Potpourri of Health Policy Issues in June.

My cup runneth over with potential issues to explore.

June has been a busy month both locally and nationally insofar as things I like to write about. The shame-on-me is that I have not carved out enough time to do so!  In part I am still picking up the pieces after my early spring travels. Exploring how to unpack and deal with the new Medicare prescription drug data base also took a lot of time.  The truth is that I am a slow writer handicapped by a default and probably over-wordy professorial style.  I haven’t even been able to update the Institute’s Facebook and Twitter pages!  What follows is a list of things that occured during the month that I wanted to write about and hope to do so in more detail later.  These are not necessarily in chronological order or of importance.

The Supremes Rock & Rule!
We were presented with two back-to-back major decisions by the U.S. Supreme Court. The first, King v. Burwell, allows federal subsidies of health insurance premiums for low income individuals and their families to continue even if their insurance was purchased in states that chose to allow the federal government to operate their health insurance exchanges.  The lawsuit brought by Obama/Obamacare-haters to limit premium support to insured individuals in states like Kentucky that chose to operate their own exchanges would have essentially gutted the Affordable Care Act (ACA) and tossed millions back into the uninsured category. For the time being, Obamacare stands intact for at least the next year and a half, despite promises by opponents to throw up additional challenges. All our legislators should be working together to deal with a major remaining deficiency of the ACA.  The Act has been very successful in decreasing the number of uninsured people, but it makes little headway against the exploding costs of unnecessary, marginally effective, or for that matter even necessary medical care.  Continuing to forbid the federal government to negotiate over the prices of drugs is a case in point. Subsidies were deemed necessary for a reason!

Love Wins! (The eponymous lawsuit and commitment both.)
The second Supreme Court decision in Obergefell v. Hodges, announced only last Friday, not only requires all states to recognize legal same-sex marriages performed in other states, but now requires all states to provide civil marriage licenses of their own to same-sex marriage applicants!  The practical result of this decision is that in all state and federal law, the benefits and responsibilities of marriages are identical, regardless of the sex of the marriage partners. Arguments that marriages are essential to promote the breeding of human livestock, or are ordained and allowable only for people who believe in God were dismissed.

True, true, and related.
The two decisions mentioned above are not entirely independent of each other.  It has recently been demonstrated that after same-sex marriage became legal in New York, that a substantial number of the partners and their children rose from the ranks of the medically uninsured.  This occurs chiefly because employers may no longer discriminate and must offer identical individual and family benefits to all their employees.  It will be interesting to see how this plays out in Kentucky where in the past such differential treatment of employee families was a fact of life.  Additionally for the healthcare industry, the oft-complained-of situation where a same-sex spouse is excluded from communication or denied other privileges enjoyed by a married partner of a patient should entirely disappear. Should examples of the disparities described above continue to occur, I hope someone will contact me.

Sad commentary to the above.
The prominent loss of respectful good will among elected officials of the two main political parties appears to have bled over to the Supreme Court. In my opinion, the language of the dissents in the cases above, especially that of Justice Scalia, moves from disagreement through snarky to frankly nasty. Parallel polarization is probably to be expected given the intensely political process used to nominate and approve the Court’s justices.  Public confidence in the decisions of the Court has become contaminated by our appetite for the blood sport of politics.

Prescription drug abuse in Southern Indiana.
The Courier-Journal reported arrests of out-of-state unauthorized traveling salespeople of the restricted narcotic painkiller Opana— a drug of choice in the troubled communities of Scott County and southern Indiana where illegal drug use, HIV, and hepatitis-C have become epidemic. Opana and Opana ER (Extended Release) are brand names of oxymorphone HCL. The arrest stimulated me to look in the Part-D Medicare prescription drug database to see where Opana was being prescribed locally to Medicare beneficiaries and perhaps through them to the profitable secondary market.

The results were both of interest and potentially troubling. Of all the 72 cities and towns of Indiana in which Opana was prescribed in 2013, only in Fort Wayne and Indianapolis were more prescriptions written than in New Albany or Seymour which were numbers 3 and 4 in the list.  Jeffersonville was number 8.  It is clear that there are plenty of Opana ER pills available within the state. (Table of top 30 cities here.)

Some other stunning outliers are present.  For example, among the 206 Indiana providers who prescribe Opana ER to more than 10 patients, the average number of prescriptions written per provider is 35 and the median is only 20.  Striking then is the observation that 15 providers prescribed more than 100 times each– the highest being 265 prescriptions by a single provider.  I continue to be perplexed by the overall observation that nurse practitioners and physician assistants as groups prescribe opioids so extensively. In Indiana, the category of provider that prescribes the most Opana ER is Nurse Practitioner.  (Table of prescriptions by provider type here.)  Of course I do not at this time conclude that anything improper is going on, but I do think that some entity needs to take a look. “Pill mills” have been known to use the provider numbers of nurses in the past.  If requested, I will present the underlying data for your review and further analysis.

Medicare Fraud and Medical Kickbacks.
On June 18 and with considerable fanfare, the FBI, other law enforcement officials, and Health and Human Services announced the largest ever coordinated crackdown against Medicare fraud and the the first major action focusing on Medicare Part-D drug fraud. It involves 243 people (of which 46 were licensed healthcare professionals) and $712 million. Andrew Wolfson of the CJ pointed out that 12 of those charged with $8 million worth of fraud were in the Western Federal Court District of Kentucky including schemes involving opioid narcotics.

In an apparently separate action, the New York Times (June 25) reported that a Connecticut nurse pleaded guilty to receiving $83,000 as a kickback for promoting the use of Subsys, a brand name for the powerful opioid-analgesic fentanyl.  This was not the first time that Insys Therapeutics has been looked at for improper marketing of its product and no doubt will be under the microscope in the future. The nurse may have come to the attention of law enforcement because she was found to a high prescriber of Subsys although this probably happened before the Part-D database was released to the public.

I looked at the current database reflecting prescriptions to Medicare patients in 2013. The nurse in question was only ranked #10 in the list of 69 providers nationally who prescribed Subsys to more than 10 patients.  She wrote 69 prescriptions for 20 patients for a total of $239,224. Of the 9 providers prescribing Subsys more often, two were physician assistants. Our Connecticut nurse was a piker however compared to the top physician who wrote 1161 prescriptions for 258 patients for a total of $6,443,778 worth of drug.  Notice the large amount of money in play for brand names of this drug, and Subsys is only the third most expensive per presctiption in the list of 10 different fentanyl preparations!  I am relatively gratified to note that only a single Kentucky provider prescribed Subsys and only 17 times to more than 10 individual patients at that.  There were none in Indiana!

I predict that the publication of payment amounts to hospitals and other providers for services to Medicare patients is going to identify large numbers of other fraudulent activities and will provide the impetus for earth-shaking changes in the way healthcare is financed and indeed how healthcare itself is delivered. While there are better medical reasons to move to a single payer or similar model, having a comprehensive payment database will help weed out fraud, misuse, and waste in our extraordinarily expensive system.  I invite my readers to look through the tables I present in these pages or the main CMS files themselves to help our system evolve for the better.  In particular, and in the spirit of a non-judgmental examination of the payment numbers, I invite anyone to point out examples of how this important information can identify best practices.  Otherwise CMS has done little more than provide a tool for law enforcement.

UofL Board of Trustees.
The Board met earlier in the month.  There were none of the blowups that characterized May’s meeting.  The bulk of the meeting was filled with tours, in which I participated, of several UofL and KentuckyOne Health facilities.  At the limited formal business meetings, the main and final action-item was the official raising of student tuition for 2015-16.  The Trustees were addressed by Catholic Health Initiatives CEO, Kevin E. Lofton.  In his refreshingly candid presentation, Mr. Lofton confirmed some of the difficulties attendant to the working integration of the two partner institutions about which I and others have been writing.  Of note, included in future plans include a new “east-end ambulatory center with potential small inpatient program.”  It appeared to me that an important goal of the day’s sessions was to attempt to convince the Trustees of the importance of maintaining the UofL/KentuckyOne Health partnership.  Conversely, in my opinion, several presenters went out of their way to assign blame for University problems to Norton Healthcare. I hope to say more about this carefully orchestrated day’s activities and Mr. Lofton’s presentation later.

New UofL Trustees appointed.
As I write this, the Governor’s office has announced two new UofL Board appointments and the reappointment of a third. How these appointments effect the direction of Board action remains to be seen.  No doubt the Governor has taken current events into consideration in making his choices.

State Auditor to examine UofL Foundation and board governance.
Based on requests from “dozens of business and community leaders” and at least one UofL Trustee, the office of state Auditor Adam Edelen will examine elements of governance related to the University of Louisville and at least one of its associated foundations, the UofL Foundation. In my opinion, such an outside examination that is truly independent is long overdue.  The University has brought this upon itself with its secrecy and arrogant posture of non-accountability. I need to gather more facts, but it appears that this will be a management audit, and not the follow-the-money audit that I think is absolutely necessary to restore the public’s confidence that has been unnecessarily squandered by this state educational institution.

Is the QCCT fund defunct, or just been diverted to other uses?
In reviewing Mayor Greg Fisher’s proposed Louisville Metro Budget for 2015-2016, I noticed that the amount of the city contribution for the Quality Charity Care Trust was zeroed out. The QCCT has provided a dependable amount of state and city funding–matched by Medicaid– to University Hospital in exchange for a promise to provide medical care to all indigent Jefferson County patients and a limited number of out-of-county patients. It was anticipated that with the passage of the ACA, that the number of uninsured patients would decrease and indeed that has happened. I have been informed that University Hospital is having a record low number of uninsured patients and a corresponding large increase in revenues.  Nonetheless, a prior agreement had stipulated that at least some contribution to the QCCT by the city would occur in this last year of the state’s budget biennium.

I have argued that the QCCT model of public funding for indigent and financially needy patients had outlived its time, and indeed is contrary to the interest of both the public and individual patients alike. Wondering what was going on, I called the Mayor’s office where a spokesperson offered that no funding was necessary this year because University Hospital had not even used its allotment from last year, but that the Trust itself was being kept open at the request of the University so that existing funds could be expended. I have no idea what the state is going to do.

Because I think the matter of how we as a public finance and provide medical care to the most vulnerable among is important and tells a lot about us as a community, I have begun to look into the matter in more detail. I have concluded so far that the whole story is yet to be told! Indeed, the records of the Trust that used to be kept on the UofL website have not been updated in over a year– this despite a scolding by the state auditor in 2012. In response to initial requests to the QCCT corporation, I received a copy of most recent contract dated November, 2014.  There have been some significant changes since the last contract in November 2012 including a promise by the city to contribute $3 million for FY 2015-16. Perhaps most interesting are clauses specifying that the University of Louisville itself will for the first time make a contribution of $5 million to the fund for FY 2014-15 and up to $5 million for FY 2015-16.  I must assume that the University Contribution will be put up for a Federal Medicaid match as an Internal Governmental Transfer as has been the practice of the city and state in the past.  Additionally, beginning with the contract of 2012, the new faculty private practice building is designated as an eligible recipient of QCCT money for hospital services with implications for enhanced Medicare payments.

Of note, the current signatories to the QCCT contract are still the Commonwealth, the City, the University of Louisville, and University Medical Center, Inc.– the legacy manager of the hospital that now is said to manage women’s and obstetric services within the University Hospital building.  It is curious that KentuckyOne Health, the manager of the University of Louisville Hospital and provider of the vast bulk of indigent care at University Hospital, is not a signatory to the QCCT and thus makes no promise to provide all necessary indigent care.  I don’t understand what is going on, but the current QCCT contract only adds to the mockery of the supposed clinical separation of KentuckyOne and the Center for Women and Infants. They are separate clinical entities by faith alone.

I am still gathering information, but I have to ask is what is going on here?  Whether or not matching federal dollars are involved, how is the already transferred money and future contributions being spent?  Is the money being used for indigent patient care that we are told is no longer needed? Is even more money being bled off the hospital for commercial research or in pursuit of the stated UofL goal of harvesting more healthcare money for general University purposes. Given the inclusion of the new faculty practice building as an entity eligible to receive QCCT finding, are QCCT funds being used to bail out faculty private practices still reeling from having to pay reparations for University misuse of Passport Medicaid Managed Care money? Surely the public is entitled to know. In any event it is already clear that the QCCT contract is already null and void on the face of it.  I will post relevant documents as I receive them. [All previous contracts available here.] Further information as I learn it.

Concern over ethics of KentuckyOne marketing of its Cyberknife.
Andrew Wolfson reported (June 17) that the Ethics Committee of University of Louisville Hospital wrote to its KentuckyOne administration expressing its concern that a large banner on the walkway across Jackson St. exhorting patients to “Fight Cancer with 5 or Fewer Treatments” was misleading and requested that it be removed.  Reporter Wolfson collected statements from respected outside experts in both medical ethics and radiation therapy that agreed with the Committee.  The Hospital declined to remove the promotion.

This is in my opinion an exceedingly important matter.  It was the Hospital Ethics Committee and not the University Research Committee that stood up to KentuckyOne when the hospital requested that existing standard language in patient informed-consent forms for clinical research that mentioned contraception and termination of pregnancy be removed. For that and other reasons I have great respect for the hospital Ethics Committee. I was troubled too when I saw the Cyberknife advertisement.

There are many facets of this story that deserve public airing and discussion.  Where is the line past which medical marketing should not cross?  In matters of public/private partnerships such as the Cyberknife, what degree of even potential conflict of interest should be disclosed publicly?  To my knowledge, and despite my attempts to find out, the initial and current investors in the Cyberknife have not been fully disclosed. In my opinion, especially given the discrepancy between declarations by the the hospital and clinical department offering the Cyberknife service, and the comments of credible outside observers, KentuckyOne must fully disclose the ownership history of this complicated financial entity in order to rapidly dispel accumulating clouds of concern. Surely both the public and potential patients must not be allowed to wonder even for a moment or in error that clinical recommendations are being colored by pressures from outside investors.

Also in order is comparative information about the composition, practices, and independence of our local hospitals’ ethics committees. What should such committees consider?  Are they or should they be limited in any way about what medical issues they may consider?  Who do they report to?  What entity has final say or veto over their decisions?  What part of the committee’s work, if any, should be influenced by specific religious doctrine?  Given that all our local hospitals are part of hospital systems, what is or should be the role or permissible influence of corporate management on individual hospitals?   I plan to elaborate on the known history of the Cyberknife at UofL and the important issues raised in a future article.

Not short.
Well, I hit 3000 words again, but at least the individual topics addressed were several. Let me know which you think among these I should address in greater detail sooner, or for that matter, what have I left out.  Help me correct any errors.

Peter Hasselbacher, MD
President, KHPI
Emeritus Professor of Medicine, UofL
June 28, 2015

4 thoughts on “Potpourri of Health Policy Issues in June.”

  1. Plenty of Opana to go around!
    Laura Ungar had an article in today’s papers highlighting recognition that the epidemic of infectious complications and other ravages of prescription drug and heroin abuse are not limited to Scott County, Indiana but are present in neighboring Clark County. Is it a coincidence then that New Albany and Jeffersonville are hot spots for the prescription of Opana, a regional abused drug of choice? I think not. There is of course no reason not to believe the same things are happening in next-door, big-city Louisville where it is easier to get lost or be ignored. I will extend the tables published above that tally Opana prescriptions to Indiana’s Medicare patients to include Kentucky’s cities and providers. We should not be surprised if we find that a very few providers do the bulk of prescribing of this particular drug.

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