December 22, 2004

Resident Choice of Pharmacy vs. Facility Choice of Medication Distribution System

Do you use a pharmacy that has adopted the Opus system or a similar system? Have you specified that any pharmacy who does business with your facility must use the Opus system including the part where the pharmacist generates the MARS and physician order forms and provides other services?

If so, you may run afoul of DADS. Recently, a facility was cited for having such requirements on the basis that this is a violation of resident rights. As you know Rule 19.1502, Choice of Pharmacy states:

A Medicaid-certified facility must have written agreements with its provider pharmacies that define required services. These agreements will not be considered to abridge the resident's freedom of choice of pharmacy services when they require labeling, packaging, and a drug-distribution system according to facility policy. The drug-distribution system must be accessible to all pharmacies willing to meet the distribution system requirements. The agreements must require the following:

(1) that the resident's pharmacy services be provided by a pharmacy on a 24-hour basis for emergency medications; and

(2) that the resident's medications be delivered to the facility on a timely and reasonable basis.

(c) The resident's choice of pharmacy provider must be in accordance with §19.406(c) of this title (relating to Free Choice).
(emphasis added)

According to a source, the legal department at DADS reads this to mean that requiring pharmacies to have the ability to generate the MARS and physician order forms is too expensive a requirement for many "Mom and Pop" pharmacies. DADS , thus, takes the position that you can't require that pharmacies go over and above what the standards require or you are unduly restricting the resident's choice of pharmacies.

I have a few questions for DADS about this. How are you defining a labeling, packaging and drug distribution system? Are you saying that any pharmacy system that does more than providing services on a 24 hour basis and delivering on a timely basis to be over an above the standards? I'll try to find this out and will report back.

Word of warning: If any of you have changed to this system and have, as a result, made a local pharmacist mad--beware.

They're After Aleve Now

Doubtless, you've all heard the news about Vioxx and Celebrex and the allegation that those drugs increase the risk of heart attack or stroke. Now an Alzheimer's Prevention Study is being halted because Aleve, one of the medications they are using in the study, contains naproxen, the same ingredient contained in Celebrex. The subjects of the study were being administered Aleve, Celebrex or a placebo. I cringe to imagine of the activity going on in offices of plaintiff's personal injury lawyers over these revelations.

In fact, I don't really have to imagine. After the news about Vioxx came out, I received a letter from one of these lawyers, essentially soliciting potential clients who might have heart problems and who have been taking Vioxx. In case you didn't know this, plaintiff's lawyers send these kinds of letters out to other lawyers all the time.

All I can say is that there is NO drug without risks. That's why physicians are involved in prescribing drugs like Vioxx and Celebrex. Most patients benefit greatly from these drugs. It's a miniscule few who have adverse affects.

The fact that the few is miniscule will not stop predatory lawyers from attempting to feed on the bodies of the pharmaceutical companies making these drugs. And, it is probable that most of the cases will involve people who have heart problems because they are old. These same people will have arthritic pain because they are old. But the plaintiff's personal injury lawyers will find expert witnesses willing to prostitute themselves to testify that the drugs caused the heart problems. That's how it works in the realm of products liability.

If you think that the Pharmaceutical Industry is evil, go read this article written for Harper's Magazine by Mark Twain about the state of health care in 1890 when they were still using leeches for everything. (Hat tip Dr. Charles)

You want true tort reform? Figure out how to stop State-funded law schools from pumping out so many lawyers.

"Who's on First?" regarding Employee Misconduct Registry Appeals at APS

The State reorganization was bound to cause some confusion as agencies reformat and try to fill in the gaps forgotten by the Legislature. We've had occasion to look into the issue of what is going to happen to the appeals that concern placement of an employee on the Employment Misconduct Registery. It appears that these appeals are in limbo right now.

Our sources at some of the agencies tell us that Department of Family Protective Services does not want to hear these appeals itself. It wants another agency to hear them. I say good for DFPS!!

The problem is that Chapter 253 of the Texas Health & Safety Code seems to require that these appeals be heard by the agency that made the determination. This requirement poses a conflict of interest even if you have a totally fair Administrative Law Judge.

There is some talk that DFPS is trying to convince HHSC to hear the appeals. If that happens, they will probably be shipped off to SOAH.

That's the best thing that could happen in my opinion.

December 16, 2004

Double Penalties

If you have a pending nursing home Civil Penalty case based on a survey that predates September 1, 2003 and you have already paid a Federal Civil Monetary penalty, the Fort Worth Court of Appeals has rendered a favorable decision. The case is The State of Texas v. Haltom Medical Investors, L.L.C. d/b/a Haltom Convalescent Center.

The facts of the case involve a survey done in July, 2002 which resulted in a recommendation of Federal Civil Money Penalties and a referral to the Texas Attorney General for Civil Penalties. The CMP's and Civil Penalties were to arise from the same facts. The nursing home accepted the Federal waiver and paid the reduced CMP amount. In January of 2003, DHS got around to sending a letter to the Texas Attorney General referring the matter for Civil Penalties.

On September 17, 2003, the OAG filed suit. The problem for the State is that during the 2003 Legislative session, the Texas Legislature changed section 242.070 to read:

The department may not assess more than one monetary penalty under this chapter and Chapter 32, Human Resources Code, for a violation arising out of the same act or failure to act, except as provided by Section 242.0665(c). The department may assess the greater of a monetary penalty under this chapter or a monetary penalty under Chapter 32, Human Resources Code, for the same act or failure to act.

The nursing home had already paid the CMP and argued that the changes in the law which were effective on September 1, 2003 precluded the State from collecting additional monetary penalties. The State argued that the Civil Penalties were assessed in 2002 before the change in the law and that the prior law applied allowing the State to collect additional monetary penalties. Apparently, the State's idea of assessment was the letter sent with the 2567 indicating that DHS was recommending referral to the OAG for imposition of Civil Penalties. Of course, there was no notice in the letter about how much the Civil Penalties would be or for which violations the CP's were being pursued.

The OAG also argued that giving notice that the State was seeking Civil Penalties is the same as assessing them. The trial court and Court of Appeals decided otherwise. The Court of Appeals looked at the Health & Safety Code, section 242.067(g) which says:

If the person charged with the violation consents to the administrative penalty recommended by the department, does not timely respond to a notice sent under Subsection (c) or (e), or fails to correct the violation to the department’s satisfaction, the commissioner or the commissioner’s designee shall assess the administrative penalty recommended by the department.

Also, the 2002 TDHS annual report to the Texas legislature interprets the term assess differently from the State's argument against Haltom. It says:

Penalties assessed are the final actions after the appeal process has been completed (or an agreement to settle has been reached) and a final amount has been decided. The facility is notified of the amount to be paid. There may be a lump sum payment or a monthly payment scheme agreed upon during the appeal or settlement process.

Thus, it appears that if the OAG hasn't already collected or settled a Civil Penalty matter pending from a pre-September 1, 2003 survey--and the facility has already paid a CMP, the State is out of luck according to this decision.

The case was delivered on December 9, 2004. I'll continue to watch it in case further motions or appeals overturn the decision.

December 05, 2004

Adjusting To The Medicare Drug Prescription Plan

The Robert Pear from the New York Times has published a piece opining that confusion will be caused by the fact that the Medicare Drug Prescription Plan may cause confusion for nursing home residents as a result of the fact that residents will be allowed to choose between two or more government subsidized plans. The article states:

The premise of the law is that Medicare beneficiaries will carefully compare these plans and enroll in the ones that best meet their needs.

But more than one-third of nursing home residents have Alzheimer's disease or another form of dementia, so they cannot easily compare the costs and benefits of different plans.

Bush administration officials said they were seeking ways to meet the special needs of nursing home residents. Dr. Mark McClellan, administrator of the Centers for Medicare and Medicaid Services, said the administration would ensure that beneficiaries had access to "all medically necessary drugs."


Pharmacists express dismay at the prospect that nursing home patients will be in different drug plans covering different medicines.

"If nursing homes have to deal with multiple formularies from multiple prescription drug plans, that will result in chaos and an increased potential for medication errors," said Thomas Clark, policy director for the American Society of Consultant Pharmacists, whose 7,000 members specialize in drug care for the elderly.

My suggestion is to review your policies and procedures to deal with the issue. If you have a plan in place in anticipation of these issues, it is doubtful that chaos and medication errors will be the rule rather than the exception at your facility.