contraindication is of particular interest because other than X-rays, taken in the emergency room on the date of the accident, there appears to have been no diagnostic or objective tests conducted on Russo so as to determine the cause of his pain. Linking it to a car accident, does not necessarily mean the etiology has been established.

In fact, Johns Hopkins Medicine/Johns Hopkins Healthcare in a report dated 3/15/12 instituted a policy that “High Frequency Pulsed Electromagnetic Stimulation (also known as therapeutic magnetic resonance)’ would not be authorized for “Treatment of soft tissue injuries.” A similar conclusion was reached by Aetna in a report dated 4/27/12. Although both of these reports are generated by insurance companies, no report contradicting these findings was produced by plaintiff^[FN4].

In order for a medical device such as the TMR 1200 to be “approved” for use by the Food and Drug Administration(FDA) the plaintiff must establish that:

there exists valid scientific evidence…which is sufficient to determine the

effectiveness of a device and from which it can fairly and responsibly be concluded by qualified experts that the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended or suggested in labeling the device [21 USCA §360c(a)(3)(B)(I)(ii)].

The FDA requires the person seeking approval of the device to provide adequate, well-controlled investigations which includes clinical investigations by qualified experts [*6]possessing scientific training and experience who could conclude that the device will have the effect it purports to have when used as directed [21 USCA §355(d)]. A device can be denied approval if the studies were not designed well, not quantifiable, and not otherwise conducted under applicable and essential principles of adequate, well-controlled clinical investigations [United States v An Article of Device…Diapulse, 768 F2d 826, 831 (1985)].

Plaintiff herein has failed to establish that the TMR 1200 is in fact FDA approved nor has plaintiff provided any independent studies to establish that this treatment modality is accepted in the medical community for the purposes for which plaintiff is using the device.However, the mere fact that the FDA has approved a device or procedure does not mean that the process is covered by insurance or Medicare [Svidler v US Dept of Health & Human Services, 2004 WL 2005781; Diapulse Corporation of America v Sebelius, 2010 WL 1037250 (EDNY)].

A similar issue as is presented in this litigation was before the United States District Court, Eastern District of New York, regarding whether the use of a device manufactured by Diapulse for treatment of persons by electromagnetic therapy would be covered under Medicare Part B [Diapulse Corporation of America v Sebelius, supra]. In regard to Medicare payments, the current status of such reimbursement requests is to be determined on a case by case basis. Medicare will not cover the electromagnetic therapy device but will cover the service provided by a physician or other medical clinician, thereby not allowing at home treatment. In this no-fault case the issue is not reimbursement for an “at home” device, it is for a physician provided service in the physicians office, which if a Medicare claim might be considered for payment.

For a service or a device to be covered by Medicare, it must be not only be safe, but also must be demonstrated as effective and generally accepted in the medical community, and an appropriate treatment [Estate of Aitken v Shalala, 986 F.Supp.57, 59 (Dist. Mass. 1997)].

As there are no reported cases involving electromagnetic therapy involving no-fault insurance claims nor are there any specific to the TMR 1200, the court is forced to analogize from these federal court rulings regarding other electromagnetic therapy protocols. It also would not make sense for one-third party source (Medicare) recognize that TMR treatments are reimbursable while another third party source(no-fault insurance) would find the treatments not covered based on lack of acceptance in the medical community. Either the procedure is accepted or it is not.

In rebuttal the physician who performed the TMR treatments, D’Angelo, explained how the process works and the benefits of using high frequency pulsed electromagnetic therapy to ease a patient’s pain. One of the reasons he recommends this treatment is that he believes it provides pain relief without the use of medication. Conceptually most people would agree that the less medication a person takes the better off they will be. However, as laudable as that goal may be, plaintiff in his rebuttal failed to reference any independent studies that document any real benefit from the TMR procedure. In fact, plaintiff did not [*7]articulate as to why this is a better protocol than regular low frequency electric stimulation therapy.

Clearly on a cost basis analysis justifying TMR that is billed at $800.00 a treatment session against the relatively low cost of the standard widely accepted electrical stimulation, which plaintiff testified is about $17.95 per session, and which most physical medicine practitioners utilize, is a huge burden to overcome. If that figure is accurate, a patient could undergo 44 regular electrical stimulation treatments for the cost of one by plaintiff using the TMR 1200 ^[FN5]. In a political and economic climate where rising health care costs are a concern to everyone, to require an insurance carrier to pay for treatments which are not widely accepted in the medical community and for which alternative less costly treatments are available does not make sense. Of course, this case has arisen in the “No-Fault Zone” where often procedures which either are non-emergency in nature or are being begun well after the date of the accident, are routinely paid by carriers when pre-approval would be required for the same treatments under any other type of insurance coverage.

Plaintiff testified that he recommends this procedure for patients who are not responding to conservative treatments. He asserts he is not recommending these treatments to patients who have experienced benefits from a conservative treatment plan. Yet the documents submitted in support of payment contradict that statement and reveal he is rendering these treatments within a relatively short period of time after the accident, often before the success of a standard course of treatment could be evaluated. In this case the accident was on October 22, 2010 and the first TMR treatment was on December 8, 2010, less than seven weeks later. There is no question that the injury received was related to the accident. The issue is whether the TMR is even recognized in the medical community as treatment for the injuries of Russo.

In light of this, the peer review physician Weiland, was correct in stating that such treatments are not “justified”either because less costly accepted treatment options had not been exhausted or from a cost/benefit analysis. It does not appear that cost standing alone is one of the criteria available to a carrier to disallow payment of a claim.

The court is reminded that science and improvements in medicine and health only advance when individuals are willing to experiment and take a chance on implementing new ideas and procedures. History is replete with examples such as Galileo Galilei who advocated a heliocentric solar system rather than the accepted thinking of his time of a geocentric one and was forced to recant his theories under the penalty of death; Edward Jenner who successfully developed a small pox vaccine and had to convince the medical establishment of its preventative abilities; or Joseph Lister who challenged the then current methods for treatment of wounds and promoted the use of antiseptics, and had the medical community accepted his teachings, perhaps James Garfield would not have died of the gunshot wound he received from Charles Guiteau. [*8]

On the other hand history is full of examples of “cures” for just about everything that “ails you” and hawked at “patent medicine shows” throughout America from real life examples such as Lydia Pickham’s Herb Medicine, Fletcher’s Castoria, and Kickapoo Indian Sagwa. To fictional ones like Al Capp’s “Kickapoo Joy Juice” from “Li’l Abner”; Jackie Gleason’s “Mother Fletcher’s” line of products; and “Pirelli’s Miracle Elixir” from Stephen Sondheim’s “Sweeney Todd.”

Conclusion:

Plaintiff should be encouraged to seek to find new treatments to benefit his patients. As noted by George and Ira Gershwin in “They All Laughed ^[FN6]” many people have had to advocate ideas and products which people at that time questioned but turned out to be accepted as the norm.

They all laughed at Christopher Columbus

When he said the world was round

They all laughed when Edison recorded sound

They all laughed at Wilbur and his brother

When they said that man could fly

They told Marconi

Wireless was phony

It’s all the same old cry….

They all laughed at Rockefeller Center

Now they’re fighting to get in

They all laughed at Whitney and his cotton gin

They all laughed at Fulton and his steamboat

Hershey and his chocolate bar

Ford and his misery

Kept the laughers busy

That’s how people are….

Plaintiff may be on the cutting edge of a new therapy treatment for soft tissue injuries and if he firmly believes that the procedure benefits his patients, should continue to provide the services, track the results and use his findings to convince the medical community of the benefits of electromagnetic therapy for persons with complaints similar to Russo’s.

Unfortunately, there is no evidence that high frequency electromagnetic therapy has been widely accepted in the medical community for the treatment of soft tissue injuries such as suffered by Russo in this accident. [*9]

Based on the fact that the defendant’s expert opined that the procedure is not accepted and that the plaintiff heard that testimony and had the opportunity to rebut it with evidence that it was accepted but failed to do so, the court must deny the claim for reimbursement.

In the event that the plaintiff can refute this presumption of nonacceptance with some independent recognized tests, the court will consider revisiting the issue in this or in another of the many open lawsuits for similar relief plaintiff has pending in this court.

Judgment for defendant. Plaintiff has failed to rebut defendant’s defense. Plaintiff’s cause of action is dismissed.

Exhibits, if any, will be available at the office of the clerk of the court thirty days after receipt of a copy of this decision.

The foregoing constitutes the decision and order of the court.

Dated:February 27, 2013

Staten Island, NYHON. PHILIP S. STRANIERE

Judge, Civil Court

ASN byon

Footnotes

Footnote 1:A rearrangement of the order of the lyrics to “You Gotta Have A Gimmick” from “Gypsy” Music by Jule Styne, Lyrics by Stephen Sondheim.

Footnote 2: Not to be confused with the TMR 1200 made by Patz and described as a vertical food mixer.

Footnote 3: Marvin actually used an Illudium Q-36 Explosive Space Modulator.

Footnote 4:It should be noted that the Aetna report does cite some studies where high-frequency pulsed electromagnetic stimulation has shown some benefits in wound healing and treatment of ulcers, Aetna denies coverage for all uses. Johns Hopkins recognizes for treatment of certain types of ulcers and certain wound therapies. Neither of them recognize it as beneficial for soft tissue injuries.

Footnote 5:By charging $800.00 for each treatment, plaintiff will recoup the cost of the TMR 1200 machine with 187.5 treatment sessions. Were plaintiff to have billed the service under standard electro-stimulation codes at $17.95 the machine would not be paid for until 8357 sessions had been completed.

Footnote 6:Written for the film “Shall We Dance” and sung by Fred Astaire.