Friday, October 30, 2009

DEA On-Site Investigation of Suboxone Prescribing Physicians

I just got off the phone with a pleasant representative of DEA who fielded some of my questions about the (apparently) imminent site visits by DEA agents to... Actually, she never told me the purpose, but I suspect they intend to monitor compliance of doctors prescribing Suboxone and Subutex for opiate withdrawal and maintenance with the law: DATA 2000.

DEA may have started these visits, but I have found no reports. If anyone has experienced an on-site investigation, please describe the experience by commenting here.

Not knowing how such a visit will proceed my fantasies run wild, and I still have numerous questions about this potentially disruptive plan. Mostly the DEA representative referred me to the law which lists requirements regarding record keeping and the 30/100 patient limits. She told me the visit will be unannounced, and that if I am not there when the investigators arrive, they will probably return later. She said they would try to maintain a low profile, but did not directly address many of my questions:

Should we notify patients now to give them an opportunity to object? How long will it take? Suppose I have to leave before they finish? Will we be allowed to de-identify the records? If the investigators demand access to electronic records, do we have to let them use or access computers or hard drives? (She said they just need access.) What if my digital media contain records of patients not prescribed buprenorphine? (She said they will not want to see records of patients not prescribed buprenorphine.) What questions will be asked? If I refuse to answer questions or provide access when demanded, what will happen?

I did not ask why the DEA would want to investigate doctors like me who are treating opiate addiction rather than doctors who are prescribing the drugs that are killing our patients, like OxyContin and methadone. I admit to a cynical drift here, but could it be that we threaten their livelihood? Lots of addicts equals job security for DEA employees. And if we legalize pot...

DEA Audits: insensitivity and disrespect

Thursday, October 29, 2009

Is Generic Buprenorphine Approval Another FDA Blunder?

Suboxone maintenance patients will likely rejoice almost as much as third party payers over the imminent availability of a generic, but the FDA should not make buprenorphine available until after the combination buprenorphine/naloxone (Suboxone).

The idea of combining naloxone, an opiate antagonist that can only act when injected, with the mu opioid partial agonist buprenorphine for treatment of opiate addiction is to discourage addicts from injecting the drug to get high. Standard practice calls for use of buprenorphine alone (Subutex) only during pregnancy and a few other situations where it is possible that the naloxone contributes to rare adverse effects. Although I cannot claim to have priced these drugs on the street I suspect buprenorphine brings a higher price, and many of my patients have attempted to get me to prescribe it for dubious reasons.

Given the high price of Suboxone and Subutex in the pharmacies we have all eagerly awaited the arrival of cheaper alternatives. While I am glad more patients will be able to afford treatment with adequate doses, I believe many will want to switch from Suboxone to generic buprenorphine, and that this will lead to more abuse and diversion. Delay in release of the buprenorphine until after release of the combination could have prevented this. What could the FDA have been thinking?

Increase in buprenorphine availability accompanied by lower price on the street may also lead more addicts to attempt to treat themselves rather than incurring the expense of medical supervision. And since many patients (and even a few docs) seem to wrongly assume that precipitated withdrawal results from the naloxone, we may see an increase in that phenomenon when naive addicts use the drug too soon after stopping whichever full agonist they were dependent upon.

Let us hope the FDA approves a generic buprenorphine/naloxone product post haste and that its price makes it just as much of a bargain as buprenorphine alone for saving lives. And do not switch from the combination to the new generic for financial reasons alone.

Wednesday, October 21, 2009

Paying for Interpreters is Just the Beginning

When a New Jersey court decided the case of Gerena v. Fogari just over a year ago many hailed the verdict as a win for disabled people arguing that it would send a message to doctors and others that they must provide, and in many cases pay for, sign language interpreters for hearing impaired patients (clients). But I believe the fact that the physician might actually lose money for the privilege of treating the hearing impaired patient will result in physicians looking for ways to avoid treating them at all. This unfunded mandate from the US government will lead to more rather than fewer problems for people with disabilities.

The AMA reported on the case here. Briefly, Dr. Fogari, who, if he's the same Dr. Fogari reported on here, seems to have more than his share of problems, elected not to hire a sign language interpreter to assist in communicating with his hearing impaired patient Gerena. She sued for discrimination, not malpractice, and was award substantial punitive damages. Because Medicare limits what he can collect Dr. Fogari would have had to pay an interpreter (whose fee is not limited) as much as 3-4 times as much, for a net loss of $100 - $150 for each of Ms. Gerena's visits. (This may be another good reason to opt out of Medicare, or just refuse to treat patients covered by Medicare.) Apparently judge and jury thought Dr. Fogari enjoyed enough income to spread the cost among among his entire patient load without hardship.

Whether Dr. Fogari could afford to lose money in caring for Ms. Gerena is beside the point. The essence of any professional relationship is that a service is provided for a fee, and medical ethics has always held that a physician, except perhaps in an emergency, must be able to choose whom to treat. My understanding of the rationale for this is that both physician and patient can suffer when the relationship is forced, regardless of whether the source of dislike for the patient is financial or otherwise. Even providing free treatment can raise questions about the physician's motivation in providing the care, and the patient should wonder whether she really wants care from a physician who might resent providing that care. There must be a give and take.

But suppose the physician elects to take on such a case. Now he may feel stuck with the patient and may resent it. It seems likely that the courts will assume that discharging constitutes unlawful discrimination, and punish the physician accordingly. Suppose the patient demands a prescription for Oxycontin, fails to keep appointments, or otherwise makes a nuisance of herself. The physician may feel pressured to give in to avoid getting in trouble. This threat gives the patient too much power to manipulate the physician.

Let us say you, the physician, get a call from a family member to schedule an initial office visit for their hearing impaired relative. I suggest you make the appointment at least several weeks out, because you will have a lot of preparation ahead of you. First you must decide whether to hire a professional interpreter or to use a family member. I would argue that, although probably free of charge, you cannot accept a family member. You will not know the family member's level of competence, and if a misunderstanding leads to a bad outcome, you may be liable. Furthermore, the patient may not want to share personal information with a family member. The patient may authorize release of information, but the physician has no way of knowing whether the patient has been candid, not too mention that the family member can censor what the patient "says" unbeknownst to the physician.

Having decide to use a professional sign language interpreter, now you must choose one. Although you may want to consider the recommendation of the patient, remember that you will likely be held responsible for the outcome. Consider interviewing several candidates and obtaining references before choosing.

And now comes the disclaimer: I am not an attorney. This does not constitute legal (or medical) advice. Maybe the first thing to do when that patient calls you is for you to contact an attorney to advise you on these issues and any others I may have overlooked.

Having selected an interpreter you must now negotiate the terms of the contract. Expect to pay for travel time and expense as well as waiting time. Expect also to pay even if the patient does not show up. If you like to take risks you might try demanding that the patient pay the no show fee. Of course you will need to decide how to handle the situation in which the patient appears but the interpreter does not. You will probably want to reschedule. Some interpreters may work via Internet video feed, but will this meet standard of care? Is this telemedicine? Will it increase your liability?

You must attend to some other matters. According to the Department of Labor and Industries in my state (WA), if a contractor like your interpreter gets hurt while working for you and has not purchased worker's compensation coverage, you must pay his medical expenses and possibly time loss compensation. Just like when hiring a contractor to work on your home you should require the interpreter to provide written proof of coverage.

Remember that your patient and you will reveal protected health information to the interpreter during the visit. You should consider obtaining written authorization from the patient for you to release information to the interpreter. Here you will face a Catch 22: You should have signed authorization before the interpreter gets involved in the conversation, but you will not be able to communicate with the patient (except in writing) about the authorization until the interpreter is present. Furthermore, if you meet the criteria for a covered entity, HIPAA probably requires that you have a business associate agreement with the interpreter.

Finally, consider the outcome if the interpreter negligently misinterprets resulting directly in injury to your patient. I do not know whether interpreter's can even purchase malpractice insurance. Even if the interpreter has insurance the patient will likely name you in a malpractice suit because you have the deep pocket. Consider requiring the interpreter to sign an agreement to indemnify you in such a situation. You may also want to require the interpreter to provide you with written evidence of current professional liability coverage, and the limits of liability.

Physicians should also consider how to handle contacts outside of office hours. Do you know how to use TTY? Will a physician covering your practice in your absence know how to manage?

All this probably really makes you eager to take care of hearing impaired patients. But do not expect any of this to go smoothly. A few months ago I contacted the local office of Interpreter Network to inquire about some of the issues above. After several attempts by phone and email I received a curt message from Robbi Crocett, the Executive Director, who seemed to have no grasp of the need for worker's compensation coverage for contractors ("... we are not under the L&I contract so this would be billed directly to your office..") and was unaware of the HIPAA requirement for a business associate agreement ("... we are familiar with HIPPA regulation and this is a clause that was listed in the Terms and Conditions...").

As I believe is true of most health care related legislation, neglect of reality by lawmakers leads to opportunity for attorneys and more problems for others. Misguided judges and juries compound the problems. This legislation should have provided reimbursement for interpreters by payers, including private insurers (as I understand may now be required now in California). The verdict in Gerena v. Fogari likewise may have helped Gerena and her attorney but will likely hurt rather than help hearing impaired people, like my own father, and others with disabilities. I believe Dr. Fogari should have argued that it would be unethical for him to operate at a financial loss in caring for Ms. Gerena. I hope he will appeal.

Sign language interpreters serving in medical settings should be subjected to certification and licensure requirements just like health care professionals. And when the physician's fee is restricted, so should the interpreter's.

Physicians often effectively advocate for people with disabilities. Many of you are our patients. Attacking them will turn them from friends into enemies.We should all share in costs associated with accommodation of disabilities, and all disabled patients, not just those whose physicians can afford it, should be accommodated. Physicians are not the financial "bailout" for a failing health care system or for those with disabilities.

Thursday, October 8, 2009

The Mystery of the Denied Refill Requests

Voicemail: "Hello doctor. This is Mr. Smith. The pharmacist said you denied my refill for Suboxone."

That's odd. Mr. Smith never called to ask me to order a refill from the pharmacy. The pharmacy never contacted me to ask me to authorize a refill for Mr. Smith. Why would they think I denied it?

This mystery has haunted my practice for a year. Come to think of it, that pretty much coincides with how long I have been ordering most prescriptions (all but controlled substances) online. I signed up with both and about a year ago, hoping to gain enough experience to decide which I like better and maybe write an article comparing the two. But as I found myself preparing for a two-week absence from the office for vacation I realized I needed to simplify, so I quit using Allscripts and have been using Iscribe exclusively ever since. In a phone call to the customer service line at Iscribe yesterday I may have heard the solution to the mystery.

Generally when these mystery denials have taken place the pharmacists have offered no explanation, however a few months ago a pharmacist told me that a message had appeared either on the pharmacy computer or the pharmacy fax machine, and agreed to fax me a copy. Sure enough, there was a message indicating the request had been rejected. The patient's name, my name, and the drug were printed thereon, but there was no indication whatsoever of the source of the message.

I began to ask other pharmacists and to talk to my patients about the problem. One pharmacist suggested that an automated telephone prescription refill system might have generated the mystery messages, but some of my patients said they talked directly with pharmacists when they requested refills. Another pharmacist suggested the problem might be with an e-prescribing service. Regulations still prevent ordering controlled substances using Iscribe, and I understood that only renewal requests for non-controlled substances could be communicated to me using Iscribe.

A couple weeks ago, however, I was pleasantly surprised to receive some electronic requests for refills for Suboxone on Iscribe for the first time. This has become my favorite way to recieve refill requests. Typically an email message notifies me that a renewal request has arrived. I log in to my Iscribe account. A couple clicks, and it's done. Of course I was not able to authorize these Suboxone refills online. This is still not allowed. I could print a paper prescription, but since the patient is not present that does not help. Instead, I fax the prescription to the pharmacy as I would routinely. This brings me to the phone call to Iscribe. I asked the representative whether there might be a way to remove the renewal request from the inbox without printing it. In responding he mentioned that Iscribe had changed the system because of unwanted denials.

We may never know the truth, but it appears to me that, either through an automated phone system or initiated by a pharmacist, Iscribe generated the denials unbeknownst to me and with no indication of where the denials originated. It has been my understanding that e-prescribing services such as Iscribe and Allscripts use a clearinghouse, possibly, as an intermediary with pharmacies. My best guess now is that, after the patient asked the pharmacist for a refill, the pharmacist, rather than contacting me by fax, entered the request through the clearinghouse which identified me as participating with Iscribe. At that point either the clearinghouse or Iscribe rejected the request automatically because the drug is a control substance, without notifying me. The pharmacist thought I had generated the rejection.

E-prescribing promises many advantages over paper, phone and fax orders, but designers need to correct potential stumbling blocks quickly when identified. We will see whether the mystery denials stop.