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general and miscellaneous posts

The Next Big CAM Battle is Here and it’s Ugly

The Next Big CAM Battle is Here and it’s Ugly

CAM or integrative medicine doctors have had their problems with the state medical boards. And CAM organizations have had their run-ins with governmental agencies. However, the groups have always survived in large part because they have had a steady income from membership dues and from their annual conferences, where their members learn the latest and greatest from their thought leaders. But the CAM organizations’ income stream is now in jeopardy, and thus so is their existence, based on what looks to be well-planned, systematic effort to put CAM groups out of business, and stop the dissemination information about CAM therapies.

AND THAT MY FRIENDS IS A VERY BIG DEAL.

Here is what’s going on

For months, at least two CAM groups have been under review/ investigation by the primary private CME accrediting company, the ACCME (Accreditation Counsel for Continuing Medical Education). Recently, the ACCME has determined that a significant portion of the groups’ prior year’s CME courses does not meet various ACCME standards. ACCME is demanding that everyone involved in these courses be informed that:

“they were presented invalid information….”

and that the groups:

“instruct them [everyone] to avoid making any clinical decisions for testing and/or treatment based on what was presented, and
direct the registrants to accurate and valid sources of information for the problems or systems presented.”

I should point out that this “incorrect” information came from some of the most accomplished, respected and published thought leaders/teachers in the CAM community. These folks have been giving CME courses without incident for decades.

Further, in terms of future CME courses at their conferences, ACCME has informed these groups – and this is the key to understand what this is all about – that:

“recommendations involving clinical medicine must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients and all patient care recommendations must conform to evidence emanating from guidelines and data that meet generally accepted standards of experimental design, data collection, and analysis.”

In short, ACCME is trying to require these groups to only teach mainstream medicine! This is crazy and a huge deal!

Furthermore, the effect on the members of these organizations who attended the conferences last year and who used these courses to satisfy their state CME requirements is unclear.

I am not familiar with ACCME’s inner workings or guidelines, but it doesn’t seem out of the question that ACCME could contact state boards about these groups’ “noncompliance” and the retroactive withdrawal of CME credits. That could cause the state boards to retroactively hold the doctors non-CME compliant. I’m not saying that this will happen, but only that it’s a possibility. But I am saying that if the idea is to delegitimize CAM and cause problems for its practitioners, notifying the state boards would certainly advance that goal.

A specialty interest group also gets the same treatment

Beyond these two professional groups, a disease based group has recently been informed that its CME status for future conferences has been rescinded by its CME intermediary. The intermediary denies that it received any pressure or orders from ACCME.

Three CAM groups which have previously received ACCME course certification without any undue problems who in the last few months have had their prior CME course approval rescinded and/or their future CME approval withdrawn or placed in serious doubt.
Is this all a coincidence? Not a chance in hell.

My guess is that more of the same has or is going to happen to other CAM groups.

What to do?

At this stage, these groups need information about what’s behind this campaign to deny CME credit and delegitimize CAM teachings.

We need to get the word out to the CAM community.

Why?
Someone out there has to know something or know someone who knows something about how this came about, and who or what group is behind it. (My guess is that ACCME is the vehicle not the originator.)

I think there is a smoking gun out there, and if we find it, we can probably reverse ACCME’s decision quickly, so my suggestion is that all the CAM groups and interested parties get the word out to search for the smoking gun.

But let’s dig in to this and see if there is anything else that can be done. A logical place to start is:

What exactly is the ACCME and what does it do?

I don’t have any special info on ACCME, but here is what it says about itself:

“CME ACCREDITATION OF, BY, AND FOR THE PROFESSION OF MEDICINE.
The ACCME was founded in 1981 in order to create a national accreditation system. It is the successor to the Liaison Committee on Continuing Medical Education and the American Medical Association’s Committee on Accreditation of Continuing Medical Education. The ACCME’s purpose is to oversee a voluntary, self-regulatory process for the accreditation of institutions that provide continuing medical education (CME) and develop rigorous standards to ensure that CME activities across the country are independent, free from commercial bias, based on valid content, and effective in meeting physicians’ learning and practice needs. The ACCME accreditation process is of, by, and for the profession of medicine.
The ACCME’s founding and current member organizations are the American Board of Medical Specialties, the American Hospital Association, the American Medical Association, the Association of American Medical Colleges, the Association for Hospital Medical Education, the Council of Medical Specialty Societies, and the Federation of State Medical Boards of the United States.
Throughout its history, the ACCME has been dedicated to maintaining a relevant and responsive accreditation system that supports CME as a strategic asset to US health care quality and safety initiatives.”

Very noble and reassuring, isn’t it?

Basically, it’s a bunch of health care trade associations, organizations in charge of medical education and specialization credentialing. (Ironically, the medical specialty societies are the reason it’s illegal for practitioners to advertise their CAM board certifications.) And last but not least is CAM’s long-time adversary, the Federation of State Medical Boards. So maybe not so reassuring.

Did you know that the ACCME is accountable to the Public? Yea, just ask them and they will tell you so.

Here is what it says about that:

“Accountability to the Public
The ACCME is accountable to the public for setting and maintaining accreditation requirements that are designed to ensure that CME accredited within the ACCME system is based on valid content, is free from commercial influence or bias, and contributes to the quality and safety of health care. As the US health care system continues to evolve, the ACCME will respond by making changes to its requirements or processes that are necessary to assure that CME serves the best interests of the public.

I’m still not clear exactly how it is accountable to the public, and nothing in its web site gives any further elucidation.

I do have a couple ideas of how it might actually be made accountable to the public.

Some basic facts

It’s obviously a matter of individual state law what type of courses a state medical board will accept as acceptable CME. The ACCME might be the primary CME credentialer, but it is not the only one. For example, here is the Texas law regarding CME accreditation: It’s Board Rule 166.2 and it requires:

(1) At least 24 credits every 24 months are to be from formal courses that are:
(A) designated for AMA/PRA Category 1 credit by a CME sponsor accredited by the Accreditation Council for Continuing Medical Education or a state medical society recognized by the Committee for Review and Recognition of the Accreditation Council for Continuing Medical Education;
(B) approved for prescribed credit by the American Academy of Family Physicians;
(C) designated for AOA Category 1-A credit required for osteopathic physicians by an accredited CME sponsor approved by the American Osteopathic Association;
(D) approved by the Texas Medical Association based on standards established by the AMA for its Physician’s Recognition Award; or
(E) approved by the board for medical ethics and/or professional responsibility courses only.”

Other states have similar types of CME rules. The bottom line is that ACCME is a very important source of state approved CME accreditation, especially for everyone other than the major national and state medical trade groups. But there’s another way of looking at it. Without a state accepting its accreditation, ACCME doesn’t have much of a purpose or job.

What About CAM laws?

Texas, California and some other states recognize the rights of patients to receive CAM therapies. Texas, for example, provides that:

“The purpose of this chapter [Texas Board Rule Chapter 200] is to recognize that physicians should be allowed a reasonable and responsible degree of latitude in the kinds of therapies they offer their patients. The Board also recognizes that patients have a right to seek complementary and alternative therapies.” (Board Rule 200.1)

What are CAM therapies in Texas?

“(1) Complementary and Alternative Medicine–Those health care methods of diagnosis, treatment, or interventions that are not acknowledged to be conventional but that may be offered by some licensed physicians in addition to, or as an alternative to, conventional medicine, and that provide a reasonable potential for therapeutic gain in a patient’s medical condition and that are not reasonably outweighed by the risk of such methods.”

Convention medicine is defined as “Those health care methods of diagnosis, treatment, or interventions that are offered by most licensed physicians as generally accepted methods of routine practice, based upon medical training, experience and review of the peer reviewed scientific literature.”
(California has a similar definition of CAM at B&C code 2234.1)

So, Texas gives practitioners the right to provide non-conventional, not generally accepted therapies to patients, and patients have the right to receive these CAM or non-conventional therapies.

But even though Texas docs can provide CAM or non-standard therapies to Texas patients, ACCME now takes the position that Texas physicians can’t obtain CME credit for learning about these Texas sanctioned treatments. How can the ACCME be acting consistent with Texas law by its insistence that CAM medical groups can only teach:

“recommendations involving clinical medicine must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients and all patient care recommendations must conform to evidence emanating from guidelines and data that meet generally accepted standards of experimental design, data collection, and analysis.”

My view is that ACCME’s position is inconsistent, if not in violation of the Texas CAM Rule (and the California CAM statute) and probably every other state that has a CAM law.

So, what to do?

Complain to ACCME? Won’t hurt, but it won’t help. It’s doing what it’s doing intentionally, and some external pressure has to be brought forth.

Complain to the boards? Maybe, but it would take a lot of complaints.

In all the big CAM states like Texas and California, I know there are legislators who are pro CAM. My suggestion would be to identify who they are (not hard in Texas). I think the boards in a few of these states need to hear from some legislators about how ACCME is undercutting board rules (in Texas) or the CAM statutes (like in California).

These legislators should copy ACCME on their concerns expressed to the boards. If one of them is on a legislative health committee, even better. Better still would be for a couple states to start an investigation on ACCME’s motives. Maybe even an invitation to appear at a specially called hearing. Legislators can hold hearings for all kinds of reasons. So can federal legislators. I think with all the politically connected CAM docs out there, mulitipled by their politically connected patients, well I think there’s a heap of trouble that could be stirred up for ACCME.

It doesn’t have to happen in every state, or even many states, just a couple of the big ones. The story is going to get out, and questions are going to be raised. The widespread dissemination of ACCME’s action might even turn-up that smoking gun I mentioned earlier. And once the nefarious motive and scope of the conspiracy publicly surfaces, I think ACCME will be forced to rescind its actions. So, we need to shine some light on these jokers.

This could all happen pretty quickly if there’s a big enough outreach to the CAM community.

Something to think about anyway.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

Hey Mr. President: how about some quickie executive orders on prescription drug importing, stem cells, and vaccination

Hey Mr. President: how about some quickie executive orders on prescription drug importing, stem cells, and vaccination

Mr. President: looks like you’ve kept your word so far on Obamacare by signing a vague executive order allowing federal government agencies to do what they can to lower the costs or make more efficient whatever the agencies can figure out they can do without congressional approval. Hopefully that will work out.

I have a couple of ideas for some quickie executive orders, consistent with your campaign speeches or your thinking. As always, I’ll keep it short:

1. Consumers importing cheaper prescription drugs

Congress took up the issue, and since both parties are in the Pharma’s pocket, it once again declined the chance to help people by allowing them to import prescription drugs from Canada and other places where Pharma sells its products for a lot less money. You recently took Pharma to the woodshed in a recent tweet. On behalf of the people, thanks. In your inauguration speech, you railed against Congress for not watching out for us. Here’s my suggestions:

First: we need a standard Trumpian tweet excoriating Congress for protecting Pharma by its recent action in continuing the prohibition of patients from importing drugs manufactured by major drug companies which are sold for a lot less money abroad.

Second: how about an executive order ordering the FDA, DOJ and Customs not to enforce the existing drug importation restrictions. That would send a message to Pharma and Congress, as well as immediately save patients money.

Yes, you and the rest of the Republicans hassled Obama for using executive orders to circumvent enforcement of existing federal laws like immigration.

But let’s get real. That’s just an argument used by the party that doesn’t control the presidency. Further, I don’t think we should worry about little things like consistency. I’m guessing you’re okay with that, especially if some minor inconsistency can benefit the people who supported you, and trust me, your working class supporters will really appreciate having the option of cutting their out-of-pocket drug costs by half or more. You do this, and I guaranty your approval rating will jump-up a few points.

2. Stem Cells

Don, first thing I’d like you to do is call Rick Perry, and ask him about his experience in getting a stem cell transplant for his back problems. FYI, his stem cell procedure was flat-out illegal under federal law. But he was the Governor, so who was going to stop him? I’ve heard it helped him alot. If so, why shouldn’t the tens of thousands of patients who could similarly benefit from stem cell treatments get them? Do you really have to be a Governor to get the state-of-the-art treatment?

I’ve covered the FDA’s regulations and the technicalities in numerous prior posts,
http://rickjaffeesq.com/category/stemcells/

But the bottom line is that your FDA severely limits access to stem cell treatments, and you should do something about it immediately, even before the FDA Commissioner is identified or sworn-in. So here’s what I suggest:

First: A quickie executive order that whatever draft guidance documents concerning stem cells (and there are currently four, explained in prior posts, see above) are on hold, and no final guidance documents will be issued except on the approval of your FDA Commissioner.

Second: Another executive order that as matter of enforcement policy, neither the FDA nor the Department of Justice will take any action against a clinic which removes stem cells or any other human tissue from a person, and reinjects or reimplants that tissue into that person. And the enforcement policy should make clear that it applies even when the stem cells are other materials are expanded or cultured, which is the procedure which was so successful on Rick Perry. If Rick Perry could do it, let the rest of us have access to this stuff. (And BTW, there is less of or no consistency problem here since the regulations actually allow many stem cell treatments; it’s just the FDA has decided in its infinite unwisdom to try to stop almost all of these procedures.). The institutional stem cell players and the aforedescribed media cheerleaders won’t like it, but your supporters and many, many others will love you for it.

3. Vaccination

First: Let’s get moving on the Bobby Kennedy Jr. Vaccine/Autism thing. Maybe this could be done by executive order as well. Hell, it’s just a commission. I know you received some pushback from the institutional vaccine pushers and their cheerleaders in the media, but there is a groundswell of support for Bobby and the Commission from the people, and per your speech yesterday, that’s what important to you.

Second: as you probably know, federal agencies have some kind of internal oversight, referred to as the “OIG” (Office of Inspector General). In light of some of the recent stories about cover-ups and scientific fraud at the CDC concerning the autism issue, you need to give some serious consideration to the CDC OIG position. Your pick needs to be willing to take on the powers that be in the agency. So choose wisely.

Enjoy the job, and hope you really shake things up in the health care field. It’s long overdue!

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com

A short, mostly first-hand history on insurance reimbursement for CAM

A short, mostly first-hand history on insurance reimbursement for CAM

In litigating criminal and civil CAM (Complementary and Alternative Medicine) cases for three plus decades, I’ve seen a lot, and I have the medals and battle scars to prove it (meaning good and bad court opinions, jury verdicts and prosecutorial decisions). The decades have also given me a perspective on how things have changed, and haven’t.

For CAM insurance reimbursement (including chiropractic), I see one constant dynamic: Insurance carriers don’t like to pay for CAM services, so (some in) the CAM community come up with workarounds to get insurance companies to open-up their wallets. These workarounds work for a while, then they don’t, then there are new workarounds which work until they don’t, and so the dynamic goes.

Let me flush this out, largely based on my experience working on some of the big CAM insurance civil and criminal cases, investigations and medical board actions. Many of these matters were characterized by the government and/or carriers as “insurance fraud.” Fortunately, more often than not, the judge or fact finders didn’t agree, or at least didn’t think the government or carrier met its burden of proof.

CAM doesn’t get insurance reimbursement

In the 80’s, when CAM really started to take off, the carriers had short and vague exclusions in their policies about not paying for experimental or unconventional treatments/services. Even without specific definitions, those general policy exclusions were usually enough to stop most practitioners from filing claims or receiving reimbursement. Since most CAM treatments do not involve big money, individual patients and clinics did not litigate denials of claims for CAM treatments.

CAM figures out how to open the carriers’ wallets

A couple things happened in mid to late 80’s up until the early to mid-90’s which changed the CAM insurance payment landscape.

First, a few creative billing companies developed coding techniques to create some confusion about the nature of the services provided by CAM practitioners. One highly successful company made tens of millions of dollars for CAM clinics, and even obtained insurance payments for patients treated at Mexican CAM cancer clinics. They did this by creating chemo sounding acronyms for the treatments, and established a California based foundation for billing purposes which disguised the fact that the treatments were given in Mexico.

On the chiropractic front, a few chiropractor-turned consultants popularized the MD/DC business model, whereby chiropractic services were magically transformed into medical care. This regulatory alchemy was based on an obscure Medicare concept called “incident to” billing, the effect of which was to circumvent the severe limitations which most carriers placed of chiropractic care. These rules were also used to bill services of unlicensed people giving advice about “activities of daily living” as incident to services rendered by or under the MD’s provider number. Because of the efforts of these billing companies and consultants, tens of thousands of patients received care paid for by carriers which would have otherwise been denied by the greedy and heartless insurers. (I might not be unbiased.)
From the government’s and carriers’ point of view, it was all insurance fraud. It was relatively hard to prosecute insurance fraud back then, federally at least. Most of the victims were private carriers. There wasn’t much of a federal budget for these prosecutions, except for the most high profile or unlucky cases. (I worked on one of the big cases involving an unlucky and high profile doc.)

In addition, there were some impressive legal victories wherein carriers were forced to pay-out big judgments (including punitive damage awards) for denying expensive investigational or CAM cancer treatments. These judgement caused some shock waves in the health insurance industry and led to some very significant changes in the legal/regulatory/enforcement landscape.

The carriers and feds fight back hard

The carriers figured out that they were not paying for reimbursable conventional care, but rather, excluded CAM care. They were not happy and some started filing lawsuits against the practitioners and even the consultants and billing companies. The carriers also got the feds involved.
Federal prosecutions of insurance fraud became easier and more frequent because of a provision in the 1996 HIPAA law which made health care fraud against a private carrier a federal crime. (18 USC 1347, for those who care). The new law even made medically unnecessary testing and services prosecutable under the federal insurance fraud statute. With the change in the law came some significant federal money to fund federal insurance fraud prosecutions.

I worked on some of the major health insurance civil and criminal health care fraud cases in the 90’s. Mostly the results for my clients were good, but even so, as they say in criminal defense, “You can beat the rap, but you can’t beat the ride.” These cases were brutal and draining for the docs. And when the doc loses, he loses big; his/her medical license and freedom for a time. So the stakes in these cases are huge.

Civil lawsuits against health insurance carriers for non-payment of arguably experimental or unapproved care virtually ended in the 90’s once the carriers figured out that they could use ERISA (employment law) to make these cases unattractive and almost unwinnable by plaintiffs’ attorneys. (In short, ERISA law makes the carriers’ payment decision judicially reviewed under an extremely high abuse of discretion standard. Also, there are no punitive damages in ERISA, thereby removing a big incentive for the plaintiffs’ bar to file these cases.)
On the MD/DC front, the carriers and the feds fought back hard. Aetna went after one of the main MD/DC consultants and the MD/rubber stamp of 50 of the MD/DC clinics in the northeast.

The feds started prosecuting many of the chiropractor owners of the MD/DC clinics and their MD and DC employees. In the early 2000’s, the feds went after the most visible MD/DC consultant and one of his client-clinics in northern West Virginia. The chiro clinic owner got wind of the investigation and fled the country, but the MD, the two employee chiropractors, the office manager and the consultant who set the operation and told them how to bill the carriers were all indicted for insurance fraud.

The MD and office manager plead-out and did some time. The two chiros and the consultant went to trial, but all were convicted. The consultant was also convicted on money laundering charges, which is a very nasty crime because it imposes an unusually harsh sentence, far greater than mere insurance fraud. Despite three appeals, the consultant received a very lengthy prison sentence, and there’s no parole in federal time. This was the worst result I ever received in a case. The government would say that this person was responsible for many millions of dollars of insurance fraud and that he was fairly punished. (The chiro clinic owner who fled the country beat the government’s extradition efforts and continues to live in Ireland.)

This and the other prosecutions reduced the popularity of that MD/DC clinic model. One of the big CAM billing companies was eventually indicted, but the case was ultimately settled and charges dropped. A few docs were eventually indicted and there were some convictions, but nothing like in the MD/DC field.
In the mid 2000’s, there were still some MD/DC clinics but most were operating below the radar screen, and didn’t engaged in the most controversial forms of billing that the prior chiropractic consultants advocated.
Some CAM physicians continued to engage in the obfuscation techniques taught by the CAM billing consultants, but for whatever reason, there wasn’t much activity on the federal criminal front. I worked on an investigation of an autism clinic which used a billing technique to circumvent the carriers’ pathway edits for unconventional autism treatment. Eventually, the carries figured it out and contacted the feds which opened up a grand jury investigation. All I’ll say is that it’s a case you’ve never heard of because there was no indictment. But the clinic did close its doors once the carriers figured out what it was up to.

Also, starting in the mid- 2000’s there began to be a movement in the CAM community to produce specific codes for CAM services. It was called ABC billing (Alternative Billing Concepts). The idea was to create HCPCS type codes which could be used in billing insurance companies for CAM services. My take is that it’s had some success, but not for the primary therapy types of CAM like chelation therapy, environmental therapy treatments, and such.
The problem with the ABC endeavor is that it misunderstands the main reason why CAM practitioners aren’t getting paid for the CAM primary therapy. It’s not because, there is not a specific enough CPT or HCPCS code which is what the ABC codes try to solve. Rather, it’s because most carriers have a policy against paying for treatments not generally accepted by the conventional medical community.

To be fair, carriers do pay for some CAM therapies like acupuncture, chiropractic and even nutrition counseling (given by a properly credentialed provider), but 1. The reimbursement rates for these services are low and 2. That doesn’t help the integrative practitioner who uses a wide variety of primary therapeutic CAM modalities which are not payable under the plans.
So however laudable the ABC coding effort is, it won’t solve the CAM practitioners’ main problem, which is insurance policy exclusion of most or all primary CAM treatment modalities.

What comes around and goes, comes around again

In the last few years, a new billing and coding model has been promoted to the CAM community by various CAM coding companies. It involves use of an arcane Medicare concept, the “incident to” rules, which turn services of NPP (non physician practitioners) and chiropractors into physician services in order to 1. Obtain 100% physician reimbursement rates, rather than the 85% rate of NPP’s, 2. To circumvent the limitations of chiropratic in Medicare and third party pay plans, and 3. To bill people without any health care license or certification under as services of the MD provider. What a novel approach!
In the old days, Medicare had more rigorous and restrictive payment practices than all private carriers, so following Medicare’s rules was in effect, a safe-harbor or guaranty of compliance with the rules of the private pay carriers. However, those days are gone. Some private health insurance have stricter rules than Medicare and/or don’t follow all of Medicare’s rules. So the Medicare safe harbor concept doesn’t necessarily work anymore.
These new CAM billing companies also have some novel interpretations of various other codes, which, it is claimed, obtains insurance reimbursement for primary CAM therapies such as chelation therapy for heart conditions and even detox. You can probably guess some of the ways they achieve these results.

IN SHORT
If you are following the advice of one these billing companies, keep this in mind; just because the carriers’ payment computer programs are spitting-out checks to you for CAM treatments doesn’t mean the carriers actually know what they are paying for, or that they won’t ask for their money back, if and when they ever figure out what’s going on.
And on it goes.

Rick Jaffe, Esq.
rickjaffeesquire@gmail.com
www.rickjaffe.com