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    Dr. Marcinko is originally from Loyola University MD, Temple University in Philadelphia and the Milton S. Hershey Medical Center in PA; as well as Oglethorpe University and Emory University in Georgia, the Atlanta Hospital & Medical Center; Kellogg-Keller Graduate School of Business and Management in Chicago, and the Aachen City University Hospital, Koln-Germany. He became one of the most innovative global thought leaders in medical business entrepreneurship today by leveraging and adding value with strategies to grow revenues and EBITDA while reducing non-essential expenditures and improving dated operational in-efficiencies.

    Professor David Marcinko was a board certified surgical fellow, hospital medical staff President, public and population health advocate, and Chief Executive & Education Officer with more than 425 published papers; 5,150 op-ed pieces and over 135+ domestic / international presentations to his credit; including the top ten [10] biggest drug, DME and pharmaceutical companies and financial services firms in the nation. He is also a best-selling Amazon author with 30 published academic text books in four languages [National Institute of Health, Library of Congress and Library of Medicine].

    Dr. David E. Marcinko is past Editor-in-Chief of the prestigious “Journal of Health Care Finance”, and a former Certified Financial Planner® who was named “Health Economist of the Year” in 2010. He is a Federal and State court approved expert witness featured in hundreds of peer reviewed medical, business, economics trade journals and publications [AMA, ADA, APMA, AAOS, Physicians Practice, Investment Advisor, Physician’s Money Digest and MD News] etc.

    Later, Dr. Marcinko was a vital and recruited BOD  member of several innovative companies like Physicians Nexus, First Global Financial Advisors and the Physician Services Group Inc; as well as mentor and coach for Deloitte-Touche and other start-up firms in Silicon Valley, CA.

    As a state licensed life, P&C and health insurance agent; and dual SEC registered investment advisor and representative, Marcinko was Founding Dean of the fiduciary and niche focused CERTIFIED MEDICAL PLANNER® chartered professional designation education program; as well as Chief Editor of the three print format HEALTH DICTIONARY SERIES® and online Wiki Project.

    Dr. David E. Marcinko’s professional memberships included: ASHE, AHIMA, ACHE, ACME, ACPE, MGMA, FMMA, FPA and HIMSS. He was a MSFT Beta tester, Google Scholar, “H” Index favorite and one of LinkedIn’s “Top Cited Voices”.

    Marcinko is “ex-officio” and R&D Scholar-on-Sabbatical for iMBA, Inc. who was recently appointed to the MedBlob® [military encrypted medical data warehouse and health information exchange] Advisory Board.

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2021 Prescription Drug Payment Model from HHS

Administration Announces Prescription Drug Payment Model
***
By staff reporters
***
HHS Secretary Alex Azar has announced a drug payment model through the Center for Medicare and Medicaid Innovation at the Centers for Medicare & Medicaid Services that will lower Medicare Part B payments for certain drugs to the lowest price for similar countries and save American taxpayers and beneficiaries more than $85 billion over seven years.
***
***
Starting in January, the model, known as the Most Favored Nation (MFN) Model, will test an innovative way for Medicare to pay no more for high cost, physician-administered Medicare Part B drugs than the lowest price charged in other similar countries.
***
Following the President’s recent Executive Orders to lower drug prices and improve access to life-saving medications, the MFN Model will protect current beneficiary access to Medicare Part B drugs, make them more affordable, and address the disparity of drug costs between the U.S. and other countries.
***
Source: CMS [11/20/20]

CMS Value Based Purchasing for Drugs

CMS Proposed Rule Supports Value-Based Purchasing for Drugs

Courtesy: www.CertifiedMedicalPlanner.org

On June 19, 2020 the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule regarding Medicaid Drug Rebate Program (MDRP) regulations, with the aim of lowering drug prices, increasing patient access, and encouraging innovation in the insurance and pharmaceutical industries.

This proposal is consistent with the Trump Administration’s Blueprint to Lower Drug Prices (Blueprint) released in May 2018, in which the administration highlighted its goal to “avoid excessive pricing by relying more on value-based pricing by expanding outcome-based payments in Medicare and Medicaid” and to “speed access to and lower the cost of new drugs by clarifying policies for sharing information between insurers and drug makers.”

***

***

The proposed rule seeks to accomplish the Blueprint’s goals by reducing regulatory barriers that have previously prevented commercial plans and states from entering into value-based purchasing (VBP) arrangements with drug manufacturers.

Colleagues from Health Capital Consultants, LLC; explain.

ESSAY: DRUGS

Assessment: Your thoughts and comments are appreciated.

BUSINESS, FINANCE, INVESTING AND INSURANCE TEXTS FOR DOCTORS:

1 – https://lnkd.in/ebWtzGg

2 – https://lnkd.in/ezkQMfR

3 – https://lnkd.in/ewJPTJs

THANK YOU

***

Insurers, PBMs and Specialty Pharmacies Today

CIRCA: 2019 Vertical Business Relationships

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Conclusion: Your thoughts are appreciated.

Product DetailsProduct DetailsProduct Details

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Here’s Why Drug-Distribution and Pharmacy Stocks are Bargains Now

On Drug-Distribution and Pharmacy Stocks

Vitaliy Katsenelson, CFA
  Student of Life

These pharnacy stocks are good businesses. In general they have solid balance sheets, above-average returns on capital, and they generate a lot of cash, which is used to pay dividends and buy back stock.

But, these defensive features have not mattered much lately, as we are entering the 10th year of uninterrupted economic expansion.

Accordingly, these companies are significantly undervalued. How under valued? Let’s answer that question by examining two stocks in our portfolio in closer detail.

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Prescription Pill Bottles

***

Here’s Why Drug-Distribution and Pharmacy Stocks are Bargains Now

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Comprehensive Financial Planning Strategies for Doctors and Advisors: Best Practices from Leading Consultants and Certified Medical Planners™

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Prescription Drug Uses and Costs

Seclected Facts: 2015-2016

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Product DetailsProduct Details

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Level 5 Drug Setting and Price Trends

FY:  2009 – 2017

By www. MCOL.com

******

Invite Dr. Marcinko

***

Product DetailsProduct Details

***

 

About the Opioid Crisis

And, Drug Distributors

[By Vitaliy Katsenelson CFA]

I don’t know anyone personally who has been affected by the opioid epidemic in the US. And I truly hope I never will. I don’t know if I would be able to maintain objectivity in my analysis of drug distributors and their involvement in this epidemic if I had experienced getting a call at night informing me that my loved one had died from a drug overdose. Drug overdoses killed 70,237 Americans in 2017. Of these deaths, 47,600 (67.8%) involved opioids and 17,000 involved prescription opioids (24% of total overdose deaths). Legally prescribed opioids are killing 47 of us every day.

How did we get here?

According to the National Institute on Drug Abuse: “In the late 1990s, pharmaceutical companies reassured the medical community that patients would not become addicted to prescription opioid pain relievers, and healthcare providers began to prescribe them at greater rates. This subsequently led to widespread diversion and misuse of these medications before it became clear that these medications could indeed be highly addictive.”

Today pharma distributors are used as scapegoats for the opioid epidemic – not because they are guilty but because they have money and they are “drug distributors.” They are dragged through the same mud as the tobacco companies and British Petroleum (after it spilled millions of gallons of oil in the Gulf of Mexico). Despite negative headlines, we own drug distributors.

Here is why:

They distribute legally prescribed medicine to pharmacies that are approved by several government agencies, including the DEA. Doctors write scripts; pharma distributors order medicine from pharma manufacturers and deliver them to pharmacies. The sad truth about the opioid epidemic is that 21-29% of patients who were prescribed them for chronic pain misused them, and 8-12% of those who received an opioid prescription developed an opioid use disorder.
However, just as truck drivers cannot be held liable for delivering cigarettes to convenience stores, pharma distributors are not manufacturers of drugs and cannot be held liable for the addictive properties of the drugs they distribute or the fact that doctors overprescribe them and patients misuse them.
Also, the DEA should be responsible for limiting the illegal use of opioids. That is its job – DEA stands for Drug Enforcement Agency. It has legal and enforcement resources that distributors lack. And it has a lot more data and tools. Drug distributors do their part and provide data to the ARCOS database that DEA manages.
***
drugs
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However, each individual distributor has data only for the drugs it distributes, while DEA has data (which it doesn’t share with distributors) for all opioid sales to pharmacies. The DEA is in a much better position to spot suspicious activity in orders than distributors. The DEA controls how much legal opioid is manufactured in the US every year and has been increasing quotas of opioids produced.
Opioids constitute only a very small percentage of the $450 billion in drugs distributed in the US, and thus incentives for distributors to overdistribute opioids are very limited. Though lawyers and the media keep saying that distributors are some of the largest companies in the S&P 500 by sales, they forget to mention that distributors operate on razor thin margins of less than 2%. Comparing the distributors (not even the makers) of legal medicine, that helps millions of people cope with excruciating pain, to cigarette companies that have a 40% pretax profit margin on a product that doesn’t have a societal benefit, and is almost guaranteed to cause cancer if you use it long enough, creates awesome headlines but has little substance.
  • What if DEA was the one distributing all the opioid drugs to pharmacies instead of McKesson, Cardinal Health, and Amerisource Bergen?
  • Would fewer people get addicted to opioids?
  • Would opioids be less accessible? Remember, DEA sets the production targets every year.
Maybe DEA would catch a few bad actors sooner – it has more data than distributors and a specific skillset and mindset aimed at catching criminals.
But in the big scheme of things, even if DEA distributed opioids nothing would really change. Doctors would still prescribe them; some patients would still get addicted to them … and so on. Distributors will likely settle lawsuits for two reasons:
First, McKesson already settled with the FDA for $150 million for “failure to report suspicious orders of pharmaceutical drugs.”
***
Second, McKesson and other drug distributors don’t want to be involved in costly and protracted litigation. We don’t know how much the settlement will be, but it is very unlikely to be in the hundreds of billions of dollars and likely (see reasons above) to be hundreds of millions or a few billion dollars.
***
Assessment
Today McKessonʻs market capitalization is $25 billion. We think the company is worth at least $50 billion (at 15 times earnings), thus there is a $25 billion of margin of safety. If the lawsuit costs the company less than $25 billion, McKesson will be a profitable investment; if not, then the market is right and we are wrong.

Conclusion

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***

Risk Management, Liability Insurance, and Asset Protection Strategies for Doctors and Advisors: Best Practices from Leading Consultants and Certified Medical Planners™Comprehensive Financial Planning Strategies for Doctors and Advisors: Best Practices from Leading Consultants and Certified Medical Planners™

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The Most Prescribed Drugs Today

In the USA

By http://www.MCOL.com

***

***

Conclusion

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Contact: MarcinkoAdvisors@msn.com

***

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The Regulatory Capture of American Medicine by the Drug and Alcohol Testing, Assessment and Treatment Industry

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Regulatory Capture?

Langan MD

[By Michael Lawrence Langan MD]

Regulatory capture is a form of government failure that occurs when a regulatory agency created to act in the public interest, instead advances the commercial or political concerns of special interest groups that dominate the industry or sector it is charged with regulating and introduced in an article by George J. Stigler in 1971 entitled The Theory of Economic Regulation. The main idea of the article can be summarized in Stigler’s (1971: 3) affirmation that:

“…as a rule, regulation is acquired by the industry and is designed and operated primarily for its benefits.”

The Regulatory Capture of American Medicine by the Drug and Alcohol Testing, Assessment and Treatment Industry

Conclusion

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Risk Management, Liability Insurance, and Asset Protection Strategies for Doctors and Advisors: Best Practices from Leading Consultants and Certified Medical Planners™

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On Rx Patient Non-Adherence

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By http://www.MCOL.com

A Picture of Poor Health and Opportunity for Retail Pharmacy and Pharmacy Benefits Managers [PBMs] 

***

drugs

***’

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***

Conclusion

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***

Peri-Operative MEs and ADEs

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One in Twenty [1/20]

By http://www.MCOL.com

***

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***

Conclusion

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[Mike Stahl PhD MBA] *** [Foreword Dr.Mata MD CIS] *** [Dr. Getzen PhD]

***

National Health Expenditure Growth

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A Report from the Office of the Actuary

Source: Centers for Medicare & Medicaid Services

According to the Centers for Medicare & Medicaid Services (CMS) Office of the Actuary, overall national health expenditures grew at an annual rate of 3.7 percent in 2012, marking the fourth consecutive year of low growth. Health spending as a share of gross domestic product fell slightly from 17.3 percent in 2011 to 17.2 percent in 2012.

Private Insurance

Private health insurance spending growth remained low. Private health insurance spending continued to grow at a low rate, increasing 3.2 percent in 2012 compared to 3.4 percent growth in 2011. Medicare spending growth continued to be low. Despite a large uptick in Medicare enrollment, Medicare spending growth slowed slightly in 2012, increasing by 4.8 percent compared to 5.0 percent growth in 2011.

The Totals for MC/MD

Total Medicare spending per enrollee grew by only 0.7 percent in 2012. Medicaid spending continued to grow at a historically low rate. Total Medicaid spending grew 3.3 percent in 2012. While an increase over 2011, this increase still represents historically low overall growth rates tied to improved economic conditions, as well as efforts by states to control costs.

Rx Drugs

Prescription drug spending growth was low. Retail prescription drug spending slowed in 2012, growing only 0.4 percent as the result of numerous drugs losing their patent protection, leading to increased sales of lower-cost generics. Nursing home spending growth slowed.

Pharma

Assessment

Spending for freestanding nursing care facilities and continuing care retirement communities increased by only 1.6 percent in 2012, down from 4.3 percent growth in 2011, due to a one-time Medicare rate adjustment for skilled nursing facilities.

Conclusion

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Got Drugs?

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www.DEA.Gov

The Concept

Turn in your used or expired medication for safe disposal on September 25th.

Assessment

This novel program is actually available, anytime.

Conclusion

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Medical Risk Management: http://www.jbpub.com/catalog/9780763733421

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Physician Advisors: www.CertifiedMedicalPlanner.org

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Appreciating the Financial Toll Drug Use Has on Us

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The Cost of Drug Abuse

What does it cost to send a drug addict to jail? Far more than it needs to as demonstrated by this infographic.

War on Drugs

Thanks in part to the War on Drugs, more than half of the inmates in the federal prisons are there because of drug-related offenses.

It’s a staggering statistic, one that helps explain the explosive growth of the prison system over the past thirty years, as officials struggle to keep up with the influx of inmates convicted of, in many cases, minor drug possession.

Source: www.clarityway.com via  www.fastcodesign.com

Conclusion

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Health Dictionary Series: http://www.springerpub.com/Search/marcinko

Practice Management: http://www.springerpub.com/product/9780826105752

Physician Financial Planning: http://www.jbpub.com/catalog/0763745790

Medical Risk Management: http://www.jbpub.com/catalog/9780763733421

Hospitals: http://www.crcpress.com/product/isbn/9781439879900

Physician Advisors: www.CertifiedMedicalPlanner.org

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Our Rx Drugged Culture

America’s Most Prescribed Psychiatric Drugs

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Conclusion      

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The Prescription [Rx] Drugs Most Marketed to Doctors

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An Infographic

This ME-P comes to us from Appature, a Seattle based company that provides a cloud based healthcare marketing tool.

Upon submission of this infographic, the folks at Appature had the following to say:

Appature Inc, a Seattle-based software company that makes marketing tools for the healthcare industry, just launched its first infographic about Prescriptions Most Marketed to Doctors in the healthcare industry! Our infographic breaks down the ins and outs of which prescriptions are most marketed to doctors, to which prescriptions have the greatest sales ($5.3 Billion!) and even patient sentiments regarding a doctor’s prescribing habits. By reading this infographic, we hope that readers will get a little peek inside the intricate inner-workings of the infamous pharmaceutical industry! As TIME magazine highlights, “…the pharmaceutical industry is – and has been for years – the most profitable of all businesses in the U .S.”

Conclusion

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FINANCE: Financial Planning for Physicians and Advisors
INSURANCE: Risk Management and Insurance Strategies for Physicians and Advisors


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Doctors on Drugs?

Sponsored Medications Increase MDs Bottom Line

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Increasing in costs each year, prescription pills are one of the most profitable and dominating industries in the nation, with annual sales in the hundreds of billions. Prescribed medications constitute a significant bulk of work that medical coders must transcribe.

Shockingly, the prescription pill industry has questionable practices to increase their bottom line, and in turn, increase coding workload through unnecessary prescriptions.

Though pharmaceutical companies have long-earned a reputation for wooing doctors with gifts, bribes, and incentives, it was only revealed in recent years that they’ve also been paying doctors huge sums of money to promote certain products – and doctors are taking up these offers. These pre-selected medications are not only violating a conflict of interest, they can be largely responsible for increases in patient and insurance costs: a doctor may feel obligated to prescribe an expensive “sponsored” medication over a cheaper alternative.

This in turn, is reflected on the overall rising cost of healthcare, which unfortunately, is exactly what the doctor ordered.

Source: Medical Billing and Coding

Conclusion                

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Practice Management: http://www.springerpub.com/product/9780826105752

Physician Financial Planning: http://www.jbpub.com/catalog/0763745790

Medical Risk Management: http://www.jbpub.com/catalog/9780763733421

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Pfizer’s Latest Twist on ‘Pay for Delay’

Protecting Brand-Named Drugs

By Marian Wang
ProPublica, November, 14th, 2011, 2:41 pm

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Pharmaceutical companies have sought for years to protect their expensive brand-name drugs by paying generic rivals [1] handsome sums of money to put off efforts to introduce cheaper, generic alternatives that could steal market share.

Pay for Delay

The controversial practice, known as “pay for delay,” occurs as part of patent litigation settlements and typically buys a brand-name drug company more time to sell its blockbuster drug exclusively until its patent on the drug expires. Federal Trade Commission regulators have said the practice costs consumers an estimated $3.5 billion each year [2], and have pushed for a ban.

But now it appears the drug company Pfizer is adding yet another twist to its efforts to delay generic competitors. As The New York Times reports, the company seems to have struck a deal with certain pharmacy benefit managers — the middlemen in the pharmaceutical industry — to block generic versions [3] of Lipitor.

The Block Buster

Lipitor, Pfizer’s blockbuster cholesterol-lowering drug, is among the world’s best-selling pharmaceuticals, and this isn’t Pfizer’s first attempt to protect it.

In 2008, the company settled patent litigation [4] with Ranbaxy, an Indian generic manufacturer, striking a deal that guaranteed that Pfizer would not have to face challenges [5] from Ranbaxy’s generic version of Lipitor until the end of November 2011. Pfizer granted Ranbaxy some incentives [6] as part of the bargain but said it made no payments. Nonetheless, a group of pharmacies filed suit [7] against Pfizer and Ranbaxy last week over the deal, calling it “an extraordinary ripoff” and alleging price-fixing between the two companies.

Big Discounts

Now that it’s November 2011, Ranbaxy and other drugmakers are gearing up to offer cheaper versions of Lipitor. As The Times reports [3], Pfizer has tried to counter this competition by offering big discounts on Lipitor to the middlemen that process prescriptions [8] for pharmacies and other buyers, giving them discounts in exchange for having them block generic versions of Lipitor for another six months. Here’s The Times:

Many drugstores are being asked to block prescriptions for a generic version of Pfizer’s Lipitor starting Dec. 1, when the company loses its patent for the blockbuster cholesterol drug and generic competition begins.

Medco Health Solutions, among the nation’s largest pharmacy benefit managers, is one of the companies issuing instructions, seeking to have pharmacists keep filling prescriptions with the more expensive Lipitor for six months.

See some of those instructions [9] sent to pharmacies by the pharma middlemen. The documents were released by Pharmacists United for Truth and Transparency, a group of independent pharmacists. (We first noticed them posted at the blog Pharmalot [10].)

According to the group, Pfizer’s plan would mean that customers at the pharmacies serviced by these middlemen would receive Lipitor even when they’ve been prescribed a generic version. Because Lipitor co-pays would also be reduced to the level of generic co-pays, customers might not notice, but employers and Medicare Part D would pay the same amount as before, despite the availability of a cheaper alternative.

Assessment

A Pfizer spokesman gave The Times a statement saying that the company was committed to ensuring that customers had access to Lipitor but declined to answer additional questions. We’ve also asked Pfizer for comment and will update when we hear back.

Conclusion

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On the New Pot Health Policy in NJ?

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It’s Medicinal – Man!

By Staff Reporters

Did you know that in January 2010, New Jersey became the 14th state in the nation to legalize marijuana use for certain chronic illnesses?

Other states where the use of medical marijuana is permitted include Alaska, California, Colorado, Hawaii, Maine, Michigan, Montana, Nevada, New Mexico, Oregon, Rhode Island, Vermont, and Washington; around a dozen more states are weighing pending bills.

Jersey is Toughest State

The New Jersey law is the most restrictive in the nation and authorizes prescribed marijuana for only a handful of chronic illnesses, such as multiple sclerosis, cancer, glaucoma, epilepsy, Crohn’s disease, AIDS, muscular dystrophy and Lou Gehrig’s disease. Unlike other states, physicians in New Jersey will not be able to prescribe medical marijuana for anxiety, headaches, or chronic pain.

Dispensaries

According to reports, the state of New Jersey plans to authorize six dispensaries, and patients will receive identification cards authorizing them to purchase the drug. They will not be able to grow their own marijuana or use it in public, however. And, individuals without a prescription will still be subject to criminal prosecution if caught in possession of marijuana.

http://www.hcplive.com/oncology/articles/Marijuana?utm_source=Listrak&utm_medium=Email&utm_term=%2foncology%2farticles%2fMarijuana&utm_campaign=Legalizing+Medical+Marijuana

Assessment

Do you support the use of medical marijuana? If you are a doctor that lives in a state where medical marijuana is legalized, have you prescribed it to any patients? If you live in a state where medical marijuana is not legalized, do you want it to be? What about you patients, out there?

Conclusion

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Beware the Faux Medical Journals

When is a “Journal” … not a Journal?

By Dr. David Edward Marcinko; MBA, CMP™

Publisher-in-Chiefdem23

Allow me to begin this post by making the unusual disclosure that I was the Editor-in-Chief of a print guide in healthcare finance and economics [aka periodical or journal].

Formally, the title was: Healthcare Organizations [Financial Management Strategies]. At 2 volumes, and more than 1,200 pages, it was quite a job to update it quarterly. And, with more than two dozen contributing authors, it was a labor of love indeed. Alas … no more!

ho-journal9

Varying Levels of Credibility

Now, we doctors know that medical journals are not all alike. There are different levels of “credibility.” Some are peer-reviewed, others not. Some are trade magazines. Frankly, some “real” journals are better, and more respected than others. Some entrenched journals are in decline, while other emerging journals are leading-edge in the health 2.0 space. Still others, like the formerly esteemed Journal of the American Medical Association [JAMA], have been accused of outright censorship.

Link: https://healthcarefinancials.wordpress.com/2009/04/02/is-jama-censoring-physician-dissent/

Adventures

Of course, doctors also know that pharmaceutical companies routinely offer us reprints of articles from medical journals that are favorable to their products. But, news of a Merck-sponsored publication for doctors in Australia has come to light in a personal injury lawsuit over Vioxx. It raised more than a few eyebrows in international medical publishing circles. It may have even crossed the line of journalistic, not to mention medical, ethics.

Read: Merck Paid for Medical ‘Journal’ Without Disclosure; by Natasha Singer, May 13, 2009.

Link: http://www.nytimes.com/2009/05/14/business/14vioxxside.html?_r=1&adxnnl=1&adxnnlx=1242313549-xaAEwW4MCd7pJh9OdgWdUQ

Mis-Adverntures

Tracy Staton wrote more about these mis-adventures in a story, dated May 14, 2009, in FiercePharma.

Analysis and Apology

Analysis in the Pipeline: http://seekingalpha.com/article/136942-merck-and-elsevier-cross-the-line-in-joint-medical-journal?source=yahoo

Libology Mea Culpa: http://www.libology.com/blog/tag/excerpta-medica

Assessment

Perhaps; Merck ought to read our Medical-Executive Post on health journalists?

Link: https://healthcarefinancials.wordpress.com/2009/03/17/battered-health-journalists

Or, our Medical-Executive Post on medical experts, reporters and journalists?

Link: https://healthcarefinancials.wordpress.com/2009/03/09/healthcare-experts-versus-health-journalists

Conclusion

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Disclosures Lacking in Drug Studies

New – Dark Alley – Report on Drug Studies

Staff Reportersdark-alley

A report in Bloomberg News, January 13, says that drug regulators haven’t done enough to force disclosure of financial conflicts among the researchers who conduct clinical trials of medications and medical devices.

 

Quid-pro-Quo

Financial connections between companies that make drugs and devices, and the doctors and other researchers who test them on humans, may compromise the safety of patients in studies and the integrity of the results.

According to the report, lawmakers led by Senator Charles Grassley [Republican from Iowa] have raised concern that conflicts of interest among doctors and manufacturers may influence prescribing decisions.

Assessment

Furthermore, the report said the “FDA should ensure that sponsors submit complete financial information for all clinical investigators.”  Is this a new or novel idea?

Conclusion

And so, your thoughts and comments on this Medical Executive-Post are appreciated. Is this entire “pay-2-play” or “quid-pro-quo” idea another dark-alley of drug research and development; or not?

Speaker: If you need a moderator or speaker for an upcoming event, Dr. David E. Marcinko; MBA – Publisher-in-Chief of the Executive-Post – is available for seminar or speaking engagements. Contact: MarcinkoAdvisors@msn.com  or Bio: www.stpub.com/pubs/authors/MARCINKO.htm

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FDA Liability Immunity Ruling

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The US Supreme Court Rules

[By Staff Reporters]

Did you know that the US Supreme Court just ruled that makers of medical devices – like implantable defibrillators or breast implants – are immune from liability for personal injuries as long as the Food and Drug Administration [FDA] approved the device before it was marketed and it meets the agency’s specifications? 

Background

In 2004, the administration reversed longstanding federal policy and began arguing that “premarket approval” of a new medical device by the FDA overrides most claims for damages under state law, but because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards, according to the New York Times 

The Ruling

The decision does not foreclose lawsuits claiming that a device was made improperly, in violation of Food and Drug Administration [FDA] specifications, while cases may also be brought under state laws that mirror federal rules, as opposed to supplementing them. 

Devices subject to the premarket approval process, and thus affected by the court’s opinion, tend to be more technologically advanced and expensive, while examples of devices that have been the subjects of recent lawsuits include an implantable defibrillator, a heart pump, a spinal cord stimulator, a drug-coated stent, an artificial heart valve, and prosthetic hips and knees. 

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matrix pills

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Assessment

The Bush administration plans to continue its push for pre-emption from personal injury suits in another FDA case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits.

And so, is this ruling a boon for trial lawyers or patients; both or neither?

Conclusion

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