Monoclonal Antibodies Prevent Severe COVID-19 Disease, Hospitalization and Death

Fast take:

  • Monoclonal antibody therapy is an important but underused treatment for preventing severe disease and death from COVID-19.
  • Monoclonal antibody therapy is the best available therapy for people over 12 years of age who test positive for COVID-19 and who have risk factors for severe disease.
  • It reduces hospitalizations and death by 75% to 85%.
  • It is provided free of charge to any US resident.

Real fast take: Monoclonal antibody therapy is safe; it’s effective and it saves lives: use it!

Monoclonal Antibody Therapy:

Monoclonal antibody therapy is the most effective treatment to date to prevent patients with mild or moderate cases of COVID-19 from developing severe disease, hospitalization, ICU admission, intubation and death. Monoclonal antibody therapy reduces the number of viruses in the patient and lessens symptom severity. It has been demonstrated to reduce COVID-19 hospitalizations and death by 75% to 85%.

When administered within 10 days of onset of COVID-19 symptoms, this one-time treatment is highly effective in killing the virus, preventing symptoms from worsening, and avoiding hospitalization. When administered early, many patients report a rapid and complete resolution of symptoms.

Please remember, monoclonal antibody therapy is not a substitution for vaccination. Vaccination is still the best first line of defense against COVID-19.

What is monoclonal antibody therapy?

This medication consists of antibodies to the virus, quite similar to the antibodies that your own body makes when you are vaccinated or infected with the virus. However, the therapy gives patients an immediate boost in the number of these antibodies. These antibodies are synthesized in a lab. They do not come from other patients.

The monoclonal antibodies kill the virus early before the virus can multiply and make a patient very sick. These antibodies attack the so-called spike protein on the virus, blocking the virus from attaching to a patient’s cells. This slows the growth of the virus within the patient, while the patient’s own body revs up its own natural immunity systems.

The US Food and Drug Administration (FDA) issued emergency use authorization for monoclonal treatments for COVID-19 patients or exposed people, aged 12 and older, who are at moderate or high risk for developing severe COVID-19 disease. This includes many or most adult COVID-19 patients in the US.

Monoclonal antibody therapy involves administering a small amount of medication intravenously (into your vein) over 20 to 30 minutes, or it can be administered subcutaneously (as injections under your skin). The single treatment is followed by an hour of patient monitoring.

This therapy can be administered in an outpatient medical clinic, an emergency room, a long-term care setting such as a nursing home or even in a patient’s home.

For those who would like a more in-depth discussion of the benefits of monoclonal antibody therapy, here is the link to a one hour webinar, with 5 Massachusetts experts, which I moderated for the Massachusetts Health & Hospital Association’s physician leaders on November 22, 2021.

Which patients are eligible to receive monoclonal antibody therapy?

This medication is available for use in patients who are not yet sick enough to be hospitalized and who are at an increased risk for progression to severe disease, hospitalization, and death and who are at least 12 years old.

This therapy can also be given to high-risk patients (for example, nursing home residents) who have simply been exposed to COVID-19, prior to testing positive for COVID-19. We call this prophylactic therapy.

Who is considered at increased risk for severe COVID-19 disease, and therefore an ideal candidate for early treatment with this life-saving disease as an outpatient?

  • Anyone who is
    • Overweight or Body Mass Index (BMI) of greater than 25: use this link to calculate your BMI or
    • Over 65 years old, or
    • Pregnant, or
    • Immunocompromised, or
    • Dependent on a medical technology such as a feeding tube
  • OR any patients who suffer from:
    • Chronic kidney disease, or
    • Diabetes, or
    • Heart disease, or
    • High blood pressure, or
    • Chronic lung disease including COPD, or
    • Sickle cell disease

Please see the complete, regularly updated list of criteria from the Commonwealth of Massachusetts at this link.

If you have tested positive for COVID-19 within the past 10 days, please contact your healthcare professional to discuss monoclonal antibody therapy. The sooner, the better.

Anywhere within the United States, US patients can click here to find a treatment center near you.

Are there side effects to monoclonal antibody treatment?

Allergic reactions can happen with the administration of this medication, like any medication. Patients are therefore evaluated for the development of any signs of allergic reaction for one hour after this one-time treatment.

Most experts believe that these antibodies may limit your own body’s ability to develop an immune response during a subsequent COVID-19 vaccination for a brief period of time. Hence currently, it is recommended that patients delay COVID-19 vaccination for 90 days after receiving monoclonal antibody treatment. Other rare side effects can occur. Feel free to discuss this with your healthcare provider.

Joint MMS – MA DPH announcement:

Just this week, the Commonwealth of Massachusetts’ Department of Public Health and the Massachusetts Medical Society issued this joint statement, strongly urging health care practitioners and providers to consider using monoclonal antibody therapy for their patients who are infected with COVID-19 or have been exposed to COVID-19 when clinically appropriate.

In Summary:

Do yourself a favor; do your family and friends a favor and do me a favor; if you test positive for COVID-19 and qualify for this life saving treatment, seek it out. The life you save may be your own.

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Physician Burnout is a Public Health Crisis Which Needs to be Addressed Now

Last week, the Massachusetts Medical Society – Massachusetts Health & Hospital Association Joint Task Force on Physician Burnout in association with the Harvard T.H. Chan School of Public Health, and Harvard Global Health Institute released a white paper entitled, A CRISIS IN HEALTH CARE: A CALL TO ACTION ON PHYSICIAN BURNOUT.

My friend and colleague, Dr. Alain Chaoui, President of MMS, Michelle Williams, Professor and Dean of the Faculty, Harvard T.H. Chan School of Public Health and I wrote an Op-Ed which appeared in The Boston Globe last week: Doctor burnout is real. And it’s dangerous. In both publications we advocate for for removal of barriers to mental healthcare for clinicians, the employment of Chief Wellness Officers at healthcare institutions and optimization of the current generation of electronic medical records (EMRs).

These recommendations received widespread attention, as they were simultaneously covered by Priyanka Dayal McCluskey in her front page Boston Globe story: Physician burnout now essentially a public health crisis and by Heather Landi in Healthcare Infomatics: Research: Physician Burnout is a Public Health Crisis; Improving EHR Usability is Critical.

The most valuable asset of any organization is the worker on the front-lines. Today, too many of these clinicians are bleeding.

Let’s work together to bring these three recommendations to fruition while helping bring joy back to caring in 2019.

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Medicine is the Deadliest Profession: It Needn’t Be

10 Steps to Prevent Physician Suicide for 2019

Each year, the graduating classes of three average size medical schools don’t add a single physician to the US workforce; they simply replace the 300 to 400 physicians the American Foundation for Suicide Prevention estimates kill themselves each year. We lose a doctor a day to suicide.

In a recent blog post a healthcare CEO asked, “Is the rate of physician suicide statistically different from that of other highly paid professionals?” Yes.

The American Psychiatric Association reported that physicians have the highest suicide rate of any profession at their annual meeting in 2018, higher in fact than active duty military personnel.

The same is true for Finland, Norway, Australia, Singapore and China.

The time to prevent physician suicide, rigorously document its occurrence, remove the stigma of seeking mental health care and to care for suicide victims’ workplace survivors is long overdue.

Physicians know how to stay healthy. This is why it is especially tragic that the only cause of death where the risk to physicians is higher than the general public is suicide.

Worse, we’ve been aware of this slow motion tragedy for generations and it is largely preventable. S. Dana Hubbard, M. D., Director, Bureau of Public Health Education, New York City Department of Health published the fact that physicians lead the list of suicides by professions in the American Journal of Public Health, in 1922.

Almost a century later mystery still shrouds the exact number of physician suicides each year as families and employers alike are reluctant to tell the truth in public, due to the fear of stigma. Medical examiners may have difficulty distinguishing intentional from unintentional traumatic deaths. Even when a suicide is accurately determined, there is no consistent reporting of the victim’s occupation.

Most experts agree the physician suicide rate is roughly twice that of the US population in general, and it is even worse for female physicians. A meta-analysis of physician suicide published in the American Journal of psychiatry demonstrated that both male and females physicians are more likely to die by suicide compared to the general population (1.41 times more likely for male physicians and 2.27 times more likely for female physicians).

The US healthcare system is killing physicians.

Students and young Physicians have been documented to be actually more resilient and less depressed than the US average. Then we are subjected to stress, moral distress and trained to ignore the symptoms of depression until it is too late. A study published in the Archives of General Psychiatry demonstrated that the rate of depression among physicians immediately prior to entering internship was 3.9%. During internship, this rate skyrocketed to 25.7%.

Factors contributing to the epidemic of physician suicide include:

  1. Repetitive exposure to death and dying
  2. Exact knowledge of (and ready access to) lethal means
  3. Stigma associated with asking for mental healthcare and
  4. Our profession’s excessive dependence on self-reliance.

While the first two factors above are likely inherent to the profession, the latter two factors driving suicide are amenable to mitigation.

Here are Ten Suggestions for 2019:

  1. Put an end to the silent curriculum (Don’t ask for help. Never show weakness.”) in physician training programs.

Part of the reason physicians don’t ask for help is that in training we were taught the unwritten rule: “Don’t ask for help and never show weakness.”

On my first day of surgical internship, I was naturally a bit apprehensive, given the enormous privilege and responsibility I was about to be given, caring for, and operating on some of the most ill patients in one of the finest academic medical centers in the US. I was shocked and taken aback by the advice the entire group of us surgical interns were given by the senior attending surgeon, tasked with orienting us. He said, “Always remember that while you are here… you are swimming with sharks. So don’t make waves, and if you are bit, don’t bleed.” It is this kind of abusive attitude which I am confident cost one of my female classmates her life, during her surgical residency when she killed herself halfway across the country in another surgical training program.

We must incorporate wellness into both the written (and silent) curriculum.

2. The Physicians need better access to mental health care without fear of punishment for admitting they need help.

Dr. Michell Hardison, a well-respected family doctor in Raleigh NC chose suicide over psychiatric care for his depression. His daughter Anna Hardison Severn revealed, “He was 100% positive that if he came forward and said he needed help that there would be a reprisal of some kind.”

State medical boards are responsible for licensing physicians and protecting the public by ensuring physicians meet high standards. There is nothing wrong with medical boards asking physicians if they have a medical or psychiatric condition which might lower the quality of the care they deliver. They should not however ask if a physician has ever been under the care of a mental health professional. For if they do this, physicians will forgo needed care which could harm the doctor and jeopardize the quality of the care for their patients.

The Federation of State Medical Boards (FSMB) Workgroup on Physician Wellness and Burnout made 35 recommendations to better address physician burnout. These recommendations should be adopted by all states. They advise against asking probing personal questions regarding a physician’s mental health. The FSMB specifically recommended that state medical boards indicate“it is not only normal but anticipated and acceptable for a physician to feel overwhelmed from time to time and to seek help when appropriate.”

3. Not only should the electronic medical record must be optimized, but processes and systems must be optimized in order to get the most out of this technology and improve user satisfaction.

How it is that healthcare is the only industry where digitization/computerization has decreased worker productivity? The epidemic of physician burnout, driven by administrative hassles, loss of professional autonomy and increasing workloads is contributing to physician burnout, depression and suicide.

It is inexcusable that for every hour physicians spend facing a patient in their office, they are forced to spend two hours tending to desk work and documentation in the electronic medical record.

At UC Davis Medical Health, Scott MacDonald, MD, FACEP demonstrated that by optimizing their electronic medical record’s use, the health system could both dramatically increase physician satisfaction with their EHR and improve their quality of life. They were able to eliminate over 25 hours of unproductive, unnecessary busy work from their physicians’ schedule each month! Imagine how much more time physicians could spend meaningfully caring for their patients and achieving work life balance if this innovation were to be adopted nationwide.

4. Stop the stigma. Employers of physicians, including hospitals, physician groups and residencies must encourage and normalize accessing mental health care.

We must destigmatize and treat physician depression in order to prevent suicide. One study found that access to residency positions was limited for fully qualified students who had requested psychiatric counseling! Only when seeking out a councilor is considered “normal” will physicians ask for help when they need it. All too often, physicians are encouraged to keep vulnerabilities hidden and not ask for help.

5. The practice of requiring medical students and residents to obtain mental health care at their own institution limits confidentiality and should be eliminated.

Until the stigma of obtaining mental health is completely relegated to the ash-bin of history, the confidentiality of accessing such services is critical, particularly for physicians in training. Some student and resident health plans require trainees to obtain healthcare at their own institution, limiting confidentiality for both physical and psychiatric conditions. This paternalistic and antiquated requirement should be eliminated.

6. Peer support should be available at times of great vulnerability:

Medical errors, patient injuries and patient deaths are obviously painful for the patient’s families. Less well understood is the fact that physicians also suffer emotionally in such circumstances, particularly if they believe they have somehow failed their patient and begin to second-guess their own competence.

In times of great stress, such as these or when facing a medical malpractice lawsuit, physicians are extra vulnerable to depression and suicide. It is at these times that confidential peer support, advice from a colleague who has endured the same stressor is most helpful. Employers should plan ahead for such events and offer well-structured and readily available confidential peer to peer support programs to their employed and affiliated physicians.

7. We must accurately keep track of suicide rates by profession. State medical examiners should record the occupation of all suicide victims, including what school they are attending if they are in college or graduate school.

Only then can we identify opportunities for improvement and evaluate whether our interventions are effective in stemming the tide of this horrific slow motion tragedy.

This would capture both the number of physicians / medical students who are committing suicide, and also spotlight any outlier institutions.

8. Postvention: Care for the bystanders after a physician suicide is essential.

Post-suicide counseling and peer support is especially important after a colleague has committed suicide. Toolkits such as the American Foundation for Suicide Prevention’s toolkits are available on line. There is even a toolkit specifically designed for medical schools to utilize after a medical student suicide.

9. Encourage all physicians to select their own trusted primary care physician (and regularly check in with that physician).

All too often physicians follow the dictum, “physician heal thyself.” Employers and affiliated institutions should encourage all medical students, residents and practicing physicians to choose their own trusted primary care physician. In addition to obtaining objective evidence based care from a personal physician, these trusted doctors represent another touch point from which distressed physicians can obtain emotional support.

10. Accessing medical care, whether physical or psychiatric, should be modeled by mentor physicians.

Organizational leaders should model self-care, access mental health care publicly and publicly reinforce the necessity of a healthy work-life balance.

Together we can end the epidemic of physician suicide. Let’s make it happen in 2019.

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The Columbia Gas explosions and Lawrence General Hospital: What they can Teach Us About the Misguided Massachusetts Question 1 Ballot Initiative:

At 4:30 PM, September 13, leaders at Lawrence General Hospital were alerted to multiple natural gas explosions in Lawrence and adjacent Andover and North Andover. That day, gas explosions would simultaneously burn up to 80 houses, injure dozens of people and kill one teenager. Thousands were evacuated from their homes. Many of those residents remain unable to return home. One of the witnesses on the scene of the explosions noted “It looked like Armageddon.” The smoke in the air was reminiscent of lower Manhattan on 9/11. At Ground Zero was Lawrence General Hospital. Upon learning of the incident, Lawrence General Hospital leaders immediately shut down the hospital’s own natural gas supply out of an abundance of caution. Raging fires could be seen burning across the river from the hospital. Smoke drifted onto their hospital campus.

“At the time, I had the horrible thought; what if the nurse staffing ratio law had actually been implemented?”

Leaders at Lawrence General Hospital activated their emergency management plan before the first patient arrived at their doors. This emergency plan included notifying their staff, both within the hospital and those who had the day off.

Everybody did what they could. For example, the Chief Financial Officer, Felix Mercado, (who is an accountant by training, not a clinician) left his office to see how he could best serve the patients and their families in the emergency room. He actually served as a translator that day. Other administrators put on rubber gloves and made sandwiches for the families. The staff at Lawrence General Hospital are proud of the way their community pulled together, as they knew it would in times such as these.

Of the thirteen injured people who were rushed to their emergency room that day, only one person had to be airlifted out, to Massachusetts General Hospital. The rest of the patients were cared for locally at Lawrence General Hospital, a well-known resource for their community.

What if the misguided Question 1 ballot initiative were law that day? Robin Hynds, MSN, RN, CPHM, Executive Director Merrimack Health Network responded that they probably would have been forced to break the law and suffer heavy fines for doing the right thing. She said, “What can we do? Of course we will always take care of the patients. We are the closest hospital to the incident and the best able to provide care locally.” “We support the community. It’s the right thing to do.”

Robin also noted, “At the time, I had the horrible thought; what if the nurse staffing ratio law had actually been implemented? We would have had some hard choices to make, and certainly waits for less urgent care would have been much longer.”

The Boston Globe urges us, “Vote ‘no’ on Question 1. The Nurse staffing ratio is wrong for Mass.

The Lawrence General Hospital leaders I spoke to were proud of the way their on-call and off-duty staff responded. Robin shared, “Many of our nurses came in, on their time off, out of the goodness of their hearts. They were literally running in through the front doors. Physicians too, including trauma surgeons.”

If Question 1 passes this November 6, it would be illegal for hospitals to admit both their routine patients and an unexpected rush of patients from a tragic accident such as the Columbia Gas explosions. This is because the ballot initiative requires a fixed at-all-times rigid number of patients to be assigned to each nurse.

Question 1 is a disaster waiting to happen. The proposed law would require all hospitals to adopt the same rigid, scientifically unproven, one-size-fits-all ratios of nurses-to-patients, at all times – regardless of a hospital’s size, location, or needs of those receiving care.

Question 1 would override the professional judgement and experience of nurses in favor of a rigid government mandate (based on numbers that have no scientific validity). At the bedside, such a law would take real time decision-making power away from professional nurses. In the current system, care team assignments are made based on the ever changing needs of the patients and skill set of nurses.

Question 1 would limit the services hospitals can provide at any given time if they cannot provide enough nurses to fulfill the ratios. Emergency room wait times would dramatically increase, other services will be delayed, and patients would be forced to travel extended distances for care as hospitals scramble to assign and re-assign nurses to fulfill each ratio as the number of patients fluctuates.

Question 1 would be ridiculously complex to implement: I urge you to read the ballot initiative and see for yourself: For example, it specifies 4 different nurse to patient ratios in the Emergency Department (from 1:1 for “critical patients,” 1:2 for “critical stable patients;” 1:3 for “urgent stable patients,” and 1:5 for “non-urgent stable patients.”) How could this even be implemented in the ED, where patients’ conditions change minute by minute?

Isn’t healthcare already expensive enough in Massachusetts? The Massachusetts Health Policy Commission, an independent state agency, recently issued a report that the ballot question would cost upwards of $900 million annually.

Question 1 would cripple community hospitals. Some community hospitals, perhaps yours, would be forced to close if Question 1 passes. This is particularly true for hospitals outside of Boston. Other hospitals will be forced to make painful, significant service reductions in order to keep their doors open.

The Boston Globe states, “Vote ‘no’ on Question 1. The Nurse staffing ratio is wrong for Mass.”

I am a physician and I am voting No on 1. I urge you to vote no on Question 1 too.

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Accountable Specialist Care: a Transformational Alternative to Fee For Service Medicine

 

Healthcare reform focused on our primary care providers is doomed to fail because most US healthcare spending is driven by specialists.

Quick-take:

  1. US healthcare spending is excessive, wasteful and unsustainable, given the aging of the US population.
  2. Specialists drive the bulk of US healthcare spending.
  3. To rein in US healthcare spending, specialists must be committed, aligned and engaged.
  4. Specialists will not be committed, aligned and engaged unless their interests are protected or enhanced.
  5. Accountable Specialist Care (ASC) is a feasible proposal to fundamentally transform specialist reimbursement, eliminate waste and can be embraced by specialists.
  6. Savings come not from cutting specialists’ income, but by eliminating unnecessary procedures, and recouping the much higher, “technical component charges,” from eliminated procedures.

“Our core belief is that about 40% of what doctors and hospitals do is wasteful. If you can extract that percentage of crap, you can redistribute it into savings and profits but also into procedures that actually help patients,”says Dr. Glenn Steele, Geisinger’s former president. 

Reducing healthcare waste requires that those who control the bulk of healthcare costs (specialists) must be incented to become true partners, directionally aligned and absolutely committed to waste elimination. If not, the United States will continue our unsustainable trajectory to ever higher healthcare costs, worsening federal budget deficits, flat or declining real incomes (as increasing healthcare costs vacuum up all of the money otherwise available for raises) and declining competitiveness in the world market.

With 10,000 baby boomers entering Medicare every day, Medicare’s trustees note that the US Medicare Hospital Insurance trust fund will become insolvent in 2026, in 8 years. We have three choices to prevent Medicare insolvency:

  1. Relentless fee cutting, which I posit cannot be sustained by most hospitals and physician groups,
  2. Rationing, which may be politically and socially untenable, or
  3. Eliminating wasteful and potentially harmful practices, through aligning incentives of providers, patients and society.

Problem Statement

Most experts agree that 30% to 40% of the “healthcare” we deliver is unnecessary. “Our core belief is that about 40% of what doctors and hospitals do is wasteful. If you can extract that percentage of crap, you can redistribute it into savings and profits but also into procedures that actually help patients,”  says Dr. Glenn Steele, Geisinger’s former president. The Dartmouth Atlas studies have demonstrated that high cost Medicare care can be associated with a lower quality of care.

There is an old saying, to a man with a hammer, everything looks like a nail.

Background:

There are huge “gray zones” in medicine where no established best practice is clear. For example, when I fractured my own shoulder (which is demonstrated on the CT images below) I was offered a choice of a $7000.00 to $10,000 surgery to immediately bolt the broken bone back together, with the potential of surgical complications such as infected hardware… or I could choose to place my arm in a $50 dollar cloth sling until the broken bone healed.

 

 

Different surgeons I spoke with had differing opinions on which option was best, but most suggested surgery. After my last surgeon consulted several of his mentors, he recommended, and I chose, the $50 dollar sling.  I fully recovered, avoided the unnecessary expense and risk of surgery and I now enjoy full shoulder strength and a completely normal range of motion.

There is an old saying, to a man with a hammer, everything looks like a nail.  In the current fee for service (FFS) world, a surgeon is paid much more for operating on someone than for recommending conservative therapy. This contributes to an unconscious bias towards surgery in such gray zone cases.

ASC, savings do not come from reducing specialist payment, but rather from specialists eliminating unnecessary and costly tests and procedures.

Accountable Specialist Care (ASC) is a feasible proposal to fundamentally transform specialist reimbursement. ASC totally removes this unconscious bias by eliminating specialist fees for doing stuff to patients and aligns specialist payment with performance, population health, value and outcomes. ASC, savings do not come from reducing specialist payment, but rather from specialists eliminating unnecessary and costly tests and procedures.

Unlike ASC, in today’s alternative payment models such as the Medicare Shared Savings Accountable Care Organizations (ACOs), the more patients a surgeon operates on, the more he gets paid. This drives waste.

Most of the expense for such unnecessary tests, procedures or surgeries actually go to pay for the “technical component” of the test or surgery. This “technical component” payment pays for the operating room, the MRI scanner, the surgical implant, etc.  Under ASC, specialists are fully paid, regardless of how many procedures or surgeries they perform, as long as the patients’ outcomes and experiences are good. Unlike ASC, in today’s alternative payment models such as the Medicare Shared Savings Accountable Care Organizations (ACOs), the more patients a surgeon operates on, the more he gets paid. This drives waste.

In the ASC model, specialists are rewarded for creating value for their stakeholders, not for doing more “things” to patients. The creation of this value will require the specialists to perform additional real work: research, stakeholder meetings, discussions with patients and referring physicians and administrative work for implementation. The value created will far outweigh the costs of this additional work. But unless the incentives are realigned, and specialists are protected from harm, specialists will remain reluctant participants in healthcare reform, rather than innovative leaders of disruptive value creation.

In exchange for a salary guarantee, and ASC specialist must identify unnecessary, low value and potentially harmful care they were previously delivering and eliminate it.  

What is ASC?  A key component is specialist group subcapitation, that is each specialist group (such as orthopedic surgery, cardiology, radiology) receives a fixed fee per patient per month regardless of how many procedures the patient receives. Also included in ASC are identification of best practices, implementation of best practices and benchmarks for patient satisfaction, population health and referring physician satisfaction.

Specialists salaries: One way to look at how specialists are paid is to look at the current Rube Goldberg fee schedule, the contractual discounts offered to over 500 different insurance plans, the alternative payment models specialists may be engaged in and the supplemental payments for hitting quality targets, budget targets, etc.

The ASC way to look at specialist salaries: Look at the total number of patients a specialist group was responsible for last year, look at their total income for last year and divide the payments by the number of patients.  This yields a per patient per year figure. This is in fact what the specialist group was paid. If this figure is divided by 12, it yields a per patient per month fee.

Key to ASC payment methodology is to continue paying the specialist group the same per patient per month fee, in exchange for certain deliverables.  In exchange for this salary guarantee, the specialist must identify unnecessary, low value and potentially harmful care they were previously delivering and eliminate it.  This generates huge savings as the technical component fees are eliminated. This enhances patient well being and paradoxically will enhance the specialists’ well being. Going forward with wasteful procedures eliminated, the specialist will receive the same income and more time off.

Example specialty, Radiology: Nationwide, the volume and cost of medical imaging has skyrocketed during my 32 year tenure as a radiologist. Some of this has accrued to our patients’ benefit.  With modern cross sectional imaging, highly accurate and specific treatable diagnoses are generated by the radiologist, so that the patient can be triaged to the most appropriate care plan.

This has been a mixed blessing however.  On the one hand, the cause of a myriad of symptoms from every body part can be non-invasively and quickly diagnosed with medical imaging. On the other hand, given our litigious society, failure to image a patient with a significant condition can result in some of the highest medical malpractice awards. Understandably, if a doctor believes there is even a remote chance medical imaging will benefit the patient, a scan is requested, often unnecessarily. This results in wasteful, low value care. Making matters more challenging, the very same symptom which can and should lead to advanced medical imaging, can in its less severe forms, be a common and ubiquitous condition.  How then are the ordering clinicians to determine when imaging is appropriate? With help from an ASC radiologist.

ASC radiologists will be held accountable for:

  • Improving patient satisfaction.
  • Improving population health, for example ensuring patients receive screening mammography.
  • Improving physician satisfaction.
  • Improving report turnaround time.
  • Periodically reviewing the world’s literature to ensure only indicated studies are performed.
  • Calling critical exams and reports to referring physicians.
  • Standardizing the imaging follow up of incidental, probably benign findings, utilizing evidence based best practices.
  • Reducing over-utilized, high-cost, high-volume examinations, such as CT pulmonary angiography.
  • Implementing computer assisted Clinical Decision Support (CDS).
  • Ensuring that all suggested follow-up studies made by a radiologist in a subspecialty that they don’t not have fellowship level training in (or its equivalent in experience) be double read by a subspecialist radiologist to ensure the follow-up imaging is appropriate.

For any proposal to have a significant effect in the real world, it must be designed in such a way that the specialists making the decisions which drive healthcare costs can enthusiastically embrace this change.

Currently, radiologists’ financial incentives under the current fee for service (FFS) model encourage increased provision of services and punish any process which thoughtfully reduces scan (procedure) volume. This is inherently inflationary, and is a contributing factor to the unsustainability of our current healthcare system, and it is generalizable to other specialties.

In the past, many plans to decrease utilization have been developed, without the input or true buy-in of practicing radiologists, none of which have had substantial success in reining in the costs of unnecessary and wasteful radiology imaging. Historical utilization management techniques have included command and control mechanisms by the regulatory authorities, such as Certificate Of Need programs, pressure put on radiology groups by Physician Hospital Organizations and ACOs and prior-authorization requirements instituted directly by insurers.

I would argue the reason these prior processes have largely failed is that they did not involve the radiologists, a key stakeholder, in their development and they ignored the financial ramifications on, and incentives of, this key stakeholder group.

ASC incents radiologists to become enthusiastic supporters of the transition to pay for value, rather than reluctant foot draggers. As an example of the foot dragging mindset, the chair of one of the most prestigious radiology departments in the US noted in his presentation about the recently enacted Affordable Care Act (ACA)  in 2010, “Alternative payment systems will take years to implement -thank goodness… they have the potential to hurt radiologists if current attitudes toward the specialty are maintained.” (Emphasis added by me.)

For any proposal to have a significant effect in the real world, it must be designed in such a way that the specialists making the decisions which drive healthcare costs can enthusiastically embrace this change. Only with such buy-in can we fundamentally transform specialty reimbursement, focus our resources on care that matters and align incentives toward improving patient care.

Within today’s ACA enabled ACOs, all other things being equal, the specialist will gain more revenue if he provides more services, as specialists are still reimbursed by FFS with today’s Medicare ACOs. Specialists might hope the other specialists decrease their utilization appropriately, so that there would be shared savings. But they have little financial incentive to cut their own utilization. Cutting specialist utilization directly and disproportionately cuts that specialists’ income. This results in the perverse incentive to deliver more services, rather than healthy outcomes, and is an example of the tragedy of the commons. This perverse incentive is completely mitigated in the ASC model, as specialists’ salaries are not dependent on the volume of services they provide, but rather on waste elimination among other quality metrics. Without the ASC model, this tragedy of the commons is a sizable barrier to fully realize the potential of the ACO model.

Brandeis Professor Stuart Altman coined  Altman’s law; “While a majority of people desire healthcare reform in the abstract, their second choice, if they personally have to make a sacrifice to accomplish the reform, it to maintain the status quo.” The ASC model respects Altman’s law by aligning specialist, patient and societal incentives. It improves patient care and drives specialist commitment toward dramatic elimination of wasteful healthcare spending.

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Crowdsourcing Solutions to Physician Burnout

(Your help is needed to influence CEOs nationwide.)

Physician burnout is a public health crisis. Yet many healthcare CEOs don’t fully appreciate the significance of this silent epidemic. Only prioritization by CEOs can bring about the cultural change necessary to address the systemic causes of physician burnout.

 

Recently I had a thought provoking conversation with a successful healthcare CEO. He had read the Health Affairs blog PHYSICIAN BURNOUT IS A PUBLIC HEALTH CRISIS: A MESSAGE TO OUR FELLOW HEALTHCARE CEOS. Yet he wasn’t convinced this global statement was sufficiently backed up by enough facts in the brief article.

 

Through years of personal experience I know that this CEO cares deeply about his patients, his staff and his physicians. He noted as CEO, he already has many priorities. Before his organization takes on an additional priority (addressing physician burnout) he needs to better understand why this issue should displace other pressing concerns. He has been hearing more about the issue in the past couple of years, and he wonders if it deserves the attention it is receiving. He said that he assumed if he could tell me what he was thinking, I could more effectively change his mind on the subject.

 

He raised a dozen important questions. In order to convince him, and other healthcare executives to expend significant attention and resources to combat physician burnout, I suspect we need to clearly and convincingly answer his questions, heavily supported with evidence based literature.

 

Your answers to his questions will help CEOs and board members across the country effectively prioritize this silent epidemic.

 

A dozen questions related to physician burnout (posed by a thoughtful hospital CEO)

1. What can the literature on physician burnout teach us about what will work to resolve this issue?

 

2. What is the underlying etiology of burnout; is physician burnout an individual response to stimulus versus an industry-wide systemic issue?

 

3. What is the evidence to suggest that physician burnout is a significant and compelling issue warranting the level of attention it is getting?

 

4. Regarding physician suicide, the rate is higher than that which is reported in the general public. Is the rate of physician suicide statistically different from that of other highly paid professionals?

 

5. Is the reporting of only one symptom of physician burnout truly a manifestation of moderate or severe burnout?

 

6. The Health Affairs blog states that the consequences of burnout threaten our US health system. Some may find the link between having one symptom of burnout and a real threat to the entire health system a pretty big jump. What is the evidence to support this conclusion?

 

7. If it is the push from outside regulators, legislators, public and private payers, EHR manufacturers, etc. which is the main force contributing to loss of physician autonomy and happiness, won’t we need to effectively address these stakeholders underlying concerns in order to successfully convince them to alter their policies?

 

8. The Health Affairs blog’s list of responses is heavily weighted to what everyone else needs to do to unburden doctors.  If one steps back 20 steps and looks at this from a historical perspective; physicians and providers are being told what to do, because cost is too high and  outcomes too poor. We, the insiders in this system, have not effectively convinced the public that:

  • we are as safe as we can be
  • we don’t waste resources
  • we don’t have unwarranted variation
  • we are not motivated too frequently by money (with supply creating demand,) and that
  • we are producing outcomes equal to other countries that have much lower costs.

Until we internally fix the healthcare delivery system we will continue to see the push for more oversight, more quality measures and more use of data.    Won’t pushing back at regulators ultimately fail, unless the underlying reasons for their concern/activism are also successfully resolved?

 

9. Is the call to alleviate physician burnout due to a significant threat to the entire healthcare ecosystem, or due to the fact that physicians are more powerful?  (In that they are highly intelligent, historically autonomous, socially powerful and able to push back against change more successfully than other groups facing similar industry change.)

 

10. What is the responsibility the individual physician to develop and improve individual resilience (possibly through lifestyle changes related to diet, exercise, sleep, healthy habits etc.) versus what is the responsibility of those of us who oversee large segments of the entire healthcare ecosystem to address systemic causes of physician burnout?

 

11.  Is physician burnout a manifestation of resistance to necessary change within the healthcare ecosystem or something more than that?

 

12. Will a big public push to address the systemic causes of physician burnout create value, be neutral or create harm for all stakeholders, most importantly the public?

 

We all want the same things, safe and effective care for our patients, patient satisfaction and cost effectiveness. None of this can happen without a healthy, resilient workforce.

 

Would you please help by answering a few of these questions? Please feel free to comment or send me an email at  Steve@DefoSays.com

 

I will be sharing the answers to these questions, one or two per week as your answers become robustly convincing.

 

Thanks in advance and enjoy your summer!

 

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Prescription for the US opioid crisis: An interview with former congressman Patrick Kennedy (Part 2 of a two part series)

  • In this hard hitting, no holes barred interview, former Rhode Island congressman Patrick Kennedy discusses what it will take to successfully combat and reverse our generation’s biggest public health crisis, the opioid epidemic.  Does the US have the will for success?

Steve Defossez: What do you think it will it take for this country to develop the political will necessary to actually stem the tide of the opioid crisis?

Patrick Kennedy: Not to sound like a downer but …we couldn’t wrap our arms around the invisible wounds of war for our citizen soldiers the way we need to do to address suicide; (acknowledging the obvious tragedy of 23 soldiers dying a day, in many cases for totally preventable suicides). If we couldn’t get a significant tranche of money for the opioid crisis given the epidemic that’s ongoing, it’s really hard for me to know what it is going to take to spur that kind of political will.

Steve Defossez:  Once an effective treatment for HIV-AIDS was discovered, the death rate from HIV-AIDS started coming down right away. Yet similarly effective medication assisted therapies were developed for opioid use disorder years ago, and they have not been widely deployed; hence the death rate from opioid overdose continued to increase.

Patrick Kennedy:  The comparisons are that during the HIV-AIDS epidemic, we were spending $24 billion a year to save these patients. And that made a big dent changing the whole fatal nature of HIV-AIDS. Today, we’re spending less than half $1 billion, on the opioid epidemic when we were spending $24 billion on the HIV-AIDS epidemic.

(It should be noted after this interview, Congress passed and the president signed the recent bipartisan spending bill which does include 4 billion dollars to combat the opioid epidemic. This is not allocated solely to fund treatment, however. It also funds opioid prevention, research and law enforcement.)

Steve Defossez: We need to open up people’s eyes to the fact that the genetic predisposition to addiction, like karma, is written indelibly into our genes at the moment of conception. Opioid addiction is as much of a “physical disease” as appendicitis is.

Many patients really want to feel normal again, to get out of the cycle of withdrawal symptoms and use, but they don’t see an alternative to avoid withdrawal besides the use of heroin.

I was told by a hospital CEO in the US Southwest that, when a patient without medical insurance presents to their emergency department with an opioid overdose, they are resuscitated and then immediately discharged back into the community, with no hope of accessing medication assisted therapy, because medication is simply unavailable to patients without insurance in her county. It’s stunning that in a country as rich as ours, which spends 20% of its GDP on healthcare, there is no treatment for these patients.

“And the persistence of this problem is so inexcusable.”

Patrick Kennedy:  What’s also stunning is that the hospital CEO wouldn’t follow-up that statement by saying, “and I have therefore made a directive that as hospital CEO, my staff and my doctors will provide that medication assisted treatment, and we are going to work with our local community college to get the necessary peer support specialists etc. We will do that right here on the campus of our hospital.” That’s the appropriate follow-up line. Everyone thinks it needs to be someone else’s job, you know, send them somewhere else. And if they are rich, they can fly to some other part of the country. When in reality, they need to go to their hospital right down the street, where they go for everything else; they need to go there for this care too.

Steve Defossez: And today there isn’t parity. If that patient was pregnant and in labor, they wouldn’t say “oh, you don’t have insurance, leave the hospital.”  But for patients suffering from opioid substance use disorder, they do say that.

“Bottom line; hospitals and doctors need to offer medication assisted therapy, as part of their moral responsibility…”

Patrick Kennedy: And the persistence of this problem is so inexcusable. Because as I said the template is pretty simple. They’re going to have an injectable medication. There are several companies coming up with different forms of injectable buprenorphine (medication). All of the insurance companies said they’re going to be reimbursing for this. CMS (Centers for Medicare & Medicaid Services) could easily do a bump up in opioid use disorder reimbursement payment. I’ve talked to them about doing this and they may well be on the track to doing that.

Patrick Kennedy: Bottom line; hospitals and doctors need to offer medication assisted therapy, as part of their moral responsibility, as the chief healthcare provider in the community. It’s hospitals that need to do this, it’s doctors that need to do this.

Patrick Kennedy: The AMA needs to step up. We know it takes eight hours of training to become certified to utilize these medications to treat substance use disorder. Physician organizations should just say you know what? We are going to incentivize that training. We’re going to make payment increases for substance use disorder a top priority. In addition, we are working with the National Council Of Behavioral Health to provide wraparound services. So doctors, you don’t need to do anything but write a prescription for the buprenorphine. Let the community mental health activists and those in the community recovery movement take it from there.

“It’s disappointing that there is so much lack of imagination in the space.”

Patrick Kennedy: This can be put together. I’ve run campaigns, not only for my own case, but for many others, for a long time. We know what the essential elements are for a good campaign. We know how to do it. The playbook is roughly the same. You make some small changes depending on where you are. This is not complicated stuff. It’s not a heavy lift to do. And I guarantee you that a lot of insurance companies would like to do this, because they don’t like the increased costs foisted on the system by undertreatment of opioid addiction.

Patrick Kennedy: With alternative payment models, such as Accountable Care Organizations (ACOs), hospitals and providers are increasingly taking on insurance risk, and are responsible for the total cost of care. They do better financially when they deliver high quality care, utilizing  the fewest resources. In an ACO model, hospitals could negotiate increased reimbursement rates for providing mental health treatment and treatment for opioid addiction with these insurers. The rationale would be that we are going to treat the whole person, and be rewarded with lower overall healthcare costs and healthier patients. There are experts who can show that if we treat opioid addiction appropriately, we can easily expect to achieve over a four times lower cost of “physical healthcare” costs. This is the real result of putting somebody into a chronic care management program for addiction.

Patrick Kennedy: There is no rational way to explain why this isn’t already being done. It’s not because we don’t know what to do. It’s not as if we don’t have the reimbursement mechanisms that can be devised to make this a value proposition, especially in this new era of value-based payments. It’s disappointing that there is so much lack of imagination in the space.

“It would be my bet that perhaps one of the single biggest returns on investment in healthcare that we could expect today is to improve the quality of our mental health delivery system, as part of our healthcare system.”

Steve Defossez: Do you think integrated care is the future of mental health and addiction service delivery? What needs to happen to increase its uptake?

Patrick Kennedy:  We need to align the financial incentives for optimal outcomes across the entire mental health – physical health spectrum. The optimal outcome is the reduction in the reoccurrence of illness, complications to illnesses and unwanted conditions such as readmissions to the hospital. If mental health issues factors into that, then pay for mental health treatment, at least to the degree that mental health factors into reducing those bad outcomes. It would be my bet that the current lack of mental health treatment factors into contributing to bad health outcomes in a big way.

Patrick Kennedy: In fact, it would be my bet that perhaps one of the single biggest returns on investment in healthcare that we could expect today is to improve the quality of our mental health delivery system, as part of our healthcare system. This is because of how much it’s going to do for the rest of healthcare. I think that unfortunately, the value proposition to cancer will be depression treatment. The value to diabetes could be alcohol treatment. The value to all kinds of intellectual and developmental disabilities will be prenatal care. There are five times as many babies born today with alcohol and drug related complications than there are kids born with autism. The bottom line is, it is integration, integration, integration. Mental health in each and every one of those areas of medicine can be the decisive factor in changing the health of our population.

Steve Defossez: That’s right. 5% of the US public consumes 50% of our healthcare. When you talk to people who work in emergency rooms, there are patients who come into the emergency room several times a week, because of anxiety issues or homelessness and because they don’t have access to more appropriate and less expensive care.

Steve Defossez: A friend of mine is a healthcare CFO in California who noticed one of their patients (who was not particularly ill) was spending $200,000 a year on unnecessary emergency room visits. The patient was checking into the emergency room every two or three days with one complaint or another. When the CFO evaluated the root cause of this behavior, he discovered it was because the patient was homeless. So this CFO somehow arranged to get this patient a stable apartment. The following year, what you think the insurance company spent on his healthcare? The answer is the patient stopped visiting the emergency room altogether. The insurance company didn’t spend one penny on this individual’s health care the following year.

Steve Defossez: I’m not a constitutional scholar but we all know cruel and unusual punishment is banned by the US Constitution. I’m pretty sure if we addicted prisoners of war to opioids and then forced them to go through withdrawal, this would be considered torture. Yet that’s just what we do in the criminal justice system. If someone goes into jail with diabetes, no one thinks twice about giving them insulin. But I understand almost nobody gets medication assisted therapy for opioid use disorder while incarcerated. Hence they’re forced to go through withdrawal and suffer cravings. Particularly with the long acting injectable medications you discussed, proponents of this unconstitutional policy can’t use the argument that these medications might be used illicitly within the prison. Am I wrong that failure to provide medication assisted therapy is a violation of the US Constitution, and a violation of the Parity Act which you spearheaded in Congress?

Patrick Kennedy: That’s right, and then you have the very real incarceration of people with these illnesses and also people with full-blown psychosis, banging their heads against the jailhouse doors. I’ve seen that going into these prisons. We are in a bad place in this country regarding the treatment of people with mental illness including those with addiction.

Steve Defossez: The United States is an outlier in that we incarcerate more people on a percentage basis than any other nation. Part of this is that we incarcerate more people with mental illness than we hospitalize.

Patrick Kennedy: That sounds about right. That’s what we ended up doing, shifting them from the “asylums” to the new asylums which are obviously our jails and prisons.

Steve Defossez: Where you think the future of opioid substance use disorder is headed, including the concept of supervised injection facilities (SIFs)?

Patrick Kennedy:  We have long acting buprenorphine in phase 2 trials. Indivior just gained FDA approval for a monthly injection of buprenorphine this past November

Some of the existing long-acting medications come with a catch in that they were administered through a large-bore painful needle. But now they are developing these new long acting injectable medications which can be injected through a tiny needle, like your flu shot. You’d only have to adjust a little bit of titration down from the use of heroin,  prior to starting treatment with these medications. These injectables satisfy cravings and protect a person from overdose.

Steve Defossez: Yes, I understand these new long acting buprenorphine medications do not require patients to go through withdrawal or detox before use.

Patrick Kennedy: So it seems to me our first urgency ought to be to get these types of products out, because to your earlier point, people are looking for a way to stop that cycle of in – out, in – out. Substance use followed by detox, followed by substance use then detox. If you can stop the cravings and use, you can prevent them from overdosing.  Why isn’t this treatment more widespread? Because it’s out there, it’s not fantasy.

Patrick Kennedy: I understand the harm reduction of supervised injection facilities SIFs, but it’s kind of like what you do when you have no other options. My point is we have these other options, let’s double down on our options, and put these injectables in every doctors’ office in the country, like we do with our flu shots. I know they’ve had success with SIFs in Canada.  I’m on my way to Philadelphia now, so I should learn more about SIFs soon.

Steve Defossez:  The safe injection facility concept is that people bring in the stuff from the street because they don’t want to stop today but they do want to not die. So they bring it in from the street and this does allow the employees to take microscopic samples of the heroin to see what’s out on the street, whether it’s fentanyl, elephant fentanyl etc. If the person overdoses in the building, they can be resuscitated so they won’t die. And of course because it’s a medical facility, there are staff there who can teach the patient how to inject in a sterile fashion so they don’t get bacterial heart infections, HIV-AIDS, hepatitis etc. While there, patients also have access to first-aid for superficial infections, a warm shower and food.  Every encounter is a touch point where someone explains to the patients that when they are ready to choose recovery, we can offer that too.

Patrick Kennedy: I like that. I was very much for safe needles exchange 20 years ago in Providence when I was first a state representative there. And God, it was so hard to get it passed and now, you know, it’s obvious these days.

Conclusion: Every American should awaken to this simple fact: if this scourge has not yet found you or your family, without bold action by everyone, it soon will. I ask you to support cost-effective and life-saving medication assisted therapy by emailing your elected state and federal senators and representative and express your support for adequate funding for and widespread dissemination of this life saving therapy.

 

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Mental health should be treated as part of overall health: An interview with Former US Congressman Patrick Kennedy (Part 1 of a two part series)

As we learned with racial segregation, separate is not equal. Insurance plans should cover all diseases equally.  In America, perhaps due to stigma or prejudice, insurance plans have historically paid more generous benefits to what they called “physical health” as opposed to “mental health” and substance use disorder (addiction) treatment. In medicine, it is often said that behavioral health care is paid the lowest fees, and within behavioral health, the very lowest fees are paid to treat substance use disorder.

In 2008, Former US Representative Patrick Kennedy was a chief sponsor of the Mental Health Parity and Addiction Equity Act (MHPAEA). This bill was signed into law under President George W. Bush, as part of the Troubled Asset Relief Program also know as TARP. Let’s hear what he has to say about parity today:

” When you think you’ve done it, check again. Historical biases and prejudices have a sneaky way of infiltrating our practices.”

Steve Defossez: What can hospitals and health systems do to make sure we finally see full implementation of the 2008 Mental Health Parity Act (the federal parity law)?

Patrick Kennedy: Well, we have to change our cultural predisposition towards these issues. Historically, we segregate mental health issues to the margins of healthcare. Why? because they were not seen as real healthcare issues. Unfortunately that’s the backdrop from which we come. So if I were to emphasize anything, it’s that when you think you’ve done it, check again. Historical biases and prejudices have a sneaky way of infiltrating our practices.

Patrick Kennedy: We don’t know what the future looks like in healthcare delivery because it hasn’t happened yet. We know academically that mental health is essential health and the brain mediates the health of the whole body. We know that you can’t properly treat any illness without treating the mental illness as well, which may underlie it. Mental illnesses often underlie physical diseases. Depression and anxiety are often co-occurring with all other major illnesses and physical disabilities. I would say that we need to start with the parity law because it’s very tangible and easy to wrap our arms around. Ask yourself, are we treating mental health and addiction the same way we treat physical and surgical diseases? Do patients with mental health issues have the same access to inpatient and outpatient care? Is this true for in-network providers and out-of-network providers? Do patients with mental illness have the same pharmacy benefits (coverage and deductibles) and the same ER benefits as patients with “physical disease?”

Patrick Kennedy: The parity law (which requires health insurance plans to pay for mental illness treatments just as it pays for physical illness treatment) is not just for payers. Hospitals are increasingly becoming part of these Accountable Care Organizations (ACOs) which are taking on insurance risk. This concept of bifurcating (separating) the payer from the provider; that obviously is quickly becoming a thing of the past.

“Lack of access to mental health care and addiction treatment… is driven by money and the lack of resources.”

Steve Defossez: How does the current system fail to treat behavioral health issues the same as so called, “physical health?”

Patrick Kennedy: One needs to really understand the practices of insurance plans to see the discrimination occurring today. Technical insurance procedures, including:

  • medical necessity determination, (where an insurer can determine that a procedure is not “medically necessary” and therefore not pay for it.)
  • retrospective review (where an insurer can fail to pay for a service which has already taken place)
  • prior authorization (a time consuming hoop physicians need to jump through, in order to get the insurer to approve a service. If the service is performed, even if medically necessary, the insurer will not pay for it unless prior authorization is obtained first.)

These insurance procedures, and others often result in inadequate payment of those who provide mental health services.

This, of course, has led to the historic lack of access to mental health and addiction treatment. By the way, every hospital system and every state is still suffering from lack of access in terms of the inability to really address this public health opioid epidemic. And there is lack of access just to address the day-to-day needs of every patient. All of that is driven by money and the lack of resources that have gone into paying for reimbursement for professionals in mental health. The lack of payment for providers and other ancillary services can actually increase cost and lead to worse outcomes.

Patrick Kennedy: For example, we know stable housing produces as big an impact on stable mental health as anything else you can do on the medical side. We need to do more to provide access to stable housing, and this will be cost effective, as it reduces healthcare costs. We know the science of mental health. It’s not always just biological in terms of its intervention. Social services can be as important as medications. So we need to treat the delivery of mental health services as scientific. If you do that, we can start to move away from this cultural bias among medical staffs and hospitals that this somehow is not what they do. In fact, in order to achieve better outcomes using fewer resources, ACOs need to be thinking about how they address the mental health component of all diseases, whether it’s oncology, cardiovascular disease, diabetes or what have you.

The time for healthcare parity is long overdo. Unless we make it known that our behavioral health benefits are not equal to our physical health benefits, nothing will change, If you experience second class treatment for a behavioral health issue, please contact your state’s insurance commissioner, US representative, US senator or me at Steve@DefoSays.com.

Please be on the lookout for the next and final installment (Part Two) of our two part interview with Former US Representative Patrick Kennedy, where we will address the US opioid crisis.

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A Dozen Cures For Overpriced Pharmaceuticals

(Part three in a three part series)

 

1. Don’t fall victim to pharmaceutical value-based price anchoring: After Touring pharmaceuticals increased the price for Daraprim from $13.50 to $750 per pill, Stephen Lederer, a spokesman for Turing demurred, the pricing for Daraprim reflected its clinical value.

Imagine if surgeons priced their surgery this way: A surgeon is called to the bed of a 13 year old boy with a burst appendix and says, “Son, you have to ask yourself what is the ‘actual value’ of being alive for another 70 years? 6 million dollars you say?  Well, then you should be happy to pay 5 million dollars for me to remove your appendix.”  If the patient objected, the surgeon might add, “OK, I’ll enter into a value based contract with your insurer, and only collect the money if the surgery works.”

Don’t let the drug companies fool us into anchoring the price negotiation at the value of life, rather than the production cost of the drug.

2. Radical transparency: Sunshine is the ultimate antiseptic. Drug makers should publicly divulge the true cost of research and development for each drug, as well as what they charge for it. This is particularly true as healthcare is increasingly viewed by society as a right, not an option.

Vermont recently passed a law to this effect. Vermont requires drug makers to provide cost data on the 15 most costly drugs the state purchases.

One cannot identify, let alone fix, market breakdown until one views price in conjunction with cost. With fundamental production cost transparency, a miracle cure may still justify a higher price, but only if its development costs support that pricing.

3. Regulate big pharma like a public utility: Currently, their intellectual property rights allow brand name pharmaceutical companies unlimited pricing power for new drugs. This is the definition of a monopoly. Markets are not free if there is only one vendor. In America, if a product is considered essential, (such as electricity) we intervene in the market. Utilities open their books to utility regulators, and based on the cost of production, prices are set.

With pharmaceutical market breakdown, drug prices bear no relationship to the cost of production. A multidisciplinary regulatory commission can price a drug taking into account cost, overhead and reasonable profit, while protecting the public from price gouging.

4. Support the fledgling generic startup, Fair Pharma:  Today, ruthless generic companies can corner the market by purchasing the sole generic manufacturer of a critical life saving drug, and overnight raise its price, 3000%.  According to a recent report, when Valeant Pharmaceuticals purchased the rights to Cuprimine, used to treat a rare genetic disorder, Valeant next increased Cuprimine’s price from from $8.88 to $262 per pill.

Fair Pharma is a new nonprofit generic manufacturer spearheaded by Intermountain Healthcare.  Fair Pharma is essentially a consortium of hospitals and health systems who have decided to band together to produce their own reliable supply of low cost generics. Their mission is not to maximize quarterly profits, but to maximize the free supply of low cost, high quality generic drugs to their patients and their customers’ patients.

5. Support drug reimportation or show me the dead Canadians: Patients in Canada and other countries pay 30% to 50% less than US patients because their governments successfully negotiate with the drug companies for significant discounts.

We could capitalize on these lower prices by allowing US drug stores and patients to re-import these less expensive drugs back into the US. This option is currently illegal. The supposed rationale for banning reimportation is that reimported drugs are somehow counterfeit, of low quality or unsafe. To which we paraphrase former Minnesota Gov. Tim Pawlenty, “show me the dead Canadians.”

Canadians are not dying from low quality pharmaceuticals.  The reimportation ban is in actuality political payback to pharmaceutical firms. It is against the public interest. These medications are safe and purchased from the same manufacturers we buy them from.

Re-importation of drugs from Canada has support from activists on both sides of the political spectrum. Senator Bernie Sanders and President Donald Trump have both called for legalization of drug reimportation recently. 72% of Americans support allowing the reimportation of prescription drugs from Canada. Contrary to some paid alarmists, this can be accomplished safely. Most of these drugs are actually manufactured within the US already.

6. Allow the US government to negotiate drug prices: Canada and European countries successfully negotiate with the drug companies for significant discounts. The US government should likewise negotiate the price of the drugs it purchases. The US government is the largest purchaser of these drugs in North America. Yet US taxpayers pay more than any other consumer in the world for these medications. In any rational market, we would be entitled to a discounted price. This is a grotesque example of the US Congress capitulating to a special interest as opposed to representing the public interest. Congress actually passed a law making it illegal for the government to negotiate the price of the drugs it purchases.

This common sense solution enjoys overwhelming support from the US public; 92%. It also enjoys bipartisan support: Senator Bernie Sanders and President Donald Trump both support this obvious cost savings. Change the law. Enough said.

7. Use generics when appropriate: Hospitals, physician groups and health plans should encourage doctors and other prescribers to use lower cost generics whenever there is a lower cost generic of equivalent effectiveness.

8. Encourage so called “step therapy”: Step Therapy is an approach where inexpensive yet effective medications are tried first, prior to the prescription of more expensive medications.

9. On long term stable medications? Buy them in bulk. Encourage patients who are on chronic, long term, stable medications to buy them in bulk from the most cost effective source, often mail order.

10: Support prescribers with Clinical Decision Support: Encourage Electronic Health Record developers to include effective pharmacy Clinical Decision Support in order to insure prescribers have updated information regarding drug cost and efficacy at the point of order entry (when they are actually prescribing the medication).

11. Payer transparency: Insurers should provide patients and physicians alike with an up to date, fully transparent formulary of covered medications, alternatives, including information on patient co-pays, differing price tiers and generics.

12. Eliminate TV advertising by the drug companies to the consumer:  The American Medical Association supports this solution, as they fear this advertising unnecessarily drives up demand for expensive drugs.

This would remove a large cost from the pharmaceutical industry.  The only other developed country in the world which allows drug company executives to advertise directly to the public is New Zealand. (New Zealand physicians are also lobbying for a ban there too.) Banning ads will result in reduced drug prices, reduced inappropriate demand for drugs by patients and therefore, reduced medical harm from unnecessary side effects.

Perversely, given the complex US tax code, US taxpayers are actually subsidizing the very ads which drug companies utilize to drive up demand and prices for their products. Drug company TV ads are currently considered a legitimate tax deductible business expense.

I ask you to support these cost-effective and life-saving proposals by emailing your elected federal senators and representative to express your support for for this path to the future.

 

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The US Pharmaceutical Market, Merciless and Inefficient: Part Two

Market Breakdown in Need of Repair: part two in a three part series

Previously, in Part One of this series, we discussed what’s good in the US pharmaceutical market.

Today in Part Two: we explore the Bad and the Ugly

  • Generic drug price gouging
  • Market breakdown
  • Deceptive marketing

Later this month, Part Three will develop a path to the future

  • “Show me the dead Canadians”
  • Public private partnerships
  • Market reforms

Why should you care?

Drug prices are higher in America than anywhere else in the world. We pay 34% more than New Zealand and 50% than England. Essentially, patients in the US are subsidizing the cost of pharmaceuticals all over the world.

The systemic weaknesses in our pharmaceutical industrial complex contribute to wasting of billions of dollars each year. This diverts scarce resources away from more pressing needs and is rapidly driving the US healthcare system into insolvency. For example, inexplicably the state of Massachusetts paid $244 for Mylan’s EpiPen in 2012 and subsequently paid $362 for it in 2014.”

A recent Massachusetts Health Policy Commission report indicates that spending on prescription drugs accounted for one third of all Massachusetts healthcare spending growth in 2016. This spending is growing more rapidly than any other healthcare category.

Last year for the first time in history, Massachusetts spent more money on pharmaceuticals than on inpatient hospitalizations. The rate of growth of pharmaceutical spending is too high, and dangerously escalating, squeezing out other priorities at every level of government and in the private sector.

Generic drug price gouging and market breakdown

In an efficient free market, once the patent on a drug has expired, generic manufacturers should be able to compete based on quality, service and cost. This should drive drug prices down. Yet there are examples of oligopolies (only a few manufacturers in the market) or true monopolies (only one manufacturer) in the generic market where US drug price gouging has garnered headlines recently. For example:

CEO who raised price of old pill more than $700 calls journalist a ‘moron’ for asking why

This after Turing Pharmaceuticals unconscionably raised the price of a treatment for a parasitic infection from $13.50 to $700 per pill!

There have been cases where a generic drug is made by one or only a few manufactures, and the firm is bought, with the sole objective of ratcheting up the price of the generic medication.

Another scheme which brand name drug companies use to stifle competition is to pay generic drug manufactures not to produce a lower-cost equivalent generic medication. This effectively delays any competition in the market and has been labeled, “pay-for-delay.” According to a Federal Trade Commission report, it’s estimated that these pay-for-delay schemes cost Americans $3.5 billion per year.

How ridiculous is this? Some have argued that sky high drug prices are a bargain, because these true miracle cures are cheaper than the alternative.  For example, the alternative to the pharmaceutical miracle cure for hepatitis C is for the patient to develop end stage liver disease, hope to get off the liver transplant waiting list and then receive a $100,000.00 liver transplant.  We are told the new drug is, “cost effective,” because it only costs $84,000.00, rather than the $100,000.00 required for a liver transplant.  Really?

Imagine your new car develops a flat tire.  You bring it into the shop and the mechanic tells you a new tire will cost $16,000, and you should consider this “cost effective” because this “miracle cure” to your car’s ailment is cheaper than not repairing the tire and having to purchase a new car for $20,000. You would leave the shop either in fits of laughter, or steaming mad.  Luckily in the real world, you will likely find a new tire for less than $100.

What’s the difference between a new tire and a new pill?  There is an efficient free market for the new tire, and complex market breakdown in the pharmaceutical market.  The patient is not free to walk away from a cure.  The patient is not the one who negotiates the fee and often not the one who pays for the drug. The government gives the drug company years of patent protection, which eliminates competition, and then at the end of that time, the drug companies often use lawsuits or pay-for-delay to prolong their monopoly.

In an efficient market, innovations such as flat screen TVs are expensive at first, but as technology evolves, markets drive prices down.  As an example of how a free market operates, JVC introduced the first VCR in 1977 at a price of $46,000.00 in today’s dollars. The VCR tapes alone cost 72$ (in today’s dollars). But innovation, competition and scale has driven down the price of recording a show to essentially zero today.  Market breakdown, an oligopoly in the generic market, huge barriers to entry and lawsuits, as well as “pay for delay” prevent US patients from reaping the benefits of the free market.

Deceptive marketing:

A key prerequisite for deceptive advertising is severely asymmetric knowledge between the advertiser and the buyer.

Years ago, we banned cigarette advertising to children because kids did not have the sophistication, education and experience to keep from getting hoodwinked into addiction by the tobacco companies. It’s time we do the same for direct drug advertising to the public.

A recent report notes that drug companies spent 19 times as much money on advertising than they did on research.  More than 10% of this advertising ($3 billion) was spent advertising directly to potential patients.  How is it helpful to tell the public to, “ask your doctor if the purple pill is right for you?”

Later this month, in Part Three of this series, we will suggest a path to the future, with specific actionable recommendations to rectify these market imbalances.

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