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

California Health Care Foundation -- Health Care That Works for All Californians

The Affordable Care Act is at a crossroad.  Repeal or Amend ?  Those are terms which require explanation. To repeal the act without a replacement would be a disaster and tragic for many who have learned how to enter the system. If that were to be jerked away from them it would be premeditated disregard and further increase mistrust in our government.

Knowledgable health professionals would agree the act needs to be significantly amended. This is very possible and most likely.  Many acts and laws have been amended in the past.  Our current political divide near 50/50 with representatives voting along party lines make the task more difficult than it could be.

Resource Center for Amending the Affordable Care Act . This page will be updated regularly

This resource is brought to you by the California Health Care Foundation

As the debate over the repeal of the Affordable Care Act (ACA) evolves, CHCF will maintain a list of data resources and emerging analyses, from CHCF and other organizations, on the potential impact on California. This list is organized by the potential impact of ACA repeal on coverage, economic indicators and health care spending, and insurance market regulations, although some resources span multiple categories. Within each category, resources are organized chronologically.  

Uncertain Future for the ACAFAQs on Repeal and Replace

Our entire health system is a gordian knot of complexity and confounding regulations. It will be a challenge to unravel it without disturbing many sections that work quite well.  The most likely early amendments will be eliminating the individual mandate. which is a . tax penalty for non-enrollment in an approved plan. And despite the law many . people have been granted an exemption for . financial reasons. The law is quite arbitrary, black and white and does not allow for many who have extenuating financial or health concerns.

Updates,  ITUP


California Health Care Foundation -- Health Care That Works for All Californians

On the Path to a Medical Career

During this time of uncertaintly in health care it is important to identify if a medical career is a goal you or your children wish to pursue.

Early decision will make it somewhat easier to decide on the path.  When choosing, most individuals do not know what specialty to chose.

Choosing your career is always difficult – but with many medical careers overlapping in the types of patients they deal with or the locations they work in, budding health professionals really have their work cut out for them.

So what should you consider if you’re deciding between two roles?

Consider your college degree

One of the biggest and most crucial steps in your journey through the health industry is studying for your college degree. If you get a good feeling about a particular subject, chances are you’ll love the job it leads you to.   If you’re unsure whether to become a physician assistant or a doctor, for example, consider the fact that PA qualifications can be as short as two years while medical degrees are far longer. How long would you like to spend in education, and does the course content seem like a good fit for you?

Consider getting some work experience

Another very effective litmus test for your future medical career is to get some work experience. Not only do internships and shadowing placements give you something great to speak about in interviews or on your college application, it also gives you the chance to see the reality of your chosen role.
Want to speak to someone about the stresses of the job, the training and the night shifts? Speak to someone who’s in that position right now, and ask them about the key differences between the roles.

The world of healthcare is extremely varied and interesting. Depending on your qualifications, you could find yourself working on a cruise ship, at a school or abroad – the options for healthcare professionals are practically limitless! Focus on the huge possibilities of your future health career, and we’re sure you’ll find a role that makes you jump out of bed in the morning.

These are many ways to gain exposure to a future career in medicine. Volunteering at a local hospital or clinic, to shadow a physician or to engage in something more exotic, such as a medical internship abroad

Advice for girls and women interested in surgical careers.  In most cases surgical careers are much more demanding of time and commitment, during training and into practice..

Surgery is a demanding career. Do it if you can’t imagine doing anything else. But, if you have the passion, the tolerance for the hard work and the long hours, you will be rewarded by transforming lives.

There are still many challenges to overcome, such as improving work life balance and making childbearing easier for women surgeons. But as I think back on Elizabeth Blackwell, I am heartened that change will come so that the field is truly welcoming to any woman who wants to become a plastic surgeon, have children and maintain a happy marriage.

If you wish to pursue a career in health there are many options besides an M.D. Here is the shortlist;
Physician's Assistant, Laboratory technician, Nurse practitioner,  Nurse, Radiology technician, Pharmacy technician, or Pharmacist.  All of these occupations require less time and education.


It is a good time to enter the health professions. Despite what you hear it is an exciting area to work in.  Motivation as to why you chose a particular field is important.  Perhaps the most is your interest and curiosity about the subject.



Choosing between multiple medical careers

Openness and Transparency | Public Health | JAMA | The EU is way ahead

The European Medicines Agency and Publication of Clinical Study Reports

A Challenge for the US FDA

Anna L. Davis, JD, MPH¹; James Dabney Miller, JD, MPH¹

The US Food and Drug Administration (FDA) has been the standard of drug regulation worldwide for decades. In 1962, in response to the thalidomide tragedy, Congress directed the FDA to evaluate the effectiveness of drugs based on “adequate and well-controlled investigations, including clinical investigations” conducted by qualified experts.

Backed by this congressional enactment, the FDA crafted groundbreaking administrative regulations (eg, the requirements of a prespecified protocol, placebo or active controls, the phasing of clinical investigations, and informed consent from patients) that have guided the global clinical trial enterprise ever since.¹ The FDA’s regulations revolutionized the evaluation of drugs in the United States and abroad.

However, the European Medicines Agency (EMA), the counterpart to the FDA in the European Union, is poised to leapfrog ahead of the FDA in an equally important drug regulatory space of transparency. In October 2016, the EMA published on its website the clinical study reports for 2 drugs (carfilzomib and lesinurad) it recently approved. In so doing, the EMA enabled access to approximately 260 000 pages of detailed clinical trial information, including the protocol, statistical analysis, and detailed clinical data. Although some information was redacted to protect patient privacy, the EMA considered only 2 pages to contain “confidential commercial information.”

he EMA adopted policy No. 0070 to achieve the goals of “better informed use of medicines” and “to make medicine development more efficient” by allowing researchers to “learn from past successes and failures.” The EMA concluded that disclosure of detailed clinical data would enable the development of “new knowledge in the interest of public health.” Whether policy No. 0070 will achieve these goals is an unproven hypothesis, but, by publishing clinical study reports, the EMA has arranged a form of natural experiment that should allow an estimate of the actual benefit, if any, from its new policy.

However, policy No. 0070 faces legal uncertainty. In July 2016, the EU General Court issued an interim injunction that has the potential to undermine or reverse that policy.⁷ In that case, PTC Therapeutics submitted to the EMA a clinical study report of a phase 2 controlled efficacy study of ataluren for the treatment of Duchenne muscular dystrophy. Based on that clinical study report, the EMA conditionally approved ataluren in July 2014. Another unidentified pharmaceutical company requested a copy of the ataluren clinical study report. The EMA offered to redact several portions of the clinical study report, but PTC Therapeutics took the position that the entire clinical study report was confidential commercial information.The challenge the FDA must confront is that the clinical study reports submitted in support of drug marketing applications in the United States are basically the same as in the European Union.⁸ The FDA currently considers clinical data to be confidential commercial information, whereas the EMA does not. The EMA’s policy No. 0070—if it survives the current legal case with PTC Therapeutics—could lead to the anomaly that the EMA proactively publishes clinical study reports online (after decisions are made regarding marketing authorization applications), whereas the FDA withholds the same or similar clinical study reports. Despite the importance of this issue to public health, in neither the United States nor the European Union is there yet clear legal authority on whether clinical study reports should be made public and, if so, under what conditions.

The European Medicines Agency and Clinical Study Reports | Public Health | JAMA | The JAMA Network

TruthinRx . Drug Costs Skyrocket

Spending on US medicine increased 20% from 2013 to 2015 – why are yours so costly? Find out. #TruthinRx

source 

A recent survey of over 3,000 brand name prescription medications found that prices have more than doubled for over 60 drugs since 2014. As the prices of prescription medications continue to rise, physicians have a responsibility to educate their patients.

TruthinRx.org allows patients to learn who controls the prices of their medications and why those prices are increasing. The interactive site provides facts, informational resources and ways that you and your patients can take action to increase drug price transparency.

Have you ever notice the difference in charges for a cash paying customer at the pharmacy ? Do you have one of those generic Rx Discount Cards ?  Does your healthplan get bulk rates ?  Why is a mailorder pharmacy less expensive, and why do some healthplans offer a no copay plan if you order through their own mail order plan ?

Let's do a deepdyve into these questions.
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Your Story about Your Drug Costs
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Prescription medications aren’t like other consumer products. Like food, shelter, and water, they can be a matter of life or death. Yet, patients are left in the dark as to why the price of medicine and their out-of-pocket costs are rising.

The costs of prescription drugs are often negotiated by drug players who aren’t required to disclose their pricing agreements. These middlemen turn a profit, while patients continue to pay a high premium.

If pharmaceutical companies aren’t required to explain their rising prescription drug prices, it could eventually make health care unaffordable for many Americans. Help us protect the future of health care.

Get Informed

Control Your Costs   Click to find out how



Share your story about your drug costs

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