Is the healthcare industry a bubble slowly deflating?

December 3, 2011

Steven Greer, MD- The Healthcare Channel

Two weeks ago, we issued the story, below, about possible layoffs and cuts in the healthcare industry due to a “Healthcare Bubble”. At the medical center level, we said that it would be likely that doctors, normally a profession with great job security and in demand, would see layoffs. To add a real case example to that story, Cedars Sinai in Los Angeles, a medical center with a profit margin far greater than the national average and often the treatment choice for celebrities, is now completely closing its psychiatry department to save money. Their pediatric and OB/GYN services have also been scaled back.

Now, CMS Medicare is planning to make it much more difficult for medical centers to perform the most lucrative of procedures (i.e. spine fusion, joint replacement, and numerous cardiac procedures like stents and ICDs). Just a few years ago, many medical centers greatly expanded their cardiac cath labs to try to perform more coronary stenting. Clinical data and evidence of unnecessary implantation of stents has already decreased the volume of stenting. These new CMS measures might lead to another 20% reduction, according to a cardiologist we spoke with. Spine fusion cases are also very vulnerable to reductions in case volumes due to fears of Medicare audits finding the cases to have been unnecessary.

Already, the bad economy, high unemployment, and fewer insured, have caused reductions in procedure volume. CMS seems to be adding to the strangling pressures. We expect to see significant layoffs in the ranks of spine surgeons, orthopedic surgeons, and interventional cardiologists, if these case volumes are reduced.

Related to stocks, we continue to believe that Medtronic would do well to spin off the spine and ICD divisions. Questions about strategic divestitures were common from callers on the recent earnings call. Edwards Lifesciences (EW) will also face a much more challenging reimbursement climate making for a slower launch of their new TAVR Sapien valve, in our estimation.

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Is the healthcare industry a bubble slowly deflating?

November 15, 2011

By Steven Greer, MD

Throughout the economic depression that began in 2007, the healthcare industry has continued to add jobs. Healthcare providers are still in demand and command good wages and job security. However, can the good times last much longer as the global depression seems to be worsening rather than improving?

The “Super committee” in congress might trigger cuts next week to the HHS Medicare/Medicaid budget and the White House is also advocating cuts. The passage of the ACA health insurance reform law also requires $500 Billion in cuts. Governments have poor track records at making cuts to entitlements, but the private sector might be the most powerful force to enact cuts to the healthcare industry.

With the high unemployment rates has come a lower percentage of the population with full health insurance. This has already had a powerful impact on the healthcare industry. Fewer visits to the doctor and fewer elective (or even not so elective) procedures, combined with a higher mix of low-reimbursing Medicaid, is driving cost consciousness amongst the consumer patients and the hospitals.

We previously reported how newly-approved expensive branded drugs are selling poorly. Once deemed a positive event for a company, an FDA drug approval is now associated with significant reductions in share prices for the companies as investors become disappointed and change their expectations. $100,000 cancer drug prices might represent a pharmaceutical bubble.

JP Morgan’s medical device analyst issued a report detailing many of these repressive influences on the medical device sector. For the large companies such as Johnson and Johnson, Abbott, or Medtronic, the earnings growth rates have decreased from 10% down to 3%, and that is after considerable cost cutting measures were implemented in the form of mergers and layoffs.

Cutting operating expenses is a temporary measure and no substitute for revenue growth. When the companies have trimmed back to the bone, will growth turn negative?

If the ACA law continues to be implemented and is not overturned by the Supreme Court or the new congress next year, it will add millions of patients to the Medicaid system, further stressing state and medical center budgets, will we see salary cuts to doctors and layoffs in the healthcare sector?

If Greece, Italy, Spain, Ireland, etc. send Europe into a double dip depression, what will be the impact to the healthcare industry?

We will be interviewing healthcare economists, policymakers, and hospital executives over the next few months to try to answer some of these questions.

 

Dr. Fran Weaver: Optimal targets for DBS to treat Parkinson’s

Interviewed by Steven Greer, MD

NEJM author Fran Weaver, PhD discusses her randomized controlled data exploring whether the subthalamic nucleus or the globus pallidus is the best location to target with deep brain stimulation electrodes to treat Parkinson’s disease. Neurosurgeon Alon Mogilner offers his opinion on the clinical implications of the research.

 

Alon Mogilner, MD PhD: Deep Brain Stimulation reimbursement

June 15, 2010

Alon Mogilner, MD PhD, neurosurgeon and specialist in neuromodulation procedures such as implanting deep brain stimulation, discusses the financial hurdles limiting the adoption of deep brain stimulation for Parkinson’s and epilepsy, despite sensationally obvious outcomes.

Marcia Crosse, PhD: The GAO report on the 510K process

Marcia Crosse, PhD, Director at the Government accountability Office GAO discuss their report on urgent changes needed in the way medical devices are approved using the lax 510K pathway. The implications to the medical device industry, particularly orthopedics and spine, are significant. Most ortho devices are approved via the 510K.

Produced and interviewed by Steven Greer, MD

The Miami Summit: Comparative Effectiveness Research

July 4, 2010

CurrentMedicine.TV and The University of Miami Health System hosted a roundtable discussion on the general topic of ways to reduce the growth of healthcare spending. The panel of experts were:

• Donna Shalala, PhD, President of The University of Miami and former Secretary of the Health and Human Services Department for eight years under the Clinton administration.
• Pascal Goldschmidt, MD, Dean of The Miller School of Medicine, The University of Miami, and CEO of the UM health System
• Ralph Sacco, MD, Chair of the Department of Neurology, The Miller School of Medicine, The University of Miami
• David Cutler, PhD, Professor of Applied Economics, Department of Economics and Kennedy School of Government, Harvard University, and senior adviser to President Obama on health policy
• Steven Greer, MD, moderator

In Part 3 and 4, The following topics were discussed:

• What is Comparative Effectiveness Research (CER)
• The CREST study on carotid artery stenting v surgery
• Will cost be factored into CER as it is in the UK with the NICE agency?
• The need for customized approaches similar to the way a financial planner optimizes a client’s assets
• How to avoid a one-size-fits-all solution
• The need for better registries and electronic data keeping to make CER work

 

Current guidelines and methods for treating knee and head injuries in NCAA athletes

September 14, 2010

Lee Kaplan, MD, Chief of Sports Medicine at The University of Miami Health System and team doctor for the Miami Hurricanes football team discusses the state-of-the-art methods for surgically repairing torn knee meniscus injuries and for repairing torn ACL’s.

Clifton Page, MD, internists for the Miami Hurricanes football team, discusses the new guidelines for handling the return to play for athletes who have suffered a concussion, testing for sickle cell, and for monitoring heat exhaustion. (See Op-Ed How to Eliminate Head Injury in Football)

David Kallmes, MD: Kyphoplasty versus vertebroplasty

Dr. David Kallmes, professor of radiology at the Mayo Clinic, discusses the differences between balloon kyphoplasty and vertebroplasty.

Brian Kopell, MD: The skull repair and rehab ahead for Rep. Giffords

January 21, 2011

Rep. Gabrielle Giffords is now in a rehab facility. We asked a neurosurgeon, Brian Kopell, assistant professor of neurosurgery at the  Medical College of Wisconsin and practices at Froedtert Hospital, some questions about the reconstruction of her calvaria and her prognosis.

Q1: What have you gleaned from news reports that indicate Rep. Giffords is doing well in terms of higher function?

The main indicator that her recovery has been going well is the rapidity of her improvement.  Her transfer to a rehabilitation facility today indicates that she has achieved a level of motor and cognitive function that is at minimum interactive with her environment.  The reports that she has been tracking her visitors with her vision also indicates a significant level of awareness.  Most interestingly, she has been reported to have been playing with an iPad, certainly demonstrating complex cognitive and motor skills.

That being said, it is a bit curious given the rapidity of her improvement that she underwent tracheostomy.  Generally speaking, this is a procedure done either due to a) significant upper airway/facial injury or b) severe mental status depression where the patient cannot protect their airway.  There has been nothing in the media reports to support either of these scenarios.  Furthermore, there has been no explicit media reports of her writing notes to communicate.  Certainly if she is able to “play” with an iPad she could write simple notes indicating that her language networks are still relatively intact.

Q2: What does her skull look like now? How do they protect the brain?

Based on media reports, Giffords underwent a decompressive craniectomy during her initial operative management of her GSW.  This is a procedure where the surgeons leave the bone flap out to be replaced at a later date should the patient survive the injury.  This is done, quite simply, to allow for brain swelling.  GSW’s, especially high velocity GSW’s,  typically damage the brain in 2 steps.  The initial damage occurs due to the trajectory of the bullet through the brain.  The deceleration of the bullet in the brain causes a pressure wave that damages surrounding brain tissue.  As this damaged brain tissue reacts to this wave, a second stage of damage and swelling commences.  It is often this stage that proves fatal for the patient.  By leaving out the bone flap, the damaged brain can swell without obstruction and consequent loss of blood flow.

Her head looks quite distorted right now; it is probably why the media will not see Ms. Giffords for a while.  Generally,  patients with cranial defects are given helmets to wear in order to protect the essentially un protected brain.

Q3: Where now is the section of the calvaria that was removed When/how will they replace it?

Typically, surgeons do one of two things with the bone flap.  Some make a subcutaneous pouch in the abdomen an place it there.  It is a sterile environment.  Others place it in a sterile refrigeration unit in the hospital specially designed to house such specimens.

We typically replace the bone flap 2-6 months after injury depending on circumstance and patient recovery.  It is a simple procedure in which the old scalp incision is reopened and the bone flap is affixed over the defect with a variety of fixation methods (I use small titanium plates).  Depending on the time elapsed, there can be some significant remodeling of the calvarial defect that requires some drilling of the bone flap in order to make a good cosmetic result.

Should an infection develop, the old bone flap would need to be removed.  In this case, a high-resolution CT can be obtained and a 3D reconstruction of the defect can be modeled.  This information can be used to develop a custom acrylic implant with CAD modeling techniques.

Andre Machado, MD PhD: DBS for depression

November 8, 2010

Andre Machado, MD PhD, Director, Center for Neurological Restoration, The Cleveland Clinic, briefly overviews the possible new indication for deep brain stimulation to treat refractory depression.

Carotid stenting still shown to increase stroke compared to CEA surgery

February 27, 2010

Two major studies were reported this week testing different procedures to prevent stroke: carotid endarterectomy (CEA) and carotid artery stenting (CAS). The CREST study received most of the headlines as a “long –awaited” study that finally vindicated stenting as being as safe as the open-incision neck surgery. The primary endpoint was a composite of: “any stroke, MI, or death within 30 days plus subsequent ipsilateral stroke”. In both the CAS and CEA groups, this composite endpoint was statistically equivalent. However, the pure stroke component was 78% greater for the stent cohort (4.1% v 2.3%), consistent with previous studies. Conversely, the MI component was 110% greater in the CEA group (2.3% v 1.1%).

The other major study released this week was the ICSS from Europe. These data were just from an interim analysis. Therefore, it received less press coverage. In contrast to the CREST study, the primary endpoint in the ICSS was a single clinical outcome of “serious” stroke, which is more clinically relevant. In the stent group, all forms of stroke were 88% greater (7.7% v 4.1%) in the stent group.

Most carotid stenting trials recognize the difference between small brain infarcts from emboli released during the procedure and “serious” strokes caused years later unrelated to the type of preventive procedure. In both the CREST and ICSS trial, the minor strokes caused by the procedure were nearly twice as common with stents. A subset of ICSS patient underwent MRI-imaging and three times the number of stent patients revealed small brain infarcts than the CEA group.

What is a “minor stroke”? A good example was seen in the world of sport a few years ago. The famous New England Patriot All-Pro linebacker Tedy Bruschi suffered a short-term “mild” stroke that forced him to retire. He was partially paralyzed on an entire side of his body.

Proponents of the CREST trial who believe that carotid stenting is a valid alternative to CEA surgery point out that the periprocedural heart attack (MI) rate offsets the risk of minor stroke. However, as was seen recently with Vice President Dick Cheney, modern “heart attacks” are often small infarcts diagnosed only by enzyme elevations. It is unknown at this time how many of the MI’s seen in the CEA group were true Q-wave serious “heart attacks” and how many were “Dick Cheney” attacks.

The HCC interviewed one of the investigators of the CREST trial, Dr. Nick Hopkins, about the issues raised above. Dr. Hopkins is Chairman of Neurosurgery and Professor of Radiology at the University at Buffalo, State University of New York. Regarding the rationale for using a composite endpoint in CREST rather than a single clinical endpoint as in the ICSS, he replied, “Stroke alone ignores one of the most common and important complications of CEA surgery: MI. The composite endpoint is the only “all in” way to evaluate these procedures so clinicians can make intelligent judgments….Doctors will now better understand the risks and benefits of both procedures for each patient so they can make the right choice for each individual. ICSS has many issues and is an interim analysis only.”

Dr. Hopkins declined to comment on the merits of ICSS using the single parameter of “serious” stroke as the primary endpoint. In previous interviews, Drs. Sanjay Kaul, Gordon Guyatt, and Nortin Hadler have explained how composite endpoints can lead to misleading outcomes favoring the drug or device under study.

Critics of the ICSS trial that showed much higher rates of MRI-image-verified new brain infarct lesions and clinically diagnosed stroke point out that the CREST trial used a single type of Abbott device. They also claim that the CREST trial doctors were better trained (see also Dr. White’s comments). Dr. Hopkins wrote, “Credentialing was significantly less rigorous in ICSS than in CREST. “Experienced” interventionalists only had to have done 10 CAS procedures to begin randomization…Telltale numbers…64 CAS procedures were aborted (8%) whereas only 2 CEA’s were aborted…and Experienced centers fared less well than supervised centers. In ICSS two centers were removed from the study but not until they randomized 11 patients resulting in 5 disabling/ fatal strokes. This might suggest CAS operators were overall on an earlier learning curve compared to CREST where we required committee review of data and if that looked good, 20 lead in cases prior to randomization and formal didactic and observational training before randomization.”

One could argue, however, that the ICSS mirrors the real world better than CREST and would likely be what the U.S. would see once Medicare began to reimburse for carotid stenting and let the Genie out of the bottle. Thousands of doctors with little to no experience at carotid stenting and neurovascular anatomy, using numerous different makes and models of stents and filters, would begin stenting millions of patients. The ICSS outcomes are precisely what CMS (Medicare) is hesitant to unleash with a national coverage decision.

The full data from CREST need to be evaluated before the medical community, FDA, and CMS officials can properly weigh the pros and cons of carotid stenting versus CEA surgery. If the MI’s seen in CREST were of the mild enzyme elevation variety, then the temporary paralysis and neurocognitive disability caused more commonly by stenting will not be warranted. On the other hand, permanent vocal cord damage from laryngeal nerve damage and serious Q-wave MI’s during CEA surgery would support stenting.