Legal Fundamentals of Surrogate Decision Making

My article, "Legal Fundamentals of Surrogate Decision Making" has just been published in Chest.  Here is the abstract:





The four previous articles in this series have traced the history of patient autonomy and have identified its ethical and legal foundations. Patient autonomy is highly valued in the United States to the extent that the patient does not lose the right of self-determination when he or she loses the capacity to make health-care decisions for him or herself. The law has devised several tools to promote “prospective autonomy.” One mechanism is the instructional advance directive or living will. But most of us do not write such directives. Another mechanism is the proxy directive or durable power of attorney for health care, designating another person, a surrogate, to direct the course of our medical treatment upon our incapacity. But most of us do not do that either. Therefore, the most common mechanism by which our prospective autonomy is protected and promoted is through the informal selection of surrogates based on statutory priority lists. These “default” surrogates are the most numerous type of surrogate. This article explains the importance and legal fundamentals of surrogate decision making. It first describes five basic types of surrogates. The article then looks at the role of these surrogates and how they are supposed to make decisions on the patient’s behalf. Unfortunately, surrogate performance is often mediocre or poor. There are significant and persistent obstacles to good surrogate decision making. After explaining these problems, the article concludes by identifying several solutions.



Fist Fight and Love Triangle In Pennsylvania Costs One CEO His Job -


A job paying $4.5 million a year is not easy to come by, at least in my area of the world it’s not.  He used to have clout and now with this all over the media, I guess time will tell imageif it stays or goes away.  This is bizarre as his mistress as she is called moved out from her home with her husband, and then the former CEO, Melani hired a private detective to follow her.  Something must have been cooking as he showed up and the husband was there and it sounds like that’s what erupted into a fist fight.  Highmark as a company also has this battle in place with UMPC. 

Hospitals and Insurance Company Competing for Patients In Pittsburgh–Contracts In Question


From the website:


“Our history of helping families and companies with their health insurance needs dates to the 1930s, when our predecessor companies were established to helpimage Pennsylvania's residents pay for health care.

Highmark was created in 1996 by the consolidation of two Pennsylvania licensees of the Blue Cross and Blue Shield Association — Pennsylvania Blue Shield (now Highmark Blue Shield) and Blue Cross of Western Pennsylvania (now Highmark Blue Cross Blue Shield). We are now one of the largest health insurers in the United States.”

In addition Highmark and the Blues Group, which was their origin also bought NaviNet which is a Health IT technology company that connects medical records. So there was a lot going on for sure business wise and otherwise.  BD 

Blue Cross/Blue Shield Insurers and Highmark Acquire NaviNet Transactional Portal And Medical Records Vendor–Subsidiary Watch

Video below and is appears they both the husband and the doctor had bleeding faces and the board of directors held a meeting hours after the assault.  BD



He held the CEO post of one of the largest health care providers in PA and now he is facing serious allegations following a sex scandal.
Here in Central PA, thousands are employed by Highmark and shocked to hear the news that higher-ups fired CEO Doctor Kenneth Melani Sunday morning.

Dr. Ken Melani is out as CEO of Highmark, a post that paid $4.5 million a year and gave him serious clout in the industry.
Melani is accused of getting into a fist fight in a neighborhood near Pittsburgh with the husband of Highmark employee Melanie Myler who he was allegedly having an affair with.
“The reports are scandalous in nature, it isn’t flattering,” stated attorney Robert del Greco.
Melani’s attorney went onto say they don’t know if he was fired under moral grounds or something else entirely.



http://www.whptv.com/news/local/story/Highmark-CEO-fired-over-love-triangle-brawl/ki_NJGqU1EKAeKFIwW16sg.cspx

Neupro Patch Gets FDA Approval for Advanced Stage Idiopathic Parkinson’s Disease and Restless Leg Syndrome

The patch is worn for a day and imagecontains a sulfite, sodium metabisulfite that some are allergic to and you have to watch for a few other drug interactions with anything that causes drowsiness and there’s a side effect of hallucinations and that side effect is higher with those who have Parkinson’s disease. 

Another side effect is an urge to behave unusually, urges to gamble or increased sexual urges.  This is right off the website with the warnings.  The drug is said to stimulate dopamine receptors that regulate movements.  BD


BRUSSELS & ATLANTA--(EON: Enhanced Online News)--UCB announced today that the U.S. Food and Drug Administration (FDA) approved Neupro® (Rotigotine Transdermal System) for the treatment of the signs and symptoms of advanced stage idiopathic Parkinson’s disease (PD) and as a treatment for moderate-to-severe primary Restless Legs Syndrome (RLS). Neupro® was previously approved by the FDA for the signs and symptoms of early stage idiopathic PD. Neupro® is a dopamine agonist patch that provides continuous drug delivery for patients with PD and RLS. The FDA has also approved UCB’s new formulation of Neupro®.

“RLS can be a serious condition with symptoms that affect patients during the day as well as at night; and Parkinson’s disease symptoms can have a broad impact on patients. Neupro® provides a novel way of treating RLS and PD through continuous transdermal dopaminergic delivery. It can help patients manage the unpredictable nature of these chronic conditions,” said William Ondo, M.D., Professor, Department of Neurology, University of Texas Health Science Center at Houston.

http://eon.businesswire.com/news/eon/20120402006986/en/Neupro%C2%AE-Approved-U.S.-FDA-Parkinson%E2%80%99s-Disease-Restless?utm_source=dlvr.it&utm_medium=twitter

Express Scripts and Medco Get Federal Approval To Merger Valued at $29 Billion - Is It All About Data to sell for Bigger Profits?

This means more mail order prescriptions on the way

eventually as almost all health plans today have one.  I wonder how this affects chain pharmacies like Walgreens who are still disputing contract amounts with Express Scripts.

  Blue Cross members can’t get prescriptions there so now does it all switch over to Medco? 

Express Scripts to buy Medco for $29 Billion–Medco 2nd Quarter Profits Were Down 4% And the Profit Algorithms Once Again Are Hard at Work To Control Costs via Acquisition
 
The initial announcement of Express Scripts was announced in July of 2011.  When you add in Caremark as the other large PBM that’s like a huge amount of the mail in pharma business in the US.



Walgreen Dumps Express Scripts Pharmacy Benefit Manager–Contract Dispute With Reimbursement to Retail Chain Too Low


Now let’s look at something else going on in the drug business with FICO selling software to companies such as PBM managers and now it gets interesting with analytics that are using mismatched data that has been spun and marketed, with FICO claiming they can predict medication adherence.  How man PBMs are buying this and what will it do for access for patients?  This is just one more example on how marketing today puts a wild spin on things and it goes on behind the scenes and denies due to parameters not being met, whatever they are.



FICO Analytics Press Release Marketing Credit Scoring Algorithms to Predict Medication Adherence–Update (Opinion)

One thing to keep in mind today is that with mergers and acquisitions, along comes aggregation of data for analytics and to sell for a profit and PBMs do that big time and companies are making billions selling data so again keep that thought and the acquisitions of today might look a little different to you as if Walgreens in the SEC statement in 2010 made short of $800 million selling data, just think what these two conglomerates make, it makes my head spin and wonder if selling prescriptions is merely the gateway to profits on selling data.  I’m not the first one to say this and I won’t be the last.  If you know math and see that Walgreens number, you can’t over look it.  BD

 



Despite potential antitrust concerns and vocal opposition by some lawmakers and consumer groups, Express Scripts and Medco Health Solutions, two of the nation’s largest pharmacy benefit managers, said Monday that federal regulators had approved their $29 billion merger.

The decision, by the Federal Trade Commission, to let the merger proceed was not unanimous, indicating conflicting views among the agency’s top regulators over whether to challenge — or impose limitations on — the combined company. After eight months of review, the F.T.C. commissioners voted 3-to-1 to close the agency’s investigation.

The acquisition of Medco by Express Scripts, based in St. Louis, creates what is now the industry’s largest player, with $116 billion in 2011 revenue. CVS Caremark, itself the product of a merger between a large drugstore chain and a benefit manager, is now the second-largest competitor with $107 billion in revenues.

Pharmacy benefit managers, known as P.B.M.’s, manage prescription drug plans for employers and insurers. They serve as middlemen between the drug companies and the payers.

Two groups, which represent community pharmacists and chain drugstores that have strenuously objected to the combination, filed a lawsuit last week seeking to block the merger. The National Community Pharmacists Association and the National Association of Chain Drug Stores, which see the combination as problematic for pharmacies, said they planned to pursue their litigation.

http://www.nytimes.com/2012/04/03/business/ftc-approves-merger-of-express-scripts-and-medco.html?_r=1&smid=tw-nytimeshealth&seid=auto

Over Diagnosing for Breast Cancer? Report Suggests Some Treatments Were Not Needed

This is one that I know about through my mother as we had this happen.  It turned out she did not have breast cancer and a “mass” was found.  I’ll make this brief but she imagewas over-diagnosed when the x-ray was blown up to further investigate.  That lead to a biopsy which was also messed up and if she would have gone for treatment for this tiny miniscule mass they found with radiation, she may not be here today at age 87 and this was about 3 years ago when all this occurred. 

Upon consulting with a veteran surgeon who went over everything in detail he said yes she has a mass but it was not cancer and he has done a ton of surgeries for breast cancers so he was experienced. 

He gave her the choice though of having it removed or not and when we discussed it we decided against it and keep in mind too this was at a time when propofol was hard to get all the time and he informed her he would need a “special anesthesiologist” to work with another drug and keep her “under” time down to an absolute minimum as even he knew after seeing her chart that her health was a bit on the fragile side with a long history of blood pressure, heart problems and diabetes. 

After all was said and done the insurance company went back to investigate the original oncologist and radiologist. 


The radiologist had called my mother about her experience with the oncologist as well and about the office since they were new partners.  The radiologist left and went elsewhere and the insurance company ended up fining the oncologist who seemed to be more interested in making my mother a case study than treating her cancer.  This is not representative of most doctors thank goodness and the pressure to sign up after the consult from the messed up biopsy was horrendous.  She could not get out the door without making her appointment for the treatment with the brand new Mammosite machine they had just purchased. 

FDA Clears Hologic's MammoSite(R) Multi Lumen Radiation Therapy – Breast Cancer


She made the appointment, went home and then cancelled the next day and the girl in the office was scared half to death over her job as she was evaluated on her patients relations and bookings for treatments for productivity.  So much for pay for performance at this level I said. 
 

So in summary screenings are still good in my opinion; however involving the patient here as we were with my mother lead to a very different outcome and results from the moment that she was told she had cancer.  Of course she signed all the releases for the doctors stating that she was declining radiation treatment.  After our experience with weighing everything and especially after the consult with the surgeon we felt we made the right decision. 

Again this was a very tiny spot and the following year her mammogram was clear!  But wait, 2 years later next mammogram and they again find a tiny spot and again blew it up to investigate and again I’m not picking apart the procedure or doctors at all, but, it was good to have case history and see almost the exact same thing as what set off whistles and bells 3 years prior and again we stopped there once more and opted out for surgery.  She’s still here today and again I can’t emphasize enough that each case is its own and we were and are lucky but I also understand that this is just her case and everyone needs to get all the information they can and make their own decisions.   BD

(Reuters Health) - A new report suggests that when a breast cancer screening program was rolled out in Norway, up to 10 women were diagnosed and treated for cancer unnecessarily for every breast cancer death that was prevented.

That’s because when doctors screen for cancer in women who don’t have symptoms, it’s impossible for them to tell whether a tumor picked up by mammography will grow quickly into advanced cancer or will only progress slowly or not at all, said lead author Dr. Mette Kalager.


You have to really consider the benefit and the harm against each other, and really think through: what is my risk of dying from breast cancer, and what is my risk of being overdiagnosed?" she said.

http://www.reuters.com/article/2012/04/02/us-breast-cancer-idUSBRE83112U20120402

Oracle Buys Cloud Based Clinical Trial Application Company–ClearTrial

It was not too long ago that Oracle Larry Ellison received an award for his contributions

to Health IT from the NIH.  We see the move with analytics all over healthcare today so this makes sense for Oracle to be in this business.

image

Oracle and Clear Trial will continue to operate as separate companies and biopharmaceutical, device and diagnostic companies are under more pressure than ever today to keep things in a budget for sure.  BD

 

Larry Ellison Announced As Distinguished Medical Informatics Awardee for His Contributions to Health IT and the Ellison Foundation From the Friends of the National Library of Medicine (NIH)

Summary: Oracle plans to combine its analytics resources to ClearTrial’s imagecloud-based clinical trial operations applications to produce a single, cheaper option for biopharmaceutical and medical device companies.

Oracle is beefing up its health sciences suite (and its cloud-based solutions portfolio) with the acquisition of ClearTrial.

ClearTrial is a provider of cloud-based clinical trial operations applications intended to facilitate the planning, sourcing, and tracking of clinical projects while ensuring a more accurate and faster financial performance. Its customer base ranges from emerging companies to top-tier biopharmaceutical companies

.

http://www.zdnet.com/blog/btl/oracle-acquires-cloud-based-clinical-apps-provider-cleartrial/72748

Study Suggests that Pay for Performance Incentives for Hospitals Is Not Leading to Better Patient Outcomes

Back in January of 2011 we had another study saying the same thing so we can add one more bit of information to the theories that pay for performance are worthwhile?



Does this further suggest that insurers all over are not getting their money’s worth?  If imagehear from their side, which if focused on reimbursements you might hear a different story but I’ll take the clinical side any day as we know all about the algorithms built for profit and it’s getting harder to do both with better clinical outcomes and at the same time apply fixes for the payments.  Sure hospitals are getting to be a lot smarter with “running the business” but what are we here for, better outcomes or better financial management and you sometimes wonder about the financial side as hospitals are still going broke all over.  BD 


Pay For Performance Is Not All That It Has Cracked Up to Be-Time to Rethink As Money Is Not Creating Better Health Outcomes


(Reuters) - A program to pay hospitals bonuses for hitting key performance measures, or dock them if they miss, failed to improve the health outcomes of patients, according to a large, long-term study.

The study could lead to a re-examination of financial incentives in healthcare, as policymakers seek ways to reward results rather than paying doctors and other providers for each service they provide, such as a diagnostic test.

Such an incentive program for hospitals is a key provision of the U.S. healthcare overhaul law that is being challenged this week before the Supreme Court.

The study looked at pay-for-performance incentives similar to those in the law and found no evidence that the program helped more patients live longer. It was published on Wednesday in the New England Journal of Medicine.

http://www.reuters.com/article/2012/03/28/us-usa-healthcare-compensation-idUSBRE82R1F720120328?feedType=RSS&feedName=healthNews&utm_source=dlvr.it&utm_medium=twitter&dlvrit=309303

 
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