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Archive for the ‘Federal Budget Appropriations’ Category


Real Time Coverage @BIOConvention #BIO2019: After Trump’s Drug Pricing Blueprint: What Happens Next? A View from Washington; June 3 2019 1:00 PM Philadelphia PA

Reporter: Stephen J. Williams, PhD @StephenJWillia2

 

Speaker: Dan Todd, JD

Dan Todd is the Principal of Todd Strategy, LLC, a consulting firm founded in 2014 and based in Washington, DC. He provides legislative and regulatory strategic guidance and advocacy for healthcare stakeholders impacted by federal healthcare programs.

Prior to Todd Strategy, Mr. Todd was a Senior Healthcare Counsel for the Republican staff of the Senate Finance Committee, the Committee of jurisdiction for the Medicare and Medicaid programs. His areas of responsibility for the committee included the Medicare Part B and Part D programs, which includes physician, medical device, diagnostic and biopharmaceutical issues.

Before joining the Finance Committee, Mr. Todd spent several years in the biotechnology industry, where he led policy development and government affairs strategy. He also represented his companies’ interests with major trade associations such as PhRMA and BIO before federal and state representatives, as well as with key stakeholders such as physician and patient advocacy organizations.

Dan also served as a Special Assistant in the Office of the Administrator at the Centers for Medicare & Medicaid Services (CMS), the federal agency charged with the operation of the Medicare and Medicaid programs. While at CMS, Dan worked on Medicare Part B and Part D issues during the implementation of the Medicare Modernization Act from 2003 to 2005.

Cost efficiencies were never measured.

Removing drug rebates would cost 180 billion over 10 years. CBO came up with similar estimate.  Not sure what Congress will do. It appears they will keep the rebates in.

  • House  Dems are really going after PBMs; anytime the Administration makes a proposal goes right into CBO baseline estimates;  negotiations appear to be in very early stages and estimates are up in the air
  • WH close to meet a budget cap but then broke down in next day; total confusion in DC on budget; healthcare is now held up, especially the REBATE rule; : is a shame as panel agrees cost savings would be huge
  • they had initiated a study to tie the costs of PartB to international drug prices; meant to get at disparity on international drug prices; they currently are only mulling the international price index; other option is to reform Part B;  the proposed models were brought out near 2016 elections so not much done; unified agenda;
  • most of the response of Congress relatively publicly muted; a flat fee program on biologics will have big effect on how physicians and health systems paid; very cat and mouse game in DC around drug pricing
  • administration is thinking of a PartB “inflation cap”;  committees are looking at it seriously; not a rebate;  discussion of tiering of physician payments
  • Ways and Means Cmmtte:  proposing in budget to alleve some stresses on PartB deductable amounts;
  • PartD: looking at ways to shore it up; insurers 80% taxpayers 20% responsible; insurers think it will increase premiums but others think will reduce catastrophic costs; big part of shift in spending in Part D has been this increase in catastrophic costs
  • this week they may actually move through committees on this issue; Administration trying to use the budgetary process to drive this bargain;  however there will have to be offsets so there may be delays in process

Follow or Tweet on Twitter using the following @ and # (hashtags)

@pharma_BI

@AVIVA1950

@BIOConvention

@PCPCC

#BIO2019

#patientcost

#PrimaryCare

 

Other articles on this Open Access Journal on Healthcare Costs, Payers, and Patient Care Include:

The Arnold Relman Challenge: US HealthCare Costs vs US HealthCare Outcomes

Centers for Medicare & Medicaid Services announced that the federal healthcare program will cover the costs of cancer gene tests that have been approved by the Food and Drug Administration

Trends in HealthCare Economics: Average Out-of-Pocket Costs, non-Generics and Value-Based Pricing, Amgen’s Repatha and AstraZeneca’s Access to Healthcare Policies

Can Blockchain Technology and Artificial Intelligence Cure What Ails Biomedical Research and Healthcare

Live Conference Coverage @Medcity Converge 2018 Philadelphia: Oncology Value Based Care and Patient Management

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CMS releases MACRA rule proposal: Will HHS force physicians to drop fee for service for fee for outcome?

Streamlined implementation aims to increase flexibility, decrease reporting burden for physicians

The U.S. Department of Health and Human Services unveiled a proposed ruletackling the initial implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

According to an HHS announcement accompanying the rule, the primary aim is to simplify and streamline the existing patchwork of value-based payment models that have increasingly replaced the traditional fee-for-service system via a new framework dubbed the Quality Payment Program. This structure provides doctors with two paths for compliance:

The Centers for Medicare & Medicaid Services expects most providers to opt for the MIPS track initially, according to CMS Acting Principal Deputy Administrator and Chief Medical Officer Patrick Conway, M.D., who spoke on a conference call announcing the rule.

Participation in Advanced Alternative Payment models would exempt doctors from MIPS reporting requirements while also qualifying them for financial bonuses in exchange for taking on the risks related with providing “coordinated, high-quality care,” according to CMS. The agency expects both the number of physicians participating in this track and the number of payment models available to grow over time.

CMS also reports that doctors will have the flexibility to switch among various components of the Quality Payment Program as dictated by the needs of their patients or their practices.

Opinions from around the web

In this video, Gilberg, senior vice president for the Medical Group Management Association’s Government Affairs Office, discusses CMS’ Physician Value-based Payment Modifier. In 2015, Medicare will begin applying the modifier under the physician fee schedule to various providers to show value of care.

“Cost and quality … make up the value equation, in the mind of the payer, in terms of Medicare,” said Gilberg.

In addition to explaining how the modifier works, Gilberg also highlights other quality measures facing providers under the Physician Quality Reporting System and via the EHR Incentive Programs, better known as meaningful use.

View Video at

http://www.physicianspractice.com/mgma14/understanding-medicare-value-based-payment-models

When the Medicare Access and CHIP Reauthorization Act (MACRA) legislation passed in April 2015, everyone cheered the repeal of the Sustainable Growth Rate (SGR) formula for Medicare physician payment. Now, even before the MACRA regulations are even promulgated, it’s time to pay attention because Medicare physician payments in 2019 will be impacted by their performance in 2017, just a year from now.

Other related articles

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Problem of Science Doctorate Programs

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

 

The Problem in Biomedical Education

Henry Bourne (UCSF)

Dr. Henry Bourne has trained graduate students and postdocs at UCSF for over 40 years. In his iBiology talk, he discusses the imminent need for change in graduate education. With time to degrees getting longer, the biomedical community needs to create experimental graduate programs to find more effective and low cost ways to train future scientists and run successful laboratories. If we don’t start looking for solutions, the future of the biomedical enterprise will grow increasingly unstable.

Watch Henry Bourne’s iBioMagazine: The Problem in Biomedical Education

https://youtu.be/V9peRqNr-L0

Henry Bourne is Professor Emeritus and former chair of the Department of Pharmacology at the University of California – San Francisco. His research focused on trimeric G-proteins, G-protein coupled receptors, and the cellular signals responsible for polarity and direction-finding of human leukocytes. He is the author of several books including a memoir, Ambition and Delight, and has written extensively about graduate training and biomedical workforce issues. Now Dr. Bourne’s research focuses on the organization and founding of US biomedical research in the early 20th century.

Related Talks

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Peer Review and Health Care Issues

Larry H. Bernstein, MD, FCAP, Reporter

https://pharmaceuticalintelligence.com/12/1/2014/Peer-Review-and-Health-Care-Issues

(Medscape – Dec 1, 2014)

Peer-reviewed journals retracted 110 papers over the last 2 years. Nature reports the grim details in “Publishing: the peer review scam”.

When a handful of authors were caught reviewing their own

papers, it exposed weaknesses in modern publishing systems.

Editors are trying to plug the holes.

 

The Hill reports that the FDA may lift its ban on blood donations from gay men. The American Red Cross has voiced its support for lifting of the ban.

Advisers for the Food and Drug Administration (FDA) will meet this week to decide whether gay men should be allowed to donate blood, the agency’s biggest step yet toward changing the 30-year-old policy.

If the FDA accepts the recommendation, it would roll back a policy that has been under strong pressure from LGBT advocates and some members of Congress for more than four years.

“We’ve got the ball rolling. I feel like this is a tide-turning vote,” said Ryan James Yezak, an LGBT activist who founded the National Gay Blood Drive and will speak at the meeting. “There’s been a lot of feet dragging and I think they’re realizing it now.”

Groups such as the American Red Cross and America’s Blood Centers also voiced support of the policy change this month, calling the ban “medically and scientifically unwarranted.”

The FDA will use the group’s recommendation to decide whether to change the policy.

“Following deliberations taking into consideration the available evidence, the FDA will issue revised guidance, if appropriate,” FDA spokeswoman Jennifer Rodriguez wrote in a statement.

This reporter has more than 20 years of Blood Bank experience.  The factor in favor of the recommendation is that the HIV 1/2 and other testing is accurate enough to leave the question of donor lifestyle irrelevant.  However, it remains to be seen whether the testing turnaround time is sufficient to prevent the release of units that may be contaminated prior to transfusion, which is problematic for platelets, that have short expirations. In all cases of donor infection, regardless of whether units are released, a finding leads to not releasing the product or to recall.

 

Democrats made a strategic mistake by passing the Affordable Care Act, Sen. Charles Schumer (N.Y.), the third-ranking member of the Senate Democratic leadership, said Tuesday.

Schumer says Democrats “blew the opportunity the American people gave them” in the 2008 elections, a Democratic landslide, by focusing on healthcare reform instead of legislation to boost the middle class.

“After passing the stimulus, Democrats should have continued to propose middle class-oriented programs and built on the partial success of the stimulus,” he said in a speech at the National Press Club.

He said the plight of uninsured Americans caused by “unfair insurance company practices” needed to be addressed, but it wasn’t the change that people wanted when they elected Barack Obama as president.

“Americans were crying out for an end to the recession, for better wages and more jobs; not for changes in their healthcare,” he said.

This reader finds the observation by Senator Schumer very perceptive, regardless of whether the observation in hindsight might have had a different political outcome.  It has been noted that President Obama had a lot on his plate.  Moreover, we have not seen such a poor record of legislation in my lifetime.  There are underlying issues of worldview of elected officials that also contribute to the events.

 

THE PEER-REVIEW SCAM

BY CAT FERGUSON, ADAM MARCUS AND IVAN ORANSKY

N AT U R E |  2 7 N O V  2 0 1 4; VO L 5 1 5 : 480-82.

Most journal editors know how much effort it takes to persuade busy researchers to review a paper. That is why the editor of The Journal of Enzyme Inhibition and Medicinal Chemistry was puzzled by the reviews for manuscripts by one author — Hyung-In Moon, a medicinal-plant researcher then at Dongguk University in Gyeongju, South Korea.

The reviews themselves were not remarkable: mostly favourable, with some suggestions about how to improve the papers. What was unusual was how quickly they were completed — often within 24 hours. The turnaround was a little too fast, and Claudiu Supuran, the journal’s editor-in-chief, started to become suspicious.

In 2012, he confronted Moon, who readily admitted that the reviews had come in so quickly because he had written many of them himself. The deception had not been hard to set up. Supuran’s journal and several others published by Informa Healthcare in London
invite authors to suggest potential reviewers for their papers. So Moon provided names, sometimes of real scientists and sometimes pseudonyms, often with bogus e-mail addresses that would go directly to him or his colleagues. His confession led to the retraction of 28 papers by several Informa journals, and the resignation of an editor.

Moon’s was not an isolated case. In the past 2 years, journals have been forced to retract more than 110 papers in at least 6 instances of peer-review.

PEER-REVIEW RING
Moon’s case is by no means the most spectacular instance of peer-review rigging in recent years. That honour goes to a case that came to light in May 2013, when Ali Nayfeh, then editor-in-chief of the Journal of Vibration and Control, received some troubling news. An author who had submitted a paper to the journal told Nayfeh that he had received e-mails about it from two people claiming to be reviewers. Reviewers do not normally have direct contact with authors, and — strangely — the e-mails came from generic-looking Gmail accounts rather than from the professional institutional accounts that many academics use (see ‘Red flags in review’).
Nayfeh alerted SAGE, the company in Thousand Oaks, California, that publishes the journal. The editors there e-mailed both the Gmail addresses provided by the tipster, and the institutional addresses of the authors whose names had been used, asking for proof of identity and a list of their publications.ew rigging. What all these cases had in common was that researchers exploited vulnerabilities in the publishers’ computerized systems to dupe editors into accepting manuscripts, often by doing their own reviews. The cases involved publishing behemoths Elsevier, Springer, Taylor & Francis, SAGE and Wiley, as well as Informa, at least one of the systems — could make researchers vulnerable to even more serious identity theft. “For a piece of software that’s used by hundreds of thousands of academics worldwide, it really is appalling,” says Mark Dingemanse, a linguist at the Max Planck Institute for Psycholinguistics in Nijmegen, the Netherlands, who has used some of these programs to publish and review papers.

A 14-month investigation that came to involve about 20 people from SAGE’s editorial, legal and production departments. It showed that the Gmail addresses were each linked to accounts with Thomson Reuters’ ScholarOne, a publication-management system used by SAGE and several other publishers, including Informa. Editors were able to track every paper that the person or people behind these accounts had allegedly written or reviewed, says SAGE spokesperson Camille Gamboa. They also checked the wording of reviews, the details of author-nominated reviewers, reference lists and the turnaround time for reviews (in some cases, only a few minutes). This helped the investigators to ferret out further suspicious-looking accounts; they eventually found 130.

SAGE investigators came to realize that authors were both reviewing and citing each other at an anomalous rate. Eventually, 60 articles were found to have evidence of peer-review tampering, involvement in the citation ring or both. “Due to the serious nature of the findings, we wanted to ensure we had researched all avenues as carefully as possible before contacting any of the authors and reviewers,” says Gamboa. When the dust had settled, it turned out that there was one author in the centre of the ring: Peter Chen, an engineer then at the National Pingtung University of Education (NPUE) in Taiwan, who was a co-author on practically all of the papers in question.

PASSWORD LOOPHOLE
Moon and Chen both exploited a feature of ScholarOne’s automated processes. When a reviewer is invited to read a paper, he or she is sent an e-mail with login information. If that communication goes to a fake e-mail account, the recipient can sign into the system under whatever name was initially submitted, with no additional identity verification. Jasper Simons, vice-president of product and market strategy for Thomson Reuters in Charlottesville, Virginia, says that ScholarOne is a respected peer-review system and that it is the responsibility of journals and their editorial teams to invite properly qualified reviewers for their papers.

ScholarOne is not the only publishing system with vulnerabilities. Editorial Manager, built by Aries Systems in North Andover, Massachusetts, is used by many societies and publishers, including Springer and PLOS. The American Association for the Advancement of Science in Washington DC uses a system developed in-house for its journals Science, Science Translational Medicine and Science Signaling, but its open-access offering, Science Advances, uses Editorial Manager. Elsevier, based in Amsterdam, uses a branded version of the same product, called the Elsevier Editorial System.

Usually, editors in the United States and Europe know the scientific community in those regions well enough to catch potential conflicts of interest between authors and reviewers. But Lindsay says that Western editors can find this harder with authors from Asia — “where often none of us knows the suggested reviewers”. In these cases, the journal insists on at least one independent reviewer, identified and invited by the editors.

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2:15PM 11/13/2014 – 10th Annual Personalized Medicine Conference at the Harvard Medical School, Boston

REAL TIME Coverage of this Conference by Dr. Aviva Lev-Ari, PhD, RN – Director and Founder of LEADERS in PHARMACEUTICAL BUSINESS INTELLIGENCE, Boston http://pharmaceuticalintelligence.com

 

 

2:15 p.m. Panel Discussion Reimbursement/Regulation

 

Reimbursement and Regulation

     Moderator:

Sheila D. Walcoff, J.D.
CEO and Founder, Goldbug Strategies, LLC

Panelists:

2. Catalina Lopez Correa, M.D., Ph.D.
Vice President/CSO, Scientific Affairs
Génome Québec

1. Michael Kolodziej, M.D.
National Medical Director for Oncology Strategies, Aetna

Clinical Utility Test is done cheap the drug used as therapeutics is $10,000 – without knowing if it will work or not

3. Bruce Quinn, M.D., Ph.D.
Senior Health Policy Specialist
Foley Hoag LLP

It is a whole ecosystem,

1. CMS – ACA

2. On diagnostics: clinical utility (six questions), clinical validity, analytical

$50 test kit from Abbott, 20,000 patients – $1 million market for test, Drug: $100,000 = $1 Billion for Pharma

Test coverage by Insurance:
  • If Patient sign Risks are known, Physician is educated, Patient is educated by Physician
  • Participation in Registry — test is covered
  • making information actionable to the Consumer

See more at: http://personalizedmedicine.partners.org/Education/Personalized-Medicine-Conference/Program.aspx#sthash.qGbGZXXf.dpuf

 

@HarvardPMConf

#PMConf

@SachsAssociates

@GenomeQuebec

@clopezcorrea

@Aetna (for Dr. Kolodziej)

 

@FoleyHoag (for Bruce Quinn)

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The Arnold Relman Challenge: US HealthCare Costs vs US HealthCare Outcomes

Reviewer and Curator: Larry H. Bernstein, MD, FCAP and

Curator: Aviva Lev-Ari, PhD, RN

 

 

 

About Arnold Relman


 

Arnold Relman (1923–2014) was Professor Emeritus of Medicine and Social Medicine at Harvard Medical School and a contributor of many articles and essays to The New York Review. Marcia Angell is a Senior Lecturer in Social Medicine at Harvard Medical School. Arnold Relman was her husband.

 

 SOURCE

http://www.nybooks.com/contributors/arnold-relman/

 

This is a posting of Relman’s just published review of the new publication  by Elizabeth H. Bradley and Lauren A. Taylor, in the prestigious Public Affairs (AUGUST 14, 2014 ISSUE)

The American Health Care Paradox: Why Spending More Is Getting Us Less

The US spends much more per person on medical care than any other country. And yet,

  • by commonly accepted measures of the quality of its national health system, it ranks only in the middle of the other advanced countries

belonging to the Organization for Economic Cooperation and Development (OECD).

Elizabeth Bradley and Lauren Taylor argue that

  • this “American health care paradox” is resolved when expenditures on other social services that undoubtedly contribute to improved national and personal health are taken into account.

These expenditures include support for such services as housing, education, maternal and child care, disease prevention, nutrition, environmental safety, and unemployment benefits. They also involve subsidies for the very poor, the disabled, and the elderly.

  • The US spends a much smaller percentage of its GDP on these programs than other OECD countries. Thus,

when these expenditures are added to what is spent for medical care, the total, expressed as a percentage of GDP, places our country in the middle of the other OECD countries.

That is consistent with the ranking of our health care system, and so the authors claim

  • the “paradox” is resolved.

To increase the quality of our health care system to the level now achieved by France, Germany, Switzerland, and Sweden,

  1. we would need not only to expand our investment in other social services, but also
  2. to practice what Bradley and Taylor call “a more holistic approach” to the medical care of each patient.

That means more attention to preventing illness and to modifying patients’ behavior in ways that promote health.

Their argument has intuitive appeal, made even stronger by the warm endorsement given by Dr. Harvey Fineberg, outgoing president of the Institute of Medicine (IOM) of the National Academy of Sciences, in the foreword he has written for the book, and by recent reports from committees of the IOM. It is generally agreed that

  • poor and disadvantaged populations, such as teenaged single mothers and their children, or
  • unemployed, uneducated, and ill-housed minorities,

suffer relatively poor health.

So it might seem entirely reasonable to conclude with the authors

  • that the answer to what ails our national health system lies in paying more attention to
  • social welfare programs, preventive measures, and education.

Relman dissatisfied:

Their argument is made more attractive by their clear prose and by their many helpful descriptions and historical explanations of US health care policy. Nevertheless, it does not persuade me, and
I don’t believe it will satisfy many critics who look closely at the issues.

In the first place, Bradley and Taylor pay insufficient attention to the great value Americans place on

  • the immediate diagnosis and treatment of personal illnesses and injuries, as compared with
  • public measures to enhance national health such as disease prevention and nutrition.

In the US, prompt medical care is given

  • far greater priority than improved public health, and
  • it commands much greater resources.

Research on personal medical care is also given a high priority, but  (political reality)

  • new large investments in social welfare programs are not a legislative or political necessity now or in the foreseeable future,
  • so long as conservative Republican opposition to governmental spending of this sort persists.

Moreover, the long-range economic benefits of social welfare and preventive measures are generally misunderstood. For example,

  • prevention of heart attacks in early life through exercise, better diet, and elimination of smoking would extend life into later decades.

That is certainly a desirable goal, but then the multiple

  • incurable disabilities of old age and the need for long-term care after retirement begin to increase total health costs.

Second, the evidence presented by Bradley and Taylor to support their claim of resolving the American health care “paradox” is not as strong as their rhetoric implies. This is well illustrated by their Figure 1.3, which shows

  • aggregate health care and social welfare spending in OECD countries for 2007, and

is supposed to demonstrate that when all costs are considered,

  • the US is no longer as inferior to European countries as many have claimed.

The figure shows that American total expenditures place it just about

  • in the middle of all the countries shown, in accord with the quality of its health care system.

Nevertheless, while total expenditures on health and social welfare in France, Sweden, Switzerland, and Germany exceed those in the US (which would be expected given their generally superior health systems), the figure shows

  • total expenditures for Canada, New Zealand, and Australia to be well below those in the US, even though
  • these countries are widely acknowledged to have better health systems than the US.
  • Similarly, total expenditures in Norway are roughly equal to those in the US, although the Norwegian national health system is generally recognized to be of much higher quality.

Their Table 4.1 (see below) also illustrates this lack of congruence between health care outcomes such as

  • infant mortality and life expectancy in selected countries and
  • their ranking in total expenditures (as shown in Figure 1.3).

In short, total expenditures (social welfare plus medical care) do not seem to be as consistently related to health outcomes as Bradley and Taylor would have us believe. But they are certainly correct in arguing that in general, more attention to welfare programs would improve the quality of life in the US.

American Health Care Paradox

American Health Care Paradox

My final reason for skepticism is the authors’ dependence on personal interviews with

  • a selected and limited number of sources for much of their original data on attitudes about health care.

Bradley, the senior author, is a professor of public health at Yale; Taylor was trained in public health and medical ethics. They would therefore be expected to use

  • the methods of descriptive social science in developing their arguments.

They state that they conducted interviews with “more than eighty health and social policy experts, researchers, practitioners, and consumers.” Anyone who has been involved in such interviews knows how variably the results can be interpreted. Bradley and Taylor were commendably diligent in recording and transcribing their interviews, but

  1. they took a relatively small sample, and
  2. much of it was limited to Scandinavian countries,
  3. which are very different from the US, for example
  • in their levels of taxation and their guarantees of medical care and public welfare generally.

As a result, the reader can never be quite sure how comprehensive and balanced a picture this book presents of the American health system, when compared with other OECD countries.

Nevertheless, it is hard to deny two basic and fairly obvious points the authors want to make.

First, inadequate social services in the US contribute to our poor national health.

Second, adding welfare expenditures to those of medical care does help to some extent to resolve the American “paradox” of high medical expenditures and relatively poor health outcomes. But the resolution

  • is not as complete or convincing as claimed, and
  • there is no evidence that expanding welfare programs,

as Bradley and Taylor argue,

  • would more effectively improve national health than directly reforming the payment and organization of medical services.

In fact, the evidence suggests the contrary. The US currently

  1. wastes vastly more resources on a dysfunctional medical care system than it would ever consider spending on social welfare, so
  2. the likelihood of bettering national health through major expansion of welfare programs is remote.

As difficult as it may be, trying to reform the medical system is a better bet;

  • this would free up resources that could be used to improve other social services.

In addition, most Americans will inevitably become ill or injured at some time in their lives, no matter how adequate the US social services, and for them at that time,

  • a good medical care system is essential. Therefore, it makes sense to consider

how reforming the payment and organization of medical care could reduce the heavy burden of

  • unnecessary waste, fraud, and bureaucratic overhead on our medical care system.

This looks like the best way to begin to resolve this book’s “paradox.”

There is widespread and growing recognition that the best way of improving the delivery of medical service and reducing its costs would be

  • a shift away from fee-for-service payment for medical care after it is received
  • to prepayment for comprehensive care.

The Affordable Care Act (ACA) attempts to move in this direction by establishing “accountable care organizations” that are paid

  1. small bonuses for bettering the treatment of Medicare patients (as defined by government guidelines). However,
  2. these organizations work mainly through private insurance plans, which, despite these intentions,
  3. still pay for the more expensive special procedures and services by fee-for-service.

The ACA is therefore not likely to control national health expenditures in the long term. Government actuaries and budget officers

  • predict that these expenditures will continue to rise at an unsustainable rate unless there is major reform.

To achieve better quality at lower costs, I believe we will have to progress beyond the ACA, and

  • the needed reforms will require more participation by the medical profession.

Physicians will have to join medical groups that accept a single payment for comprehensive care and

  • are willing to be paid mainly by salaries rather than the fees they bill and collect.

Although insurance companies will lobby hard to maintain their power, such a system does not need private insurance plans; it would be much better without them. Vast overhead expenditures would be saved if payment were to come from a single tax-supported agency. That’s why single-payer plans are getting increasing attention these days.

Recent changes in the medical care system have created forces that

  • both favor and inhibit the development of a single-payer arrangement.

Physicians who would formerly have started practicing solo or in small partnerships are rapidly becoming employees of large groups

  • in order to avoid the daunting economic risks of managing their own practices. Unfortunately,
  • most of these large groups are owned by hospitals that are primarily interested in furthering their own financial goals.

They use their physician employees to generate

  • more admissions and greater use of hospital-based procedures.

They want to defend the status quo and their own income, rather than press for reform.

An awakening interest in political affairs and a recent trend toward a preference for Democratic political candidates suggest that

  • the medical profession may soon wish to turn national health policy in a different direction.
    (this is a period of transition between generations)

No large-scale health reform is likely without broad support by physicians, so

  • their political awakening may be the most important factor in bringing about major change.

A united profession could influence the views of its patients, and this in turn could

  • influence legislators even more than the money of an army of lobbyists.
    (army of lobbyists is supported by an exhorbitant wealth disproportion unknown in history, or at least since reconstruction)

Legislators need votes most of all, and patients are the voters they need.
(assumes that patients are a homogeneous group; and thee is no difference between rural and municipalities)

Another recent change that may favor the arrival of single-payer health care is

  • the rapid increase in the number of women in active medical practice.

They will soon equal or outnumber men. Women physicians seem to be more interested in the

  • social services that are available in multispecialty medical group practices,
  • among them adequate child care and parental leaves.
  • They want to share practice responsibilities, and
  • they tend to have more liberal political views than most men.

This major demographic shift in the physician population, as well as its political movement toward more progressive policies, might put the profession in the forefront of health reform instead of the sidelines where it has usually been.

Without leadership by physicians, it is unlikely that we will see any major change in the system for payment and organization of medical care within the next decade or two. And

  1. without such change, the future of the American health system is bleak;
  2. either market forces or intrusive government regulations (or both)
  3. will control how physicians practice their profession.

Financial responsibility for health care coverage will increasingly fall on individuals, because

  • ‘neither government nor business employers will be able to afford the rising costs.

The greatest opportunities for reducing unnecessary costs and improving the quality of the American health system are to be found in

  • reforming the payment and organization of medical care
  • rather than in expanding social welfare programs.

Although these programs are of enormous importance for many reasons not only related to health, and well worth expanding, they cannot substitute for improving the effectiveness and efficiency of medical care for the sick and injured. That is where we are likely to see the most hopeful future development.

Epicrisis:

In my reading of Arnold Relman, I find that there is validity and unrealistic assumptions in his criticism.  It will take a generational change in the profession, which is currently avolving and making some of the changes he notes.

1. There is at least two generations of physicians who entered the profession in the post WWII era, when the Flexner model was in full force, and exemplified by William Osler, the Oslerian model..

Over a century ago, the Quaker merchant Johns Hopkins did more than provide in his will for the construction of a university, a hospital and a medical school.  He provided a vision of a unique university-based health center, one with a vital mission: to create a learning, training and caring environment where the quest for new knowledge would continuously yield more effective and compassionate care for all. Today, after a century of progress that even its founder could not have envisioned, the quest for new knowledge leading to better health care remains the defining mission of Johns Hopkins Medicine.

The original faculty of The Johns Hopkins University School of Medicine, including such pioneers of modern medicine as William H. Welch, William S. Halsted, William Osler and Howard A. Kelly, created a revolutionary new medical curriculum that integrated a rigorous program of basic science education with intensive clinical mentoring. With the opening of The Johns Hopkins Hospital in 1889, followed four years later by the School of Medicine, these founding physicians ushered in a new era in medical education marked by rigid entrance requirements for students, a vastly upgraded curriculum with emphasis on the scientific method, the incorporation of bedside teaching and laboratory research as part of the instruction, and integration of the School of Medicine with the Hospital through joint appointments. 

Notable faculty have included:  John Jacob Abel – Pharmacologist, John Shaw Billings – Civil War surgeon, pioneering leader in hygiene, Alfred Blalock – Developed field of cardiac surgery, Max Brödel – Acclaimed medical illustrator, William R. Brody – Radiologist, President of the Salk Institute, former President of Johns Hopkins UniversityBen Carson – Pediatric Neurosurgeon, awarded the Presidential Medal of Freedom, Denton Cooley – Renowned Cardiovascular surgeon, Harvey Cushing – Father of modern neurosurgery, Catherine Clarke Fenselau – Biochemist and mass spectrometrist,  William Halsted – Father of modern surgery, Leo Kanner – Father of child psychiatry, Albert L. Lehninger – Biochemist, Victor McKusick – Developed field of medical genetics, William Osler – Father of modern medicine, Wilder Penfield – Pioneer of epilepsy neurosurgery; developed the cortical homunculusPeter Pronovost – Anesthesiologst, MacArthur Fellow, Julie A. Freischlag, M.D., the director of the Department of Surgery

2. The large inroads in genetics, genomics and the Human Genome Project attests to the incredible growth in the knowledge base required from which physicians make decisions.  But despite the huge competition for entry, a shortage of primary care physicians, and a brain drain for less developed countries, the multicultural profession has had to adjust to a multicultural society into which it has to be integrated.  As much as a half century ago, candidates competed for entry on the basis of correlation with their undergraduate performance in organic chemistry.

3.  A half century ago, the poor could obtain emergency room care as a primary root of admission, which was likely late in the progression of the illness. This was not then, and is not now an acceptable system.

4. When Medicare came in, physicians accepted it as a reliable source for patients.  The same had to be true for hospitals.

5. Managed care began with the building of the Golden Gate Bridge, finished early, and supported by physicians employed by Henry Kaiser. This became a model taken seriously by Eastman Kodak and IBM.

6. It appears be be difficult to predict what will be in place a decade from now.  The Republican party is in default mode, and the Supreme Court has appointments that have not earned a lifetime appointment.

7.  I can’t see how the reorganizing of medicine, even with NPs and PAs can deal with the healthcare burden without attending to..

  • children in broken families
  • a substantial population in prison confinement
  • dealing with white collar corruption
  • supporting a minimum standard of living
  • an improvement in education at a very young age (with parental involvement)
  • a population that is more than 70% literate

8. There is a young physician population that has a dream and life style that is larger than the ALL MEDICINE and early to rise, late to bed than I have seen for so many years, and compassion has become important, as we don’t have all the answers, or all of the control.

 

 

 

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Larry H Bernstein, MD, FCAP, Curator

http://pharmaceuticalintelligence/7/8/2014/Proteins and cellular adaptation to stress

There are two recent articles that are, if not interesting, possibly important in the direction of cellular regulation, adaptation, and decline.  One deals with apoptosis, or cell death, which is synchronized with recovery of membrane and protein breakdown for reuse in synthesis and maintenance.  The other is a new perspective to Alzhemier’s Disease, for which there is no effective pharmacotherapy. In both cases, the stresses of the cell are critical to the responce to the environment.  This is not just about the classical transcriptomics story. This is a perfect followup to the just posted research on the regulatory role of a small RNA that is related to, but distinct from silencing RNA, and also the revelations about lncRNA.

Protein Helps Cells Adapt—or Die

Scientists show how cell stress both prevents and promotes cell suicide in a study that’s equally divisive.

By Ruth Williams | July 3, 2014

A cellular stress pathway called the unfolded-protein-response (UPR) both activates and degrades death receptor 5 protein (DR5), which can promote or prevent cell suicide, according to a paper published in Science today (July 3). The theory is that initial stress blocks cell suicide, or apoptosis, to give the cell a chance to adapt, but that if the stress persists, it eventually triggers apoptosis.

“This work has made the most beautiful simplification of all this big complex mess. Basically, they identified and pinpointed the specific protein involved in the switching decision and explain how the decision is made,” said Alexei Korennykh, a professor of molecular biology at Princeton University, who was not involved in the work.

But Randal Kaufman of the Sanford-Burnham Medical Research Institute in La Jolla, California, was not impressed. He questioned the physiological relevance of the experiments supporting the authors’ main conclusions about this key cellular process.

Protein folding in a cell takes place largely in the endoplasmic reticulum (ER), but if the process goes awry, unfolded proteins accumulate, stressing the ER. This triggers the UPR, which shuts down translation, degrades unfolded proteins, and increases production of protein-folding machinery. If ER stress is not resolved, however, the UPR can also induce apoptosis.

Two main factors control the UPR—IRE1a and PERK. IRE1a promotes cell survival by activating the transcription factor XBP1, which drives expression of cell-survival genes. PERK, on the other hand, activates a transcription factor called CHOP, which in turn drives expression of the proapoptotic factor DR5.

Peter Walter of the University of California, San Francisco, and his colleagues have now confirmed that CHOP activates DR5, showing that it is a cell-autonomous process. But they have also found that IRE1a suppresses DR5, directly degrading its mRNA through a process called regulated IRE1a-dependent degradation (RIDD). Inhibition of IRE1a in a human cancer cell line undergoing ER stress both prevented DR5 mRNA decay and increased apoptosis.

However, in an e-mail to The Scientist, Kaufman expressed concern that “the significance of RIDD has not been demonstrated in a physiologically-relevant context.”

Walter insisted that the evidence for RIDD’s existence is “crystal clear.” His only concession was that “the effects aren’t 100 percent,” he said, because “RIDD degrades mRNA by a few-fold,” making it difficult to measure.

This RIDD debate aside, the researchers have also sparked a rumpus with their finding that IRE1a expression switches off just 24 hours after ER stress initiation, leaving PERK to drive the cell toward apoptosis. “We and others have evidence that suggests another model,” said Scott Oakes, a professor of pathology at the University of California, San Francisco, “which is that both PERK and IRE1a under high stress will send out death signals.”

Whether IRE1a promotes or inhibits apoptosis under extreme stress “is controversial,” said Ira Tabas, a professor at Columbia University in New York City. But it’s essential that scientists figure it out. Cell death from ER stress is a pathological process in many major diseases, Tabas said, and there are IRE1a inhibitors in pharmaceutical development. “It is very important because under high stress you have two different views here,” said Oakes. “One is that you want to keep IRE1a on, the other is that you want to shut it off.”

Because ER stress is central to many diseases, “a lot of people are passionate about it,” said Tabas, explaining the polemic views. “Who’s right? . . . I think it depends on the context in which the experiments are done—one pathway may be important in some settings, and another pathway may be important in different settings,” he suggested. What might help to resolve the issues, he said, will be “in vivo causation studies using actual disease models.”

Researchers will continue to debate. So, said Walter, “we’ll have to see what holds-up five years from now.”

M. Lu et al., “Opposing unfolded-protein-response signals converge on death receptor 5 to control apoptosis,” Science, 345:98-101, 2014.

Tags stress responseprotein foldingdisease/medicinecell & molecular biology and apoptosis

 

Protein May Hold the Key to Who Gets Alzheimer’s

 

By PAM BELLUCK     MARCH 19, 2014

 

It is one of the big scientific mysteries of Alzheimer’s disease: Why do some people whose brains accumulate the plaques and tangles so strongly associated with Alzheimer’s not develop the disease?

 

Now, a series of studies by Harvard scientists suggests a possible answer, one that could lead to new treatments if confirmed by other research.

 

The memory and thinking problems of Alzheimer’s disease and other dementias, which affect an estimated seven million Americans, may be related to a failure in the brain’s stress response system, the new research suggests. If this system is working well, it can protect the brain from abnormal Alzheimer’s proteins; if it gets derailed, critical areas of the brain start degenerating.

“This is an extremely important study,” said Li-Huei Tsai, director of the Picower Institute for Learning and Memory at the Massachusetts Institute of Technology, who was not involved in the research but wrote a commentary accompanying the study. “This is the first study that is really starting to provide a plausible pathway to explain why some people are more vulnerable to Alzheimer’s than other people.”

An image of tau tangles in the brain, often a hallmark of Alzheimer’s disease.

An image of tau tangles in the brain, often a hallmark of Alzheimer’s disease.

 

 

 

The research, published on Wednesday in the journal Nature, focuses on a protein previously thought to act mostly in the brains of developing fetuses. The scientists found that the protein also appears to protect neurons in healthy older people from aging-related stresses. But in people with Alzheimer’s and other dementias, the protein is sharply depleted in key brain regions.

Experts said if other scientists could replicate and expand upon the findings, the role of the protein, called REST, could spur development of new drugs for dementia, which has so far been virtually impossible to treat. But they cautioned that much more needed to be determined, including whether the decline of REST was a cause, or an effect, of brain deterioration, and whether it was specific enough to neurological diseases that it could lead to effective therapies.

“You’re going to see a lot of papers now following up on it,” said Dr. Eric M. Reiman, executive director of the Banner Alzheimer’s Institute in Phoenix, who was not involved in the study. “While it’s a preliminary finding, it raises an avenue that hasn’t been considered before. And if this provides a handle on which to understand normal brain aging, that will be great, too.”

REST, a regulator that switches off certain genes, is primarily known to keep fetal neurons in an immature state until they develop to perform brain functions, said Dr. Bruce A. Yankner, a professor of genetics at Harvard Medical School and the lead author of the new study. By the time babies are born, REST becomes inactive, he said, except in some areas outside the brain like the colon, where it seems to suppress cancer.

While investigating how different genes in the brain change as people age, Dr. Yankner’s team was startled to find that REST was the most active gene regulator in older brains. The researchers have found that this protein, normally active in fetuses, may also protect the neurons in older people.  It is not yet possible to measure the levels of this protein that is a gene regulator called REST, in living people.

“Why should a fetal gene be coming on in an aging brain?” he wondered. He hypothesized that it was because in aging, as in birth, brains encounter great stress, threatening neurons that cannot regenerate if harmed.

His team discovered that REST appears to switch off genes that promote cell death, protecting neurons from normal aging processes like energy decrease, inflammation and oxidative stress.

Analyzing brains from brain banks and dementia studies, the researchers found that brains of young adults ages 20 to 35 contained little REST, while healthy adults between the ages of 73 and 106 had plenty. REST levels grew the older people got, so long as they did not develop dementia, suggesting that REST is related to longevity.

But in people with Alzheimer’s, mild cognitive impairment, frontotemporal dementia and Lewy body dementia, the brain areas affected by these diseases contained much less REST than healthy brains.

This was true only in people who actually had memory and thinking problems. People who remained cognitively healthy, but whose brains had the same accumulation of amyloid plaques and tau tangles as people with Alzheimer’s, had three times more REST than those suffering Alzheimer’s symptoms. About a third of people who have such plaques will not develop Alzheimer’s symptoms, studies show.

REST levels dropped as symptoms worsened, so people with mild cognitive impairment had more REST than Alzheimer’s patients. And only key brain regions were affected. In Alzheimer’s, REST steeply declined in the prefrontal cortex and hippocampus, areas critical to learning, memory and planning. Other areas of the brain not involved in Alzheimer’s showed no REST drop-off.

It is not yet possible to analyze REST levels in the brains of living people, and several Alzheimer’s experts said that fact limited what the new research could prove.

John Hardy, an Alzheimer’s researcher at University College London, cautioned in an email that information from post-mortem brains could not prove that a decline in REST caused dementia because death might produce unrelated damage to brain cells.

To investigate further, the team conducted what both Dr. Tsai and Dr. Reiman called a “tour de force” of research, examining REST in mice, roundworms and cells in the lab.

“We wanted to make sure the story was right,” Dr. Yankner said. “It was difficult to believe at first, to be honest with you.”

Especially persuasive was that mice genetically engineered to lack REST lost neurons as they aged in brain areas afflicted in Alzheimer’s.

Dr. Yankner said REST appeared to work by traveling to a neuron’s nucleus when the brain was stressed. In dementia, though, REST somehow gets diverted, traveling with toxic dementia-related proteins to another part of the neuron where it is eventually destroyed.

Experts said the research, while intriguing, left many unanswered questions. Bradley Wise of the National Institute on Aging’s neuroscience division, which helped finance the studies, said REST’s role needed further clarification. “I don’t think you can really say if it’s a cause of Alzheimer’s or a consequence of Alzheimer’s” yet, he said.

Dr. Samuel E. Gandy, an Alzheimer’s researcher at Mount Sinai Medical Center, wondered if REST figured only in neurodegenerative diseases or in other diseases, too, which could make it difficult to use REST to develop specific treatments or diagnostic tests for dementia.

“My ambivalence is, is this really a way that advances our understanding of the disease or does this just tell us this is even more complicated than we thought?” he said.

Dr. Yankner’s team is looking at REST in other neurological diseases, like Parkinson’s. He also has thoughts about a potential treatment, lithium, which he said appears to stimulate REST function, and is considered relatively safe.

But he and other experts said it was too early. “I would hesitate to start rushing into lithium treatment” unless rigorous studies showed that it could forestall dementia, said Dr. John C. Morris, an Alzheimer’s researcher at Washington University in St. Louis.

Still, Dr. Morris said, the REST research the team conducted so far is “very well done, and certainly helps support this idea that we’ve all tried to understand about why Alzheimer’s is age-associated and why, while amyloid is necessary for the development of Alzheimer’s disease, it certainly is not sufficient.”

He added, “There have to be some other processes and triggers that result in Alzheimer’s.”

Correction: March 19, 2014 
Because of an editing error, an earlier version of this article misstated the gender of Dr. Li-Huei Tsai. Dr. Tsai is a woman.

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