On Death's Door California To Permit Medically Assisted Suicide As Of June 9 :

Debbie Ziegler holds a photo of her late daughter, Brittany Maynard, while speaking to the media in September after the passage of California's End Of Life Option Act. Maynard was an advocate for the law.
Carl Costas/AP

Classic Version of the Hippocratic Oath

I swear by Apollo Physician and Asclepius and Hygieia and Panaceia and all the gods and goddesses, making them my witnesses, that I will fulfil according to my ability and judgment this oath and this covenant: hold him who has taught me this art as equal to my parents and to live my life in partnership with him, and if he is in need of money to give him a share of mine, and to regard his offspring as equal to my brothers in male lineage and to teach them this art - if they desire to learn it - without fee and covenant; to give a share of precepts and oral instruction and all the other learning to my sons and to the sons of him who has instructed me and to pupils who have signed the covenant and have taken an oath according to the medical law, but no one else.

I will apply dietetic measures for the benefit of the sick according to my ability and judgment; I will keep them from harm and injustice.

I will neither give a deadly drug to anybody who asked for it, nor will I make a suggestion to this effect. Similarly I will not give to a woman an abortive remedy. In purity and holiness I will guard my life and my art.

I will not use the knife, not even on sufferers from stone, but will withdraw in favor of such men as are engaged in this work.

Whatever houses I may visit, I will come for the benefit of the sick, remaining free of all intentional injustice, of all mischief and in particular of sexual relations with both female and male persons, be they free or slaves.

What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself, holding such things shameful to be spoken about.

If I fulfil this oath and do not violate it, may it be granted to me to enjoy life and art, being honored with fame among all men for all time to come; if I transgress it and swear falsely, may the opposite of all this be my lot.

A Modern Version of the Hippocratic Oath

I swear to fulfill, to the best of my ability and judgment, this covenant:

I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow.

I will apply, for the benefit of the sick, all measures which are required, avoiding those twin traps of overtreatment and therapeutic nihilism.

I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon's knife or the chemist's drug.

I will not be ashamed to say "I know not," nor will I fail to call in my colleagues when the skills of another are needed for a patient's recovery.

I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know. Most especially must I tread with care in matters of life and death. If it is given me to save a life, all thanks. But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God.

I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person's family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick.

I will prevent disease whenever I can, for prevention is preferable to cure.

I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.

If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.

California will now permit assisted suicide.  

California Gov. Jerry Brown signed landmark legislation last October that would allow terminally ill people to request life-ending medication from their physicians.

But no one knew when the law would take effect, because of the unusual way in which the law was passed — in a legislative "extraordinary session" called by Brown. The bill could not go into effect until 90 days after that session adjourned.

The session closed Thursday, which means the End of Life Option Act will go into effect June 9.
If one carefully compares the classic version with the modern version the modern version contains a new phrase,  "But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God.

Physicians asked to . participate in legal executions have long been uncomfortable performing this function.  Physicians have quietly assisted in hastening death's approach surreptiously with medications.  Patients who are in death's grip are often sedated to diminish pain, and the use of opioids has many side effects on the cardiovascular system.  Now this can be pursued in hospital, or at home with family and/or friends in attendance.
It seems most merciful, and another evolution of medical practice.  Some physicians may refuse to participate, even if the family requests this act.  In such cases a new 'specialty' may emerge, Deathologist.  It no longer is such a horrific word.

Although physicians will be protected legally, the disconnect will remain. 

California To Permit Medically Assisted Suicide As Of June 9 : Shots - Health News : NPR

Clinical Trials, Can Social Media Help ?

ARE SOCIAL MEDIA SAVVY PATIENTS THE BEST-KEPT CLINICAL TRIAL RECRUITING SECRET

PATIENT ADVOCATES AS THE VOICE FOR CLINICAL TRIALS

Patients know how to appeal to other patients. We know what concerns about enrollment are, because we’ve had them. We know the barriers to enrolling, because we’ve faced them. Perhaps most importantly, we know what myths about clinical trials still exist, and can work from the inside out to get rid of them. These myths – that clinical trials are a last resort, that they’re not safe, or that they’re only for certain age groups – are preventing patients from receiving the most forward-thinking treatment available. Patients have a personal incentive to recruit patients to join clinical trials. The more patients who join clinical trials, the potentially faster that drug might come to market as a treatment option for their community. Thus, patients just might be the best-kept clinical trial-recruiting secret.

Cancer communities are forces to be reckoned with, both on social media and offline. Our respective tweet chats, local meet-ups, poster presentations at international conferences about patient reported outcomes, and at times even our own research studies speak to the credibility of our community reach and knowledge.

On Twitter, for example, the #BCSM (Breast Cancer Social Media), #BTSM (Brain Tumor Social Media), and #LCSM (Lung Cancer Social Media) communities share hundreds, if not thousands of tweets and articles related to cancer care each day. Searching through these hashtags turns up journal articles, recent press headlines, organized chats, personal questions and experiences.  It’s as simple as a tweet, really.

Searching for a clinical trial used to only be possible by patients Googling for answers or their physician presenting options in the clinic. Now, patients are flipping the script and searching through Twitter to find information from each other.

Let us not forget Facebook, or Google + and Instagram. All these social platforms provide a . huge network for disseminating information.

Are social media savvy patients the best-kept clinical trial recruiting secret? | Cure Forward

To Pay Or Not To Pay – That Is The Question |Affordable Care Act

K.A. Curtis gave up her career in the nonprofit world in 2008 to care for her ailing parents in Fresno, which also meant giving up her income.

She wasn’t able to afford health insurance as a result, and for each tax year since 2014, Curtis has applied for — and received — an exemption from the Affordable Care Act’s coverage requirement and the related tax penalty, she says.

This year, given President Donald Trump’s promise to repeal the ACA, along with his executive order urging federal officials to weaken parts of the law, Curtis began to wonder whether she’d even have to apply for an exemption for her 2016 taxes.

She also heard that the IRS recently flip-flopped on its previous decision to reject 2016 tax returns that don’t include the taxpayer’s health coverage status.

“I thought, ‘Maybe I won’t have to apply for the exemption again,’” says Curtis, 59. “The public debate about the law makes it confusing.”

Indeed, there’s widespread confusion among consumers about the status of Obamacare, and because of that, they are uncertain how to handle Obamacare-related tax requirements.

Since this article appeared the tax penalty has been overturned by the new White House resident, Donald Trump. And other features are being modified as this is being written.

Should you still submit your 1095 tax forms that show when you were covered — or, if you purchased a plan from an exchange, the amount of tax credits you received? Should you apply for an exemption from the Obamacare coverage requirement?

If you were uninsured in 2016 and don’t qualify for an exemption, should you pay the Obamacare tax penalty?

“Unfortunately, there are a lot of myths floating around,” says Lawrence Pon, a certified public accountant (CPA) in Redwood City. “Some of my clients ask me, ‘Does the law still exist?’”

It sure does.

As a result, California tax experts have some relatively simple advice for confused taxpayers.

“Until Obamacare is no longer the law of the land, we don’t have much choice other than to continue under the current rules and regulations,” says Janet Krochman, a CPA in Costa Mesa.

It is all open to argument and subject to change.  Given this state of chaos I would recomend holding off filing, and wait for a comment or notice from the IRS.  Recent events regarding the ACA have resulted in defacto postponements, or outright nullification of deadlines and other regulatory statement.

On the other hand, other experts make this recommendation.

Many tax preparers say they’d rather not deal with the law’s arcane and complex requirements. But every single one I spoke with says they will continue doing so as long as former President Barack Obama’s health law exists.

“I tell everybody I want all of their forms. We’re going to document everything,” says Rebecca Neilson, a registered tax preparer in Sheridan, about 40 miles northeast of Sacramento. “I’m not going to change what I’m doing because the law might get changed.”

However, a recent IRS switch has fueled hopes among some consumers that the agency won’t enforce the Obamacare tax penalty for 2016.

Then again to add to the confusion

How to dodge the Obamacare tax penalty -- legally

HealthCare.gov Exemptions 

There are many ranging from death in the household, eviction, bankruptcy, and more. Go to the Exemption screening Tool on HealthCare.gov

To Pay Or Not To Pay – That Is The Question | 

The Future of Medical Technology

Technology is improving at an exponential rate. What was once just a hope or a dream is now reality. Hospitals worldwide use complex machines to help diagnose and treat the human body. Advances in areas of technology have been applied to medicine on a massive scale, allowing practitioners to become more specialised in particular areas and revolutionising the way we use and store data.

So what lies ahead for our rapidly advancing technology? What ideas are now in process that could soon become a reality and how might it change our lives? Let’s take a closer look in the infographic below.

So what lies ahead for our rapidly advancing technology? What ideas are now in process that could soon become a reality and how might it change our lives? Let’s take a closer look in the infographic.

AI . Artificial intelligence can be used to detect Alzheimer's disease

Spare parts have been grown.  Brain, Esophagus, Liver, Kidney.

Prosthetics: 3D printing, Integration of processors and implanted brain electrodes

Advanced remote monitoring and televideo

Advances in rapid genomic assays will bring genomic study costs to less than $ 10.00 for focused analytics.

The Future of Medical Technology

Donald Trump Medicaid: Seema Verma, Patient Responsibility | Time.com

Seema Verma (soon to be head of CMS Medicare) would hold  Medicaid recipients accountable.

Seema Verma, President Trump’s pick to lead the Centers for Medicare and Medicaid Service, sees things the same way. Verma, a health policy consultant, helped to reform Indiana’s Medicaid program, working with then-Gov. Mike Pence. With an eye toward competition and personal responsibility, her program, known as Healthy Indiana Plan, mandated monthly contributions from beneficiaries, even individuals at the federal poverty line. There were stiff penalties for missed payments: termination of coverage or transfer to a pared-down plan that offered limited services.

Verma has written that personal contributions are a way for Medicaid recipients to have “skin in the game.” She has said that traditional Medicaid regulations “disempower individuals from taking responsibility for their health, allow utilization of services without regard for the public cost, and foster dependency.”

Verma founded the health policy consulting firm SVC Inc. in June 2001. She is president and CEO of the company, which has worked with the states of Indiana, Iowa, Kentucky, Maine, Michigan, Ohio, and Tennessee.^[1] In preparation for the implementation of Obamacare, Verma and SVC Inc. have worked with state insurance agencies and public health agencies to redesign their Medicaid programs. She developed Medicaid reform programs, including waivers, for Ohio, Kentucky, and Iowa. Her firm provided technical assistance to the state of Michigan in the implementation of their Section 1115 Medicaid waiver. SVC also assisted Tennessee in their coverage expansion proposal and supported Iowa's Medicaid transition to managed care.^[4]

Following the passage of Obamacare, Verma worked with Indiana Governor Mitch Daniels on health care policy.^[5] She was the architect of the Healthy Indiana Plan. The health insurance program, designed for people with low income, requires participants to pay into a health savings account and has high deductibles.^[3] According to Verma, "you have to make your contribution every month, with a 60-day grace period. If you don't make the contribution, you're out of the program for 12 months. It's a strong personal responsibility mechanism." The Healthy Indiana Plan received support from the Indiana legislature and passed into law in January 2008.^[3] She later created the related "HIP 2.0" under Governor Mike Pence.^[3]

In 2014, an article in The Indianapolis Star raised concerns over a potential conflict of interest arising from Verma's dual roles as both a health care consultant for Indiana and an employee of a Hewlett-Packard division that is among Indiana's largest Medicaid vendors. As of 2014, SVC Inc. had been awarded over $3.5 million in Indiana state contracts. Verma was concurrently employed with Hewlett-Packard, earning over $1 million during a period when the company had secured $500 million in state contracts.^[3][6]

Verma was awarded the Sagamore of the Wabash by Governor Pence in 2016. She is a Republican, and her choice obviously was made by Vice-President Pence.

Her appointment comes at a time of significant amendments to the affordable care act, a number of controversial projects by the CMS Innovation Center, including the Accountable Care Organization.   Her significant area of expertise was consulting for the Affordable Care Act in Indiana. This experience brings significant knowledge to the task of restructuring the Affordable Care Act.

Good Luck to you Seema Verma

Donald Trump Medicaid: Seema Verma, Patient Responsibility | Time.com

MS 'brain fog' lifted after stem cell treatment

MS 'brain fog' lifted after stem cell treatment

BBC journalist Caroline Wyatt has spoken of how the "brain fog began to lift" after she had pioneering treatment for multiple sclerosis (MS).

The former BBC defence correspondent was deemed unsuitable for an NHS trial and paid $60,000 (£48,000) for a stem cell transplant in Mexico in January.

Both the FDA and the NHS criteria for suitability for clinical trials are complex and often eliminate patients who have had prior treatments which could confound and yield inaccurate results from a clinical trial.  This screening requirement eliminates large numbers of candiate volunteers from the study.   The criteria are derived from collaboration of principal investigators and the FDA.

Many patients seek out prospective treatments in other countries who have less stringent requirements for receiving new (ie, experimental treatments)

Caroline Wyatt is one of those patients.

Multiple sclerosis

In MS the protective layer surrounding nerve fibres in the brain and spinal cord - known as myelin - becomes damaged. The immune system mistakenly attacks the myelin, causing scarring or sclerosis.

The damaged myelin disrupts the nerve signals - rather like the short circuit caused by a frayed electrical cable.

If the process of inflammation and scarring is not treated then eventually the condition can cause permanent neurodegeneration.

'Aggressive treatment'

She changed jobs but, following a relapse in 2001, she was given a brain scan and told she might have MS - a diagnosis that was confirmed following more invasive tests such as a spinal tap in 2015.  Wyatt initially tried various drug treatments but as her condition began to deteriorate she began to investigate the stem cell treatment.  "I got in touch with Sheffield who were the British arm of a trial... and they very kindly agreed to see me," she said.

"They did various tests but decided in the end that medically speaking I was not one of the best candidates so they couldn't do it here."

Wyatt said that although UK bodies such as the NHS and watchdog NICE describe the treatment as experimental, about 80% of people who had the treatment responded to some degree and more than 50% saw the progression of their MS halted.

Fake News ! It happens all the time in Medicine and HealthCare

Fake news seems to be the new mantra in many quarters.  Fake news can be actively pursued, or passively enjoyed by incomplete, inaccurate, or absent reporting.


Maintenance of Competence (MOC) is an item that few patients are aware.  Specialty boards require re-examination after initial board certification to maintain board certification.

Proponents claim that the Maintenance of Certification program was designed to help physicians keep abreast of advances in their fields, develop better practice systems, and demonstrate a commitment to lifelong learning.

Whether or not the MOC program accomplishes any of these stated goals is a matter of intense debate.

Opponents claim that the Maintenance of Certification program is overly burdensome in both time and expense, reducing time available to spend with both family and patients. The exams have had little relevance to the individual physician's practice requiring tremendous effort to relearn material not useful to daily practice, only useful for passing the board exam. There is no proof that it improves patient care and little to no supporting data except for controversial articles written by board members. Serious questions have been raised regarding Member Board finances.^[2]

Pennsylvania Medical Society PowerPoint by Wesby Fisher, M.D.

The AMA calls for an immediate end to MOC

RESOLVED, That our American Medical Association call for the immediate end of any mandatory, secured recertifying examination by the American Board of Medical Specialties (ABMS) or other certifying organizations as part of the recertification process for all those specialties that still require a secure, high-stakes recertification examination.

Dr Fisher explains how this came to be, and how the American Board of Medical Specialties, the AMA and other physician organizations have engaged in an alleged policy of corruption and profiteering from their own colleagues.

Continuing medical education has served well for many decades as AMA approved courses which functioned adequately to ensure professionalism and currency in medical knowledge.l These courses also are charged for by specialty societies and the AMA.

MOC seems superfluous.   State licensing authorities already require continuing medical education for each licensing period. Physicians are being doubly extorted for the 'right and privilege to earn income.

This who establish these rules are not practicing physicians. 

Patient Safety Awareness Week United for Patient Safety Campaign

During the past ten years an effort to focus on patient safety has yielded significant gains for patient safety.  The week of March 12-18 will bring attention to providers and patients alike.  Safety is a never ending goal in day to day hospital and/or clinic operations.  When procedures become routine and repetitive studies have shown human error intrudes with short cuts or inattention to detail.

The National Patient Safety Foundation

The National Patient Safety Foundation’s vision is to create a world where patients and those who care for them are free from harm. A central voice for patient safety since 1997, NPSF partners with patients and families, the health care community, and key stakeholders to advance patient safety and health care workforce safety and disseminate strategies to prevent harm. NPSF is an independent, not-for-profit 501(c)(3) organization. 

NPSF Vision Statement

Creating a world where patients and those who care for them are free from harm.

NPSF Mission 

NPSF partners with patients and families, the health care community, and key stakeholders to advance patient safety and health care workforce safety and disseminate strategies to prevent harm.

 Improving Patient Safety in Hospitals: A Resource Listfor Users of the AHRQ Hospital Survey on PatientSafety Culture

The Agency for Healthcare Research and Quality (AHRQ) has a resource document which elaborates on many safety issues for hospitals.  It is updated annually.

The AHRQ has programs defining specific areas to be analyzed with recomendations for improvement.  It is available on their website (Quality and Patient Safety Index)

United for Patient Safety Campaign

Doc Vader Goes "Blind Melon" on Patient Demands

Looking for a hospital on WebMD or HealthGrades is NOT like finding a hotel on TRIIPADVISOR. Watch my friend, Doc Vader.











Credits go to: Zdogg MD .   Out!

High-Volume Prescribers and Medicare Prescriptions of Opioids | Substance Use and Addictive Disorders | JAMA Internal Medicine | The JAMA Network

Who prescribes the most opiods?  Several surprises from this study from the Journal of the American Medical Association

Distribution of Opioids by Different Types of Medicare Prescribers

Jonathan H. Chen, MD, PhD^1,2; Keith Humphreys, PhD^1,2,3; Nigam H. Shah, MBBS, PhD⁴; et alAnna Lembke, MD³

Author Affiliations Article Information

JAMA Intern Med. 2016;176(2):259-261. doi:10.1001/jamainternmed.2015.6662

Researchers have suggested that the opioid overdose epidemic¹ is primarily driven by small groups of prolific prescribers and “corrupt pill mills.”^2,3 For example, the California Workers’ Compensation Institute found that 1% of prescribers accounted for one-third of schedule II opioid prescriptions and 10% accounted for 80% of prescriptions.⁴ This propagates a message that opioid overprescribing is a problem of a small group of high-volume prescribers, while general use is likely safe and effective. Medicare data provide the opportunity to address the question of whether such prescribing patterns occur across a national population.

Opioid prescriptions are concentrated in specialty services in pain, anesthesia, and physical medicine and rehabilitation. By sheer volume however, total prescriptions are dominated by general practitioners (family practice, internal medicine, nurse practitioners, and physician assistants).

Contrary to the California Worker’s Compensation data showing a small subset of prescribers accounting for a disproportionately large percentage of opioid prescribing, Medicare opioid prescribing is distributed across many prescribers and is, if anything, less skewed than all drug prescribing. The trends hold up across state lines, with negligible geographic variability. Figure 2 does show greater skewing for total drug costs of Medicare opioid claims, with 78% accounted for by 10% of prescribers. This could be selection of more expensive formulations or higher doses prescribed.

The distribution of any social phenomena has some degree of skewing similar to an “80/20 rule” (eg, 20% of the population controls 80% of the wealth).⁶ As of 2013, however, these data argue that opioid prescribing is no more skewed than other prescribing, reflecting a widespread practice relatively indifferent to individual physicians, specialty or region. High-volume prescribers are not alone responsible for the high national volume of opioid prescriptions. Efforts to curtail national opioid overprescribing must address a broad swath of prescribers to be effective.

MEDICINE CABINET MINEFIELD, HOW OLD PRESCRIPTIONS FUEL THE OPIOID CRISIS

Medicine Cabinet Minefield: How old prescriptions dare fueling an opioid addiction cr

High-Volume Prescribers and Medicare Prescriptions of Opioids | Substance Use and Addictive Disorders | JAMA Internal Medicine | The JAMA Network

Nudging our kids and families towards better eating

Trump Pick for CMS Would Ease Up on Physicians

Seema Verma, MPH, President Donald Trump's choice to head the Centers for Medicare & Medicaid Services (CMS), has mixed feelings about electronic health record (EHR) systems.

It's just one example of how she's on the same page with many physicians regarding healthcare.

"My doctor…is staring at her computer instead of looking at me," the healthcare policy consultant told the US Senate Committee on Finance during her confirmation hearing yesterday.

Seema Verma, CMS administrator nominee for President Trump, smiles during a Senate Finance Committee hearingWashington, DC, on Thursday, February 16, 2017. Source: Pete Marovich/Bloomberg/Getty Images

This is just one example of how provider's recommendations have been purposefully neglected in regard to electronic health records.  The energy of a vast HIT niche have been misappropriated by HHS and CMS in an undisguised effort to harness EHRs for their own interest to collect data.  Little if any effort has been made to the entology of the EHR, or its effectiveness in day to . day activities of providers.  Neither has any oversight or guidance to its usability or efficacy in patient care.

It will take some time and effort to reverse the march toward a singularity of patient care and HIT.

Donald Trump is listening to experts in most areas of government management, including health care management and reform. Billions of dollars have been spent for HIT, at least half of which has been wasted.  The well known incentives were given to providers who could ill afford the huge IT expenditures.  Without that infusion of capital it is doubtful if the IT transformation would have occured.  The special interest group here is the IT hardware and software developers.  Huge EHR firms such as Cerner, Epic and others profitted greatly.

Verma's comment came in response to a question about the future of the CMS incentive program for meaningful use of EHRs, much criticized by physicians for turning them into data entry clerks. She also recounted seeing signs in physician waiting rooms that apologized for schedule delays due to EHR implementation. Yet another tech challenge she cited was the lack of EHR interoperability, which prevents different programs from freely exchanging data.

"We need to make sure [EHR technology] is fulfilling its promise and not being more burdensome," said Verma.

Other 'key elements" will effect Regulations, Mandatory Medicare Pilot Projects,(most of which have failed), and not vetted prior to implementation. Medicare Financial Risk (imposed by a negative incentive to diminish rembursement to providers who do not participate in QA measures.

Verma has some fresh approaches to Medicaid and funding HSA accounts.

She is the architect, for example, of a "consumer-directed" Medicaid program called Healthy Indiana Plan (HIP), which gives beneficiaries there something akin to a health savings account — a Personal Wellness and Responsibility (POWER) account — to apply toward a $2500 deductible. Verma also helped create HIP 2.0, which expanded Medicaid coverage in the state under the ACA with the help of federal dollars.

Launched in 2015 when Vice President Mike Pence was Indiana's governor, HIP 2.0 requires beneficiaries to contribute 2% of their income to their POWER (a Personal Wellness and Responsibility (POWER) account each month. That skin-in-the-game entitles them to extra benefits such as dental and vision coverage.

It remains to be seen if those with limited income do have the financial capacity to contribute 2% especially if there will be copays.

The Congressional Approval Process is in motion

While Senate Democrats appeared vexed at times with Verma, Republicans, who control the Finance Committee, praised her. "We have an outstanding nominee in front of us," said Sen. Michael Enzi (R-WY). "You haven't just studied Medicaid and Medicare; you've done things."

"You have acquitted yourself very well," added Sen. Orrin Hatch (R-UT), the committee chair.

The next step in the confirmation process is for the committee to send Verma's nomination to the full Senate for a final vote.

All in all the changes which may come are encouraging to most.

Trump Pick for CMS Would Ease Up on Physicians

Patient Prescription Advocacy

The next step is to integrate payors into new drug approvals. Many payors will not reimburse for newer therapies due to higher costs for recently developed drugs.  Patent law protects developers for 16 years in order that Pharma companies can recoup their cost for R & D.

Getting the FDA to approve drugs faster is seen as one way to get the access that many patients and their families want. Vice President Pence and many other legislators seem to have been persuaded that the FDA is the roadblock. It isn’t. The real barrier is payers of prescription drug benefits, such as health insurance companies and self-insured employers.

The premise that the FDA needs to speed things up worked in the late 1980s when AIDS activists and cancer groups successfully pressured the FDA to make the drug approval process faster. But this won’t work today because payers, which weren’t nearly as influential 30 years ago, now regulate access to drugs. To speed access to new treatments, then, groups need to incorporate payers into their strategies.

Payers of prescription drug benefits have become crucial in controlling access to drugs over the last three decades. During that time, tens of millions of people gained coverage for prescription drugs. This has improved access to drugs for those with coverage. But it has also taken the decisions that individual patients once made about whether or not to pay for prescriptions and aggregated them under the authority of payers.  Payers make decisions that balance the needs of the covered group as a whole against their organizational objectives, rather than focusing on individual patient situations. Coverage for the group often comes at the cost of an individual patient.

In the early days of prescription drug coverage, payers mostly paid the bills as pharmacies submitted them. But as prescription drug benefit plan costs soared from expanding use and escalating prices, payers began narrowing coverage policies and applying aggressive utilization oversight. Now payers are demanding evidence of drug safety and effectiveness that goes far beyond what the FDA requires for market approval as a basis for prescription drug coverage.

Groups looking to speed access to new therapies need to work with payers to identify clinical benefits and economic value at the same time that they push for rapid regulatory approval. This is not easy during the pre-approval, clinical trial period. However, patient groups and pharmaceutical developers could use their expanded access programs and patient registries to generate the evidence that payers need to evaluate new drugs.

Access to new treatments will not improve just by beating on the FDA. It will mean cooperating with payers, too.

This places the burden for proof of efficacy and cost effectiveness on the patient and the providers.

Perhaps this is a new focus for Patient Prescription Advocacy .  

NYU School of Medicine Working Group on Compassionate Use and Pre-Approval Access

This source of information goes into great deal about the approval process.

The FDA isn’t the only roadblock to accessing to new therapies