Sunshine Act’s Open Payment System To Physicians and Teaching Hospitals Launches Nearly On Schedule With Only Partial Data.

I once helped teach medical statistics. Much dark humor and many aphorisms were to be heard. For example: “If you torture the data long enough, it will tell you what you want to hear.” Another, “Garbage in — Garbage out,” is a shorthand way of stressing the importance of data integrity and reliability. If the data is not well defined, collected, accessible, or verifiable then any subsequent conclusions are correspondingly suspect. In the age of “big-data” and transparency of medical information, this latter concept of data reliability should be guarding the door of accountability. I suggest that the standards being applied so far by CMS to data collection would not be acceptable to editors of scientific journals and yet publication is going forward. Here is what CMS is saying about its Open Payment System:

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Rocky Rollout of Sunshine Act— The Open Payments Program for Physicians.

Another Accountable Care Act initiative with website problems!

For many years now, many public policy concerns have been expressed about the huge amounts of money that pharmaceutical companies and medical device manufacturers give directly to physicians and academic medical centers. An old drug detail-man in Kentucky once told me his company gave Cadillacs to the highest prescribers of his drugs. I doubt that things are that blatant anymore, but so much money flows into individual and departmental pockets that it is difficult to assemble members for expert panels of the FDA, CDC, or other policymaking organizations who are not receiving money from drug and device makers. Full disclosure was supposed to solve the problem, but that does not work. The Open Payments initiative is part of a larger movement for greater transparency and accountability. I plan to write more about this, including my own experience over the years interacting with Pig Pharma and Big Devices.

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Stopgap Bill to Provide Healthcare to Veterans Passed by Congress.

Last week, Congress finally sent to the President the “Veterans Access, Choice, and Accountability Act of 2014.” While the “accountability” in this title refers to making heads roll among the administration of the Veterans Administration, there was clearly some embarrassment and a deficit of legislative accountability that forced a dragging-and-kicking pair of adversarial political parties to agree to bail out a Veterans Administration that had been negligently and predictably starved into delinquency.

Vets couldn’t get timely appointments.
The substance of the bill deals almost entirely with the problem that veterans were facing unacceptably long delays in obtaining appointments for medical services. Not unexpectedly, a few items from the larger mouldering VA appropriation bills were tacked on. Since these were presumably items that were easy to agree on, I predict that passing the rest of the necessary VA legislation will become even more difficult, if it passes at all. Continue reading

Kentucky Attorney General Moves to Intervene in Norton- UofL- Kosair Disputes over Children’s Hospital.

[Updated in Comments Aug 23, 2014]

Next week, Kentucky’s Attorney General will plead in Jefferson and Franklin County Circuit Courts to be added as an intervening defendant in the disputes between Norton Healthcare and the University of Louisville over control of Norton Kosair Children’s Hospital, and that between Kosair Charities and Norton over the use of charitable contributions and the right to raise money in the name of the hospital. The outcomes will ultimately determine the relationships (or lack thereof) between Norton, Kosair, and the University. Relations have not been going well in recent years with UofL seeking to switch its pediatric activities from Norton to KentuckyOne Health, and Kosair charities moving to substitute UofL for Norton as a chief beneficiary of its charity. Continue reading

Why Is There Only One NCI Cancer Center in Louisville?

In Reporter Michael McKay’s account of the UofL Board meeting earlier this month when progress towards the University’s 2020 Plan was summarized, and when the post-fraud “Audit” was formally presented; President James Ramsey commented on the University’s failure to earn a National Cancer Institute (NCI) designation for its James Graham Brown Cancer Center. Dr. Ramsey stated that it was unlikely that UofL would receive an NCI designation because the UK program is so close. (The Markey Cancer Center at the University of Kentucky was designated as an NCI Comprehensive Cancer Center in 2013.) Dr. Ramsey is said to have implied that UofL had been in talks for some sort of “partnership” with UK before that institution went on its way alone. These comments sound more to me like excuses than explanations. I found nothing in the NCI application documents that would indicate that distance from another center would be a factor. Indeed, depth of collaborations with other research and clinical centers is highly desirable if not essential.

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KentuckyOne Health Is More Than “Talking” with Tenet Healthcare.

In with both feet. But how far?

26 July 2014, 3:30 pm

Reports that KentuckyOne Health was talking with Community Health Systems of Nashville about the sale of Jewish Hospital drew unequivocal denials from KentuckyOne. The hospital system and its partner, the University of Lousiville, finally broke silence and admitted that the couple had gotten off to an unanticipated (but perhaps not unpredictable) rocky start to their marriage. An additional report that Catholic Health Initiatives was talking with Tenet Healthcare has not been denied publicly to my knowledge, as of course it could not be. The fact is that Tenet is now fully engaged in providing services at Jewish Hospital. How much of the Jewish Hospital operation has been transferred to Tenet, and the ultimate outcome of the involvement of yet another out-of-state-corporation in Louisville remains to be seen.

There were of course any number of reasons CHI might wish to talk to Tenet. For one thing, since 2012, the two large corporations have been partners in jointly owned Conifer Health Solutions. Conifer specializes in “revenue-cycle” services for hospitals, including many, if not most of CHI’s. To my non-business mind, such services involve getting every last nickel that’s due out of patient billings. Since KentuckyOne Health has been losing money for CHI, it is not surprising that calls for outside help may well have been suggested or demanded. Continue reading

UofL Sends Its Recent Audit and Report Card to the Public.

What would you say to your kid if they brought this home?

I received a letter from UofL President James Ramsey this week along with a copy of the “almost an audit” of the University’s financial operations from Strothman and Company that I wrote about earlier. The package was not sent to me as a journalist, but was presumably sent to everyone connected with the University such as people like me who contribute to its fund-raising initiatives. This Strothman “Report” is identical to the one released to the UofL Board of Trustees and the press, and suggests to me that it was intentionally written for a technically less sophisticated audience thus reinforcing my belief that the comprehensive report is still being kept secret– perhaps even from the Trustees.

The mailing includes a cover letter and report card from of this month’s Board of Trustees evaluation said to reaffirm that UofL is continuing on its “amazing trajectory.” However, the bulk of Dr. Ramsey’s letter deals directly with the problem of “a few employees who are dishonest.” While he expresses the University’s “regret” over the violation of the public trust, he did not go so far as to apologize. Perhaps that would have been too much to ask.

Audit Committee of the Board.
The recommendations, but perhaps not the findings by Strothman, were presented to the Board of Trustees Audit Committee in early July with an indication from the President and his staff that they concurred with almost all the recommendations. I do not know just what the Audit Committee was shown, or what the full Board was allowed to see. (Why would the Board be denied access to such things?) I do not know what, if any, action the Board took on the report. There are however reports that Board members were allowed to see some different documents for short periods of time before they were confiscated. Such allegations should not go uncorrected. If the UofL Board of Trustees allowed themselves to be treated in such a way, I suggest they are not doing their jobs for us.

Report Card.
The package included a one page “report card” that has been used for quite a while as a measure of the University’s progress toward its goals. This report card is also used in the evaluation of the President. The present table lists 14 separate items selected from a longer list of which I no longer have a copy. We must therefore assume there was some selection process used to decide which items to show publicly. (Statistically, we would call that a bias.) The report card items were divided into five categories. Continue reading

The Audit That Might Have Been at the University of Louisville.

Last September, following a string of multimillion dollar embezzlements at the University of Louisville, and in the midst of ongoing concerns about the health and even the integrity of the its financial operations, the University retained Strothman and Company of Louisville for an independent outside audit. Strothman has relevant experience auditing large public institutions and has a member of the UofL Board of Trustees as a client. It is more than competent to perform an in-depth financial or management audit. The cover sheet for the Request for Proposal required that the auditors would, by March 31, 2014, perform:

• A special examination of the processes and procedures of internal audit,
• survey banking to identify UofL accounts,
• evaluate internal controls related to signature authority and vendor legitimacy,
• and examine the financial controls for faculty professional practice.

While this certainly was a reasonable business decision given the obvious system breakdowns and criticism from the community, I suspect the University felt compelled to offer at least some measure of accountability much as it did when it agreed to an audit of its handling of the QCCT fund for indigent care in early 2012. There is always some risk that an external review will turn up shortcomings, or worse. The QCCT review was not at all flattering and for whatever reason, that funding mechanism seems to be being phased out. A subsequent audit of the University’s involvement in Passport, the Medicaid managed care plan, revealed financial manipulations that were frankly illegal. High-ranking officers lost their jobs. A source of unrestricted money for the school dried up. In outside reviews of its academic affairs as evidenced by rejection of yet another application for a Phi Beta Kappa chapter, and placement of its entire Medical School and its Continuing Medical Education program on probation, UofL has not been faring very well either. Little wonder the University spends most of its promotional effort on its sports programs– Beer and Circus instead of Books and Brains. I suggest that identifying problems is not something to be afraid of. It is how the institution deals with unflattering appraisals or criticism that defines both its credibility and its strength. In my opinion, UofL’s reflexive posture of stonewalling the public is hurting it much more than revelation of its failings. This has to stop if the community is to gain the confidence needed for it to provide needed support. Continue reading

Medicare Payments to Oncologists in Kentucky.

Since my initial exploration of Medicare’s Physician Payment Database, I have not done much with it. The expectation that the information would be of great interest to many has been validated, and the utility and shortcomings of the data better understood. The potential is great that these data can be used to improve the quality, affordability, and availability of medical care. As might have been predicted however, a great deal of attention has been focused on identifying medical malfeasance and fraud.

I have always been of the opinion that examination of outliers in big data sets like this one is extremely valuable in health policy research. This is especially true in American medicine where there is such great variation both in the frequency in which various medical services are provided, and the amount of money charged. Looking at outliers does not automatically assume that something inappropriate is going on. A place or provider where a large number of things are being done may be a center of recognized excellence. On the other hand, and as we have seen in this series of articles, such “hotspots” of activity may represent inappropriate, abusive, or even illegal medical practice. I believe that large utilization data sets like this one beg us to ask questions about how to use our healthcare resources fairly, efficiently, and most of all effectively. A strategy I recommend is to start by looking more closely at the top 10 and the bottom 10 on any such list. Is that entry there for the best of reasons to be emulated, or for reasons of less value to be corrected? When you are done with the top ten, go on to the next, and so on.

Data is non judgmental, but is it easier to find the bad stuff?
With this as my working background, a series of reports about convictions and settlements related to two oncology practices caught my eye. One practice in Somerset was inappropriately buying non-FDA approved chemotherapy drugs manufactured in Third World countries and selling them here at inflated American prices. In a second practice in Elizabethtown, two physicians were markedly prolonging the duration of chemotherapy infusions in order to charge Medicare at a higher rate. The defensive rationale offered for this unique approach was in my opinion indefensible and I have not yet seen any other medical authority venture a different opinion. Presumably, these practices had been going on for some time, wasting money and exposing patients to harm. I wondered how the named providers in these settlements would have appeared in the 2012 Medicare Provider Payment Database. In fact were at or near the top end of all the charge and payment categories. Continue reading

Conflicts of Interest in Continuing Medical Education Yield Probation at UofL.

On May 2, 2014 Laura Ungar of the Courier-Journal reported that the Accreditation Council for Continuing Medical Education (ACCME) had placed the University of Louisville Program of Continuing Medical Education (CME) on probation. Given that UofL’s School of Medicine itself had just been placed on probation by other accreditors, this second failure of external review is yet another indicator that something is very wrong at our academic medical center.

UofL’s CME program oversees the integrity and scientific merit of postgraduate medical education offerings attended by medical students, interns, residents, faculty, community physicians, and other healthcare professionals. As a nationally accredited program, UofL also sponsors and certifies CME programs in other states, internationally, and on the Internet. Since the majority of CME is now paid for by pharmaceutical and medical device companies, the need for unbiased information is greater than ever. It is in this arena of avoiding commercial intrusion on its academic affairs that UofL stumbled.

What happened?
The specific event reported to have led to this action was the discovery that “a physician employed by a pharmaceutical company taught at one all-day course in Phoenix.” However, representing the University, Dr. W. Daniel Cogan, Assistant Dean for Continuing Medical Education and Professional Development would not name the drug company, the employee, or the partner organization sponsoring the untitled course. “Our program is clean except we had that one error,” he said. “It’s a high-quality CME program.”

The big Lebowski would not let this stand!
A refusal to disclose information that is already in the public domain was disappointing to me, but hardly a surprise given the University’s reflex instinct to avoid disclosure of information incompatible with its public relations spins. When will it learn that the enduring damage from bad news comes from attempts to avoid disclosure, or in covering-up? Refusal to disclose the details surrounding such a core failing of University responsibility drove me to make a Freedom of Information Request to UofL for relevant documents. It took a while and I did not get everything I asked for. Nonetheless, I am not comfortable with what I found, nor in the state of the national enterprise the provides the bulk of medical education to trainees and practicing physicians. In my opinion, the pharmaceutical, medical device, and related industries have captured the mechanism of continuing medical education and have done so with at least the cooperation of institutions of medical learning. Continue reading

Prohibition of Same-Sex Marriage in Kentucky Declared Unconstitutional.

The other shoe has fallen in a pair of court challenges from Louisville seeking to overturn Kentucky’s statute and constitutional amendment that prohibit same sex marriages or the recognition of the same as unconstitutional. The case began as Bourke v. Beshear demanding that Kentucky government and businesses apply law and regulation pertaining to marriage equally to legally married couples regardless of gender-mix. Judge John G. Heyburn, II found no fault with the Plaintiffs’ claim and ruled that Kentucky law’s on recognition of otherwise legal same-sex marriages to be unconstitutional. Kentucky’s Attorney General Jack Conway agreed and declined to appeal Judge Heyburn’s opinion which was ultimately stayed pending appeal and review by higher courts.

Seeking to rip out both vine and root, and ignoring the advice of other advocates who argued that the time was too soon to take on the basic issue of the prohibition of same-sex marriage in Kentucky proper, additional plaintiffs jointed the Bourke case which appropriately is now renamed Love v. Beshear. On July 1, 2014, Judge Heyburn found that Kentucky’s prohibition of in-state same sex marriages is unconstitutional under the equal protection clause. That order was also stayed pending expected review by the Federal Sixth Circuit Court of appeals in Cincinnati this August.

The finding.
IT IS HEREBY ORDERED THAT to the extent Ky. Rev. Stat. §§ 402.005 and .020(1)(d) and Section 233A of the Kentucky Constitution deny same-sex couples the right to marry in Kentucky, they violate the Equal Protection Clause of the Fourteenth Amendment to the United States Constitution, and they are void and unenforceable. Continue reading

Catholic Health Initiatives Reports Increasing Financial Losses in Kentucky.

Last Thursday, Chris Otts of WDRB News may have been the first to report on Catholic Health Initiatives’ (CHI) most recent quarterly report to its creditors covering the 90 days ending March 31, 2014. Meant to be read in conjunction with last November’s audited annual report, the current unaudited update covers the first full year that CHI has controlled “substantially all of UMCs operations” at University of Louisville Hospital (ULH). The news report focused on the fact that KentuckyOne Health, the manager of CHI’s multiple hospital-related operations in Kentucky, had lost an additional $134 million on its “faith-based” hospital operations over that 90-day period. This stunning loss comes on the heels of an earlier report that KentuckyOne had lost $100 million in the six months ending December 31, 2013.

More than just financial data is provided.
The full report is in the public domain. My reading confirmed what was reported by others. However, I was struck more by other tidbits of information that confirm or add to our knowledge of what is happening behind the surgical drapes hung to to keep the rest of us from assessing the health of this hospital system of which a public asset is part. Continue reading