Ban on Referenced Based Drug Pricing

Posted on January 30, 2009 by Dr. David Edward Marcinko MBA MEd CMP™

A Medicare and CMS Three-Sixty

[By Staff Reporters]

According to Jane Zhang and Vanessa Fuhrmans of the Wall Street Journal, on January 10, 2009, the last days of the Bush administration saw a proposed ban that allows private insurers to charge Medicare beneficiaries stiff penalties if they choose brand-name drugs instead of cheaper generic drugs.

Referenced Based Pricing

Under reference-based drug pricing, the penalty for insisting on a brand-name drug often amounts to the price difference between the drug and the generic version, plus a copayment. In some cases, that leaves patients paying the full price of the brand-name drug. In contrast, buyers of brand-name drugs when there is no generic equivalent are charged just a copayment. Nearly 10% of drug plans used the pricing technique to steer beneficiaries to lower-cost generics www.HealthDictionarySeries.com

CMS Announcement

Of course, the announcement from the Centers for Medicare and Medicaid Services came after lawmakers and patient advocates protested that reference-based pricing made it difficult for consumers to calculate drug costs.

CMS Renouncement

But, the agency reversed itself 360 degrees this week, proposing to ban such pricing for the 2010 drug plans. The WSJ reported that complicated formulas made it “very difficult to accurately convey the extent of expected out-of-pocket spending” for prescription drugs. And, “The basis for this decision is our belief that reference-based pricing may be inherently misleading to beneficiaries and inconsistent with our goal of improving transparency.”

The Pfizer-Wyeth Drug Deal

Following the ban, investors appeared skeptical about the just announced Pfizer-Wyeth drug deal. Pfizer will pay $68 billion for Wyeth, which is the biggest in the drug sector since 2000. The merger comes as Pfizer faces the difficult hurdle of dealing with patent expirations for some of its biggest drugs, including its cholesterol-lowering Lipitor, which makes up about 25% of the company’s overall sales.

Assessment

The ban is part of CMS’s criteria for prescription-drug plans that insurers will offer for 2010. The criteria won’t be final until March, leaving a narrow window for the Obama administration to change them.

Conclusion

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Filed under: "Doctors Only", Drugs and Pharma, Ethics, Managed Care, Research & Development | Tagged: CMS, medicare, Medicare D, referenced based drug pricing | 7 Comments »

Disclosures Lacking in Drug Studies

Posted on January 16, 2009 by Dr. David Edward Marcinko MBA MEd CMP™

New – Dark Alley – Report on Drug Studies

Staff Reporters

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?

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Health Spending Growth Falls

Posted on January 12, 2009 by Dr. David Edward Marcinko MBA MEd CMP™

Flood of Generic Drugs Cited as Causative

[By Staff Reporters]

It is no surprise that payments for everything from doctor visits and hospital construction, to home-health care increased 6.1 % to $2.24 trillion, this decade. But, overall healthcare spending in the US grew the least since 1998, driven by the biggest drop in retail drug purchases in several decades. Think $4 Rxs, and free drugs from Giant Food stores.

Health Affairs Report

According to government reporting in the journal Health Affairs [HA], cheaper copies of heart and blood-pressure drugs such as Merck & Co.’s Zocor, Pfizer Inc.’s Norvasc and Bristol-Myers Squibb Co.’s Pravachol became available in 2006 and 2007.

Assessment

Generic drugs accounted for 67 percent of retail prescription sales in 2007, up from 63 percent the preceding year. As the number of top-selling brands facing generic competition tails off, drug spending may rebound according to Washington health-policy analyst, Paul B. Ginsburg.

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Conclusion

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Filed under: Drugs and Pharma, Health Economics | 1 Comment »

Free Prescription Antibiotics

Posted on January 3, 2009 by Dr. David Edward Marcinko MBA MEd CMP™

Offerings from Giant Food Stores

By Dr. David Edward Marcinko; MBA, CMP™

[Publisher-in-Chief]

Recently, upon return to my home town of Baltimore, Maryland, I observed anecdotally that Giant Food stores was planning to give free generic antibiotics to customers with a prescription for the next three months.

My suspicions were confirmed by the Washington Post, on December 30, 2008, when it reported that the program, which lasts through March 21st 2009, covers several popular antibiotics such as amoxicillin, penicillin and ciprofloxacin. This is the first time that Giant has offered free prescription drugs and it did not estimate the cost or potential popularity of the program.

Assessment

As a kid, I worked as a retail grocery inventory specialist [RGIS]. It was then I learned of the minute profit margins in the business. And so, is the retail grocery competition heating up – and – is this what retail experts called an “aggressive move” in the supermarkets’ heated battle for shoppers? You decide.

Conclusion

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Filed under: Drugs and Pharma, Health Economics, Managed Care | Tagged: free antibiotics, Giant Foods | 6 Comments »

Emory University’s Black-Eye

Posted on January 2, 2009 by Dr. David Edward Marcinko MBA MEd CMP™

Nemeroff Resigns Psychiatry Chairmanship

By Staff Reporters

Senator Charles Grassley’s (R-Iowa) investigation into conflicts of interest among doctors has led Charles Nemeroff to step down from his chairmanship of Emory University’s psychiatry department. Nemeroff, a late career MD-PhD and prominent researcher in clinical depression, has been hit by a steady stream of criticism since Grassley alleged he failed to disclose hundreds of thousands in payments from GlaxoSmithKline.

Unreported Income Galore

According to the Wall Street Journal, December 23, 2008 Emory’s investigation turned up more than $800,000 in income from Glaxo that Nemeroff didn’t report to the university, for more than 250 speaking engagements over six years.

As a mea culpa, Emory won’t ask for research grants or other contracts involving Nemeroff for two years – a voluntary ban that would apply to National Institutes of Health [NIH] funding.

Assessment

Is this a black-eye for Emory University, or just a slight hematoma? Are other “shoes to drop?”

Conclusion

Your thoughts and comments on this Medical Executive-Post are appreciated.

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Filed under: Drugs and Pharma, Ethics, Information Technology | Tagged: Nemeroff | 5 Comments »

Complimentary Literature

Posted on January 1, 2009 by Dr. David Edward Marcinko MBA MEd CMP™

Related Industry Affiliates

Staff Reporters

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D2C Drug Advertising Criticized

Posted on December 21, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

FDA Updates Some Standards

Staff Reporters

According to the Wall Street Journal, December 11, 2008, prescription drug makers updated their voluntary standards for direct-to-consumer advertising to make the ads more informative. But, the measures stop short of changes sought by government and industry critics.

The FDA and “Actors”

The companies said they will halt advertising that includes promoting prescription drugs for non Food and Drug Administration [FDA] approved uses; or using actors as physicians. The guidelines say celebrity endorsers shouldn’t say they use a drug – unless they actually use it.

PRMA Industry Trade Group

The Pharmaceutical Research and Manufacturers of America [PRMA], the industry trade group that issued the standards, reported their aim was to address the concerns of doctors, and Congress while continuing to keep patients informed about valuable treatments. Critics said the changes didn’t go as far as advocated by a panel on drug safety from the Institute of Medicine [IOM], including making company’s wait two years before advertising a prescription drug directly to consumers so that effects can be better understood. Critics also said that television ads should include the phone number at the FDA for patients to call to report side-effects.

Assessment

Under the voluntary standards, only print-ads would include the phone number.

Conclusion

And so, your thoughts and comments on this Medical Executive-Post are appreciated. Are these restrictions enough; or too much?

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Filed under: Drugs and Pharma, Quality Initiatives, Risk Management, Surveys and Voting | Tagged: D2C drugs | 3 Comments »

PPO Pharmacy Benefits Survey

Posted on December 11, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Managerial Results for 2007 – Just Released

[By Staff Writers]

In 2006, the average number of eligible employees in PPOs that used managed care pharmacy programs was 203,768, up 7.2% from 190,097 the previous year.
For the sixth straight year, the share of PPOs that used PBMs for drug utilization review (DUR) services fell, to 62.7% from 66.1% in 2005.
The percentage of reporting PPOs that followed drug formularies increased fractionally in 2006, to 98.6% from 98.3% the year before, the sixth consecutive annual rise.
For the fifth consecutive year, the percentage of reporting PPOs that contracted with mail-service pharmacies grew, to 98.9% in 2006 from 98.3% in 2005.
Between 2005 and 2006, the overall share of PPO prescriptions filled with brand name drugs fell modestly, to 53.8% from 55.4% the previous year.
The average number of contracts between PPOs and hospitals jumped 18.9% in 2006, to 145 from 122 the year before.
The percentage of PPOs using a pharmacy benefit manager (PBM) was 99.2% in 2006, up slightly from 98.6% the year before, and the highest such share since this Digest began tracking this measure.
In 2006, PPOs contracted with an average of 38.9 ancillary providers per 1,000 eligible employees, up 28.4% from 30.3 the previous year, and the highest such number since 2002 (41.4).
At PPOs with at least 1 million eligible employees, the average number of hospital contracts per plan climbed a notable 14.2%, to 1,804 from 1,579 in 2005.

*Acknowledgements

The editors acknowledge Verispan LLC, Yardley, Pa., as the research and reporting source for this data, reprinted with permission and based on information gathered by mail and telephone surveys gathered and effective as of December 31, 2008, unless otherwise noted. It was commissioned, sponsored and underwritten in an arm’s length fashion by the Managed Care Digest Series of sanofi-aventis, Bridgewater, NJ, and developed and produced by Forte Information Resources, LLC, Denver, Colorado.

Conclusion

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Filed under: Drugs and Pharma, Surveys and Voting | Tagged: pharmacy benefits | 6 Comments »

Introducing MyMedLab

Posted on December 9, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Direct to Consumer [D2C] Laboratory Services

Staff Reporters

MyMedLab began as a regional lab provider in Missouri in 1993. The company was created to allow patient-consumers to make informed care choices. In 2004, the company aimed to partner with industry leading providers and the power of the Internet to take the company and its electronic interface national.

Health Information Innovation

According to their website www.MyMedLab.com, this new business model created an innovative approach that dramatically lowered costs and gave patient-consumers direct access to the same health information once only available to doctors. Leveraging more than 20 years of laboratory experience, MyMedLab was able to create one of the first “direct to consumer” [D2C] laboratory services in the country.

Mission

From inception, the mission of MyMedLab was to provide consumer-patients with an affordable and convenient way to privately learn about their health. When combined with an annual exam, their screenings create a foundation for health care of the future, one focused on prevention and early detection.

Smart Patient-Consumers

Smart patient-consumers receive this information privately, outside their permanent medical records, and then share results when it enhances their care. Knowing what is important and what questions to ask maximizes the time and money spent with personal physicians. The MyMedLab process combines transparent pricing with the services of a board certified physician in every state. This unique combination eliminates the cost and inconvenience of a doctor’s visit just to order routine testing. It provides essential physician oversight throughout the entire process while still guaranteeing complete privacy.

Purchased Testing

Testing can be purchased 24 hours a day. Tests are listed both individually and in groups called Wellness Profiles based on age, sex and family history. For patient-consumers with testing ordered by their doctor, MyMedLab provides an easy way to purchase the same testing at a cost 50%-80% less than in their doctor’s office or local hospital lab.

Electronic Medical Records

MyMedLab customers purchase testing online, or by phone, and then visit one of nearly 2,000 local Patient Service Centers (PSC) in their neighborhood. Once samples are drawn, results are securely uploaded to their private personal health record (PHR) within 24-48 Hours. A notification email is sent when results have been released and are ready for review. Patients then simply log into their PHR account at MyMedLab to view their results. Each result includes a brief explanation and a direct link to the National Library of Medicine [NLM] for more detailed result information.

Assessment

Everything done at MyMedLab is designed to put the patient-consumer back in control. Since “knowledge is power in health care”, their vision of the future is to continually introduce new technology and services, to enhance the consumer-patient experience, and to transform the way we all learn about our health.

Conclusion

As always, your thoughts and comments on this Medical Executive-Post are appreciated. Does this D2C laboratory model empower or denigrate the physician-doctor relationship in the era of Health 2.0?

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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Filed under: Drugs and Pharma, Health Economics, Information Technology, Research & Development | Tagged: blood tests, laboratory services, medical labs | 1 Comment »

Extortion Argument for HIT De-Identification

Posted on November 24, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

A Really Scary Tale

By D. Kellus Pruitt; DDS

Upon arriving at the office early one morning recently, Dr. Smith logged on to the Internet to check her email. Among the usual pieces of junk email, one from Nigeria caught her eye. She recognized the name of one of her patients, written in bold letters. She thought, “That’s odd.” Smith opened the email to read more.

The Threat

“I am revealing the name of your patient, who lives on Oak Street, as proof that your computer has been hacked. I have social security numbers, birthdates, insurance information … You name it, and I’ve got it. It will go on the market in 24 hours if you do not do exactly what I say …” (This is the start of price negotiations – for the first time).

The Decision

What will Dr. Smith do? At the very best, she can hope that it’s a bluff. Nevertheless she must contact not only the FBI, but every one of her patients who are at risk of identity theft. That alone will bankrupt her practice because a large portion of her patients will never return. They will look for dentists with paper records. The very worse thing she could do is pay the ransom. In the end, how much did the bad guy risk to destroy a wonderful career, even if it was a bluff, or a devastatingly mean trick? You can relax now; this story is fiction. Here is the non-fiction.

NEWS FLASH!

“Script said the new letters were received by Express Script clients in recent days and is similar to the letter it first received. That letter included personal information on 75 people covered by Express Scripts, including birth dates, social security numbers and prescription information. The sender demanded money from the company, under the threat of exposing records of millions of patients.” – BusinessWeek [11.11.08]

More: http://www.businessweek.com/ap/financialnews/D94CVLJO0.htm

Lose the Threat

Dentists must lose this danger or lose their computers. Let’s temporarily put aside our dreams about how wonderful technology might become and open our minds to ways to go around insurmountable obstacles instead of pretending everything is wonderful in stakeholder land. For once, let’s seriously look into de-identifying our patients’ electronic dental records already. Forget about HIPAA and inspections. Forget about AHIC Successor Inc. Forget about CCHIT, CMS and even the HHS. Forget about Newt Gingrich and the past, present and future Presidents of the American Dental Association who prefer to be irrelevant than to discuss anything bad about electronic dental records. And especially forget, with prejudice, executives of dental insurance companies who demand interoperability on their NPI-driven terms. Let’s sidestep the biggest mistake in healthcare history. It does not have to be ours.

More Info: Dictionary of Health Information Technology and Security

www.HealthDictionarySeries.com

Not a Fete’ Accompli

Some leaders who have poor understanding of the modern marketplace would lead ADA members to believe that there is nothing that can be done to stop eHRs in the United States of America, no matter how expensive, dangerous and lousy stakeholder interests make them. Why; “cause I said so?”

Example:

Let me give you an example: “If we don’t participate, then who knows what will happen regarding the dental part of the eHR? eHR is on the way.” – Dr. John S. Findley, President of the ADA in “President-Elect’s Interview: Part 2,” ADA News Online (ADA members only).

More: http://adabei.com/members/resources/pubs/adanews/081006_findley.asp

If we don’t participate, Dr. Findley, dentistry will proceed with safe paper records like it has for a century or so. I have clearly shown that far worse things could happen. Shouldn’t we “first do no-harm” to our dental patients? What happened to the ethics of the American Dental Association?

Stakeholder Optimism

Even though optimistic stakeholders, hobbyists and hangers-on disagree with me, electronic dental records are not inevitable. At least they are not inevitable in the next decade or so. They can easily become so lousy and so mistrusted by doctors and patients alike that they will set back miracles from Open Source Evidence-Based Dentistry forever. They are almost there already because of ambitious stakeholders, hobbyists and slow-moving hangers-on; like Dr. John S. Findley.

Assessment

Remember, decades ago the US was supposed to be on the metric system. Sometimes inevitability takes so long that you might as well just forget about it. And, the metric system even makes sense.

Conclusion

Unlike medical records which must remain secure even if de-identified, nobody, I repeat, nobody cares about breached dental histories. Physicians may have no choice. Dentists do! As always, your thoughts and comments on this Executive-Post are appreciated.

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Filed under: Drugs and Pharma, Health Law & Policy, Information Technology, Professional Liability | Tagged: AHIC, CCHIT, Express Scripts, HHS, HIT, NPI | 2 Comments »

Health IT, the Markets and the New Administration

Posted on November 10, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Digital Technology and Future Federal Health Policy

Staff Reporters

According to the Dow Jones Newswires, at 12:17 PM ET on 11/05/2008, companies providing digital technology to manage patient records and prescribe drugs are likely to benefit from the administration of Barack Obama.

Health IT Beneficiaries

Why? President-elect Obaba wants to spend $50 billion to computerize the US medical infrastructure and several companies could benefit.

For example, Irvine, Calif.-based Quality Systems Inc. (QSII), Watertown, Mass.-based Athena Health Inc. (ATHN) and Chicago-based Allscripts-Misys Healthcare Solutions Inc. (MDRX) are among the companies that could benefit, directly or indirectly, from government money as a result of an as-yet vaguely defined high-tech health-care proposal.

Other IT Companies

Many more companies, including Allscripts’ hardware partner, Round Rock, Texas-based Dell Inc. (DELL), could even see revenue rise if investment takes off; according to the Charles Schwab Company.

Assessment

And – as reported – according to John Sheils – senior VP of the Lewin consulting group in Virginia – “This is going to be a boon because there will be demand for these systems, then demand for maintenance and improvements, plus the software that people would need,”

Conclusion

Your thoughts and comments on this Executive-Post are appreciated. What say our financial advisors and investment consultants?

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Filed under: Drugs and Pharma, Information Technology, Investing | Tagged: Allscripts, Athena Health | 1 Comment »

New Federal eRx Incentives

Posted on November 7, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Program to Begin on January 1, 2009

By Staff Reporters

According to the Kaiser Daily Health Policy Report, of November 2, the Centers for Medicare and Medicaid Services [CMS] confirmed details of an electronic prescribing incentive program for physicians. Scheduled to begin on Jan. 1, 2009, it would increase Medicare payments for doctors who use the health information technology.

New Program

And, under the new program, according to the Kaiser Daily Health Policy Report, physicians who use e-prescribing technology to deliver medication prescriptions to pharmacies will be eligible for a two percent increase in their Medicare payments. Physicians who participate in the agency’s Physician Quality Reporting Initiative [PQRI] would also qualify for a two percent payment increase in addition to the scheduled 1.1 percent payment increase for all physicians in 2009.

Assessment

Physicians who participate in both the e-prescribing and PQRI initiatives would receive a 5.1 percent bonus in Medicare payments next year.

Conclusion

Your thoughts and comments on this Medical Executive-Post are appreciated.

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Filed under: Drugs and Pharma, Information Technology, Practice Management | Tagged: eRx | 11 Comments »

About Clinician 1.com

Posted on November 6, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Physician Assistants Establish Online Presence

Staff Reporters

As face-time with doctors is increasingly limited, the role of physician and nurse practitioners has become integral in the healthcare system. However, it hasn’t exactly become easier for PAs and NPs to obtain information about drugs and treatments. That’s about to change according to George Koroneous, the Online Content and News Editor for Pharmaceutical Executive.com on October 8, 2008.

Just Launched

Launched last week, www.Clinician1.com is a Facebook-style social networking site targeted to the 200,000 physician and nurse practitioners that prescribe drugs in all 50 states. It features personal information pages, medical education, and areas to facilitate two-way conversations between like-minded clinicians.

Website Proposition

According to its’ website, Clinician 1 was created by leading Nurse Practitioners [NPs] and Physician Assistants [Pas]. Clinician 1 is the first Internet community where NPs and PAs across all specialties can connect, consult and converse.

Assessment

More info: http://pharmexec.findpharma.com/pharmexec/Marketing/Physician-Assistants-Establish-Online-Presence/ArticleStandard/Article/detail/556966?contextCategoryId=39717

Conclusion

Your comments on this new professional network are appreciated.

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Filed under: Career Development, Drugs and Pharma, Practice Management | Tagged: NPs, PAs | Leave a comment »

Singing the Wiki Pharma-Blues

Posted on November 4, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Allegations of e-Chicanery at Abbott Laboratories

Staff Reporters

According to Walter Armstrong, of Pharmaceutical Executive on October 1, 2008, Abbott Laboratories recently edited its Wikipedia entry in an attempt to bolster its e-image.

Seeking Image Redeux

A fellow named Jeffrey Light, the young founder and head of tiny DC-based nonprofit Patients not Patents hit the wires recently, charged that Abbott Laboratories edited its entry in Wikipedia, the online everybody-can-play encyclopedia, trying to make itself look better.

Track-Backs

Using a brand-new online tool called the Wiki Scanner, which allows anyone to track-back the source of any change entered into any of Wikipedia’s 2 million articles, Light discovered that at 4:38 P.M. on July 2, 2007, several edits to the article on Abbott were made from a computer at Abbott’s Chicago office.

Assessment

We surmise the aging folks at Abbott are unfamiliar with the blogging concept of track-backs and pings; etc.

http://pharmexec.findpharma.com/pharmexec/Back+Page/The-Wiki-Incident/ArticleStandard/Article/detail/463111?contextCategoryId=39722

Conclusion

As creators of the modified wiki enabled printed dictionary series: www.HealthDictionarySeries.com, we are saddened by these developments; if true. And so, your thoughts and comments are appreciated.

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Filed under: Drugs and Pharma, Information Technology | Tagged: Abbott Laboratories, blogs, wiki | Leave a comment »

The Pfizer Website

Posted on September 28, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

A Medication Safety Initiative

Staff Writers

Pfizer, Inc will be launching a website, now under beta construction, on medication safety to help consumers weigh drug risks and benefits. This is considered, by some, an unusual move in an industry often criticized as using marketing practices that oversell drug benefits and downplay risks.

Patient Advocacy

According to the Associated Press on September 16, Pfizer plans to promote the site by working with medical and patient advocacy groups, as well as with online advertising on websites targeting medical professionals and patients.

Assessment

The detailed future site will include sections written for patients and for health professionals, with plain-English explanations, engaging graphics and clips of video hosts discussing important points. It will also have a prominent link to information about how to report a drug side effect to Medwatch, the Food and Drug Administration [FDA] reporting program.

Conclusion

Your thoughts and comments are appreciated. Is it about time to launch this patient safety initiative; or far too late?

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Filed under: Drugs and Pharma, Quality Initiatives | Tagged: FDA, Pfizer | 1 Comment »

Eli 2 Disclose

Posted on September 27, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Financial Transparency to Increase

[By Staff Reporters]

In a pharmaceutical industry first, Eli Lilly and Co. said it will begin disclosing how much money it paid to individual doctors for advice, speeches and other services.

The drug company’s move comes as members of Congress push a disclosure bill in an effort to prevent such payments from improperly influencing medical decisions.

Conclusion

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Filed under: Breaking News, Drugs and Pharma | Tagged: Eli Lily | 2 Comments »

Medicare Benefits Report

Posted on September 11, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

2007 Payment Services Review

Staff Reporters

In 2007, benefit payments for the four parts of Medicare totaled $426 billion and allocated as follows:

Part A: Hospital Insurance = 41% (includes home health which is partially funded under Part B)

Hospital Inpatient = 30%
Skilled Nursing Facilities = 5%
Home Health = 4%
Hospice = 2%

Part B: Supplemental Medicare Insurance = 28%

Physicians and other suppliers = 20%
Hospital Outpatient = 4%
Other Part B benefits = 4%

Part C: Medicare Advantage (private health plans) = 18%

Part D: Prescription Drug Benefit = 12%

Payments to Drug Plans = 7%
Low-Income Subsidy Payments = 4%
Payments to Union/Employer-Sponsored Plans = 1%

Note: Does not include administrative expenses such as spending for implementation of the Medicare drug benefit and the Medicare Advantage program. Total is net of $8.1 billion in recoveries for 2007.

Data Source: Congressional Budget Office, Medicare Baseline, March 2008.

Publication: Medicare Spending and Financing Fact Sheet; September 2008. The Kaiser Family Foundation.

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Launching iGuard.org

Posted on September 7, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Institute for Safe Medication Practices

Staff Reporters

A new patient-oriented Web site is scheduled for release this fall to reduce mix-ups over drug names.

The ISMP

The Web site is a partnership of the nonprofit Institute for Safe Medication Practices, and online health service www.iGuard.org, which will send users email alerts about drug-name confusion.

Dug Mix-Ups Not Rare

According to an Associated Press report on September 2^nd, nearly 1,500 commonly used drugs have names so similar to at least one other medication that they’ve already caused mix-ups.

Patient Harm

And, according to a major study by the U.S. Pharmacopeia, at least 1.5 million Americans are estimated to be harmed each year from a variety of medication errors, and name mix-ups are blamed for a quarter of them.

The Food and Drug Administration [FDA] – which currently rejects more than a third of proposed names for new drugs because they’re too similar to old ones – is preparing a pilot program that would shift more responsibility to manufacturers to guard against name confusion.

The Site

According to the website, iGuard.org is a healthcare service initiative that helps monitor the safety of medications (including prescription drugs, over-the-counter drugs, nutritional supplements and herbal extracts).

iGuard.org reportedly will help patients stay safer by:

Checking the safety of medications, and screening for drug-drug and drug-disease interactions.
Alerting members and doctors (optional) as important safety information arises for medications.
Provide accessible medication summaries for healthcare teams.
Help patients learn and share treatment satisfaction and side effect information within its social community.

Assessment

The goal of the site is to spell-out how to better test for potential mix-ups before companies seek approval to sell their products.

Conclusion

Your thoughts and comments are appreciated.

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Filed under: Drugs and Pharma, Information Technology, Professional Liability, Quality Initiatives, Research & Development, Risk Management, Uncategorized | Leave a comment »

Report on Hospital Risks

Posted on September 6, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

An IOM Review for Us All

[By Staff Reporters]

Hospitals manufacture miracles by the millions. But, they can also be hazardous to your health.

IOM Report

According to the Institute of Medicine [IOM], a non-profit organization chartered by the US National Academy of Sciences, at least 1.5 million Americans fall prey to hospital error every year.

And, these mistakes aren’t exactly minor either; as between 40,000 and 100,000 people die every year because of shoddy handiwork, including surgical mishaps and drug mix-ups.

Drug Problems

One big problem is that hospital patients may get the wrong drug one time out of five times [20%], according to a study by Auburn University. The death toll from these mistakes is at least as bad as that from car accidents or breast cancer, and may be as bad as that from strokes.

Infections

Another 100,000 people die because of infections from hospital-bred [nosocomial] bacteria that are resistant to one or more of the antibiotics doctors use to kill them off, according to the Center for Disease Control [CDC]. Some of those might be prevented by more hand washing or other precautions.

Assessment

Of course, medical provides, health economists, advisors, administrators and Executive-Post subscribers are familiar with these mistakes; but the public may not be – until now!

And so, this is your chance to learn what the public is reading about this vital issue from Forbes.

Link: http://health.msn.com/health-topics/articlepage.aspx?cp-documentid=100214300&gt1=31036#

You may be surprised, and dismayed!

***

Channel Surfing the ME-P

Conclusion

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* 8

Filed under: Drugs and Pharma, Professional Liability, Quality Initiatives, Risk Management | Tagged: IOM | 2 Comments »

The Healthcare Whistleblowers

Posted on September 5, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

A New DOJ Report

[By Staff Reporters]

According to the Deportment of Justice [DOJ], $9.3 billion was recovered from health care providers accused of defrauding the states and federal government the past decade.

The Study

The department ramped up efforts in the 1990s to combat healthcare fraud by using private citizens with insider knowledge of wrongdoing. They now initiate more than 90 percent of the department’s lawsuits focusing on fraud in health care, and receive between15 percent and 25 percent of the amounts recovered.

The Results

According to an Associated Press report on September 2, of the $9.3 billion recovered between 1996 and 2005, whistle blowers got more than $1 billion. And, while the number of claims dropped in recent years, recovery amounts have soared – jumping from about $10 million a case in 2002 to $50 million by 2005.

Assessment

The reason for this up-tick was the late addition of pharmaceutical manufacturers to the list of defendants.

Conclusion

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Filed under: Drugs and Pharma, Health Economics, Health Law & Policy, Healthcare Finance, Practice Management | Tagged: health fraud, whistleblowers | 54 Comments »

23 and Me

Posted on August 29, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Personal DNA Analysis and Reporting

[By Staff Reporters]

Ever wondered why you were left-handed and your sibling or parent wasn’t?

A not-so-new new company, 23andMe, provides an analysis of DNA, where you can learn more about yourself, your immediate family and even your ancestry.

Target Markets

Those who would be especially interested in this personal genome service include:

Methodology

Customers [sic patients] submit a small saliva sample that is processed using a proprietary custom DNA chip. The resulting data is then presented on a secure website using interactive tools that offer information about ancestry, inherited traits and disease risk.

Board of Directors

This is no lightweight company. It technology founders include:

Linda Avey
Anne Wojcicki
Esther Dyson

While its’ medical advisors are:

Uta Francke; MD [Professor of Genetics and Pediatrics, Stanford University].
Itsik Pe’er; PhD [Assistant Professor of Computer Science, Columbia University].
Peter A. Underhill; PhD [Senior Research Scientist, Stanford University].

Assessment

You can also better understand your genetic tendencies for things like obesity or health issues.

There is even an interactive blog: http://spittoon.23andme.com

Users can find other members with similar genetic makeup and start discussions. And, it is $999 to order a kit for the DNA test.

Conclusion

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Filed under: Drugs and Pharma, Information Technology, Media Mentions and PR, Research & Development | Tagged: DNA, genome | 12 Comments »

New Academic Drug-Detailing Model

Posted on August 13, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

“Impartial Experts” May Launch Soon

Staff Reporters

According to the Wall Street Journal, July 31 2008, the federal government could start paying impartial experts to visit doctors to talk about the safety, effectiveness and cost of prescription drugs and other treatments.

Enter the New “Detailers”

These “academic detailers” would give presentations along the lines of those given by Big-Pharma drug representatives, while the federally funded presentations would provide a counterweight to the industry messages on specific drugs.

And, according to a confidential source, one can only wonder if these folks will be selected on the basis of, er, their “physical attributes” like those detailers “back-in-the-day”, among other professional considerations?

Assessment

Seriously, Senator Herb Kohl, a Wisconsin Democrat, held a hearing on the issue earlier this year and is one of the sponsors of a bill that authorizes the government to contract with nonprofit groups such as medical societies, schools of medicine and pharmacy, to create the educational materials.

It also directs officials to contract with 10 entities – drawn from academic institutions, state or local governments and non-profit groups – to train and deploy health care professionals to educate physicians and other drug prescribers.

Conclusion

Your thoughts and comments are appreciated; is this proposition a real value-added service, or yet another governmental boondoggle?

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Filed under: Drugs and Pharma, Practice Management | Tagged: drug detailing | 1 Comment »

Internet Drug Rx Abuse

Posted on July 30, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

NCASA Study

Staff Reporters

A large majority of 365 Internet sites that advertise or sell controlled medications by mail are offering to supply the drugs without a proper prescription, while the online trade is stoking the rising abuse of addictive and dangerous prescription drugs, according to a National Center on Addiction and Substance Abuse [NCASA] at Columbia University.

The Study

Federal and state efforts to crack down on Internet sales appear to have reduced the number of sites offering such drugs, from 581 last year, according to a New York Times report on July 9, 2008. Drugs offered online include generic versions of opiates like OxyContin, methadone and Vicodin, which are legitimately prescribed as painkillers; benzodiazepines like Xanax and Valium, which are prescribed for anxiety; and stimulants like Ritalin.

DEA Assessment

The Drug Enforcement Administration [DEA] found that 85 percent of all Internet prescription sales involved controlled drugs, compared with just 11 percent of those filled through regular pharmacies, suggesting that online sales often are destined for misuse.

Conclusion

Do you think the current eRx initiatives will drive or reduce this phenomenon; please opine and comment?

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Filed under: Breaking News, Drugs and Pharma, Health Law & Policy, Information Technology, Surveys and Voting | Tagged: internet, Rx | 3 Comments »

Prescription Quantity Survey

Posted on July 27, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

The IMS Health Data Study

Staff Reporters

Did you know that the number of prescriptions dispensed by pharmacies in the U.S. is growing at its worst rate in at least a decade, as consumers are squeezed by both a troubled economy and the growing burden of out-of-pocket health-care costs?

The IMS Report

Data from market researcher IMS Health and Wall Street analysts indicate that the rate of prescription growth has fallen steadily since early last year, with preliminary data suggesting the number of prescriptions actually fell in the second quarter, according to the Wall Street Journal on July 16, 2008.

Big Pharma Brands Collapse

The hit is coming at the expense of some of the industry’s biggest brands. For example, in May 2008, branded medicines accounted for 30.6 percent of treatments dispensed, down from 45.9 percent in 2003, the WSJ noted.

Assessment

Pills for such chronic conditions like cardiovascular disease are also vulnerable, since patients tend to think they can do without treatments for so-called silent diseases more easily than for conditions such as cancer, or HIV.

Conclusion

Your thoughts are appreciated. Have you seen this happening in your practice, clinic or hospital setting? Please comment and opine.

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Filed under: Drugs and Pharma, Quality Initiatives, Surveys and Voting | Tagged: big-pharma, IMS Report, prescriptions | Leave a comment »

Top Ten Brand-Name Elder Drugs

Posted on April 13, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Top 10 Brand-Name Drugs Ranked by Prescriptions Filled in PACE*

Rank	Drug Name	Type of Drug	Median Negotiated Monthly Price
1	Lipitor	Cholesterol	$79.12
2	Plavix	Cardiovascular	$125.91
3	Protonix	PPI	$117.67
4	Nexium	PPI	$145.09
5	Fosamax	Osteoporosis	$79.15
6	Diovan	Cardiovascular	$57.54
7	Aricept	Dementia	$158.49
8	Zetia	Cholesterol	$87.06
9	Actonel	Osteoporosis	$83.60
10	Prevacid	PPI	$146.41

*PACE = Pennsylvania’s Pharmaceutical Assistance Contract for the Elderly (PACE) program

Data Source: PACE utilization data and Hargrave et al. analysis of data on pricing from the CMS Medicare Prescription Drug Plan Finder on Medicare.gov, for the Kaiser Family Foundation.

Publication: Medicare Part D 2008 Data Spotlight: Ten Most Common Brand-Name Drugs, Kaiser Family Foundation, April 2008. http://www.kff.org/medicare/7749.cfm

Assessment

The above is self-explanatory.

Conclusion

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Filed under: Drugs and Pharma | 1 Comment »

Big Pharma’s Dilemma

Posted on April 8, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Making it … Without Big Pharma

By Patrick C. Cox; Jr.

[Pharma Section Editor]

How are we going to make it without Big Pharma?

An alarming question but a very real one we nonetheless might have to face over the next few years. Look, we’ve become accustomed to Big Pharma delivering that blockbuster drug just when we need it. With patience and strong research and development, somehow we’ve all felt the drug industry would be there for us in the end. Reality is starting to set in however.

Given today’s business climate and the pressures of recent economic downturns, one must begin to ask:

Can we count on Big Pharma to be there for us at the level we’ve come to expect?

The Need Exists

Healthcare needs and consumer pressures for blockbuster compounds are certainly still there. Who doesn’t feel a sigh of relief when news of FDA approval for a product personally affecting our family or us hits the streets? One would like to think that the drug industry is primed and eager to keep the launch engines of innovation rolling, but that’s easier said than done in today’s business environment. It’s the same economics we all face.

Generic Competition Heats Up

Faced with the need to keep a lid on costs while producing dividends to attract new shareholders, there’s also the growing threat from generics. Sales and marketing expenses continue to skyrocket as companies compete for physician, and HMO, brand loyalty and dwindling patient drug dollars. Pressures are greater than ever.

The Questions:

What’s Big Pharma to do to keep delivering? What adjustments to traditional business models will it have to make? How can the industry keep giving us what we need to improve and prolong our lives while it fights just to survive?

Conclusion

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Filed under: Drugs and Pharma | 4 Comments »

Federal Drug Detailing Program

Posted on March 19, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

New Proposal for “Academic” Detailing

[By Staff Writers]

A bill will soon be introduced in the United States Senate that would offer physicians an alternative source for the latest information about new drugs, instead of relying on pharmaceutical manufacturers and retail drug representatives.

The Proposal

The legislation, sponsored by Senators Herb Kohl (D-Wisconsin) and Dick Durbin (D-Ill.) would create a federal “academic” detailing program to produce independent educational materials for physicians and medical professionals on the safety and comparative effectiveness of prescription drugs.

This would include generic and over-the-counter products, based on research at pharmacy and medical schools, according to Modern Physician.

Assessment

Now, some academic detailing services have already been implemented at the state level and by integrated health systems such as Kaiser Permanente, while preliminary results suggest that these programs have effectively changed prescribing behavior while reducing health care costs.

Conclusion

And so, what are your thoughts on the matter; please comment and opine?

***

Filed under: Drugs and Pharma | Tagged: Big Pharma and Drugs | 2 Comments »

Controlled Substance Risks in Medical Practice

Posted on March 10, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Understanding DEA Perils

[By Dr. Charles F. Fenton III; Esq]

The Drug Enforcement Agency (DEA) controls the issuance of DEA numbers that permit the physician to prescribe controlled substances to their patients.

The use of controlled substances is important to almost all medical specialties.

Family practitioners use codeine to treat coughs and surgeons use narcotics to manage pain. The spectrum-of-use is wide.

The Dilemma

Unfortunately, there will always be a rogue physician willing to sell narcotic prescriptions. These physicians cause the DEA to cast a jaundiced eye towards all physicians.

However, the dilemma may be that there are simply too many stories of physicians who “over-use” controlled substances in a practice designed to ease the suffering of their patients; or not?

And, how do we differentiate among them all?

Assessment

The physician never knows when a patient coming into the office complaining of pain and asking for pain medication – whether that patient is truly in pain or not – is an undercover agent for the DEA.

Has it come to prescriber beware?

Conclusion

This peril and paranoia (combined with the risk of a malpractice claim of “hooking” the patient) causes some physicians to actually under prescribe pain medication. So, your thoughts on this ME-P are appreciated.

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FDA Liability Immunity Ruling

Posted on February 23, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

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.

***

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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Filed under: Drugs and Pharma | Tagged: Drugs, FDA, Health Law & Policy | 2 Comments »

The Jarvik Affair

Posted on February 14, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

“What’s up with That?”

By Patrick C. Cox, Jr

How many times have you viewed the Lipitor® “educational” commercial featuring Dr. Robert Jarvik?

If you are like me, probably often since Pfizer appears set on getting their money’s worth from the production. The spot pops up everywhere it seems. Pretty impressive with the rowing, the lake, and natural beauty along with a heartfelt pitch from Jarvik on what a difference Lipitor® has made in his life.

He shares his thoughts that Lipitor® is one of the most researched drugs and he’s glad that he takes it as a doctor, and a dad.

Well, the commercial may have run one time too many. Questions have been raised by consumers and now congressional figures as to Jarvik’s credibility and his Lipitor® endorsement.

For example, he never pursued a medical internship, is not licensed to practice and can’t legally prescribe.

Of course, Jarvik has been recently defending his status as a scientist and his role in simply educating the public in the ad. But, his revelation as a past Lipitor® patient, with implied personal endorsement, could certainly make patients feel they’re missing something if they too aren’t taking the compound.

Assessment

Of course, we all know the real reason behind the ad. Pfizer has invested millions hoping Jarvis’s personal endorsement will get patients saying to themselves, “Hey, Dr. Jarvik prescribes it for his patients and takes it himself, how come I’m not on it?”

The next step they’re hoping for is for them to ask their “prescribing” physician the same thing.

Assessment

Well that’s the problem, isn’t it? Lipitor® is a good drug, but it’s not for everyone. And, only doctors should know what’s best for their own patient’s; right?

So, should drug companies be held accountable for these ads and/or provide more disclosure to the public?

In other word’s, should Pfizer have told us that Jarvik isn’t really a doctor, can’t and isn’t prescribing anything to anyone – and wait a second – did he really even take Lipitor® at all?

Guess only his “prescribing” physician would know, for sure!

Conclusion

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Filed under: Drugs and Pharma | Tagged: Big Pharma and Drugs | 5 Comments »

The 2008 MEDMARX Report

Posted on February 9, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

United States Pharmacopeia [USP]

Staff Reporters

After examining records submitted by 870 hospitals to MEDMARX, a database run by the United States Pharmacopeia (USP), a new report finds that 1.4 percent of mistakes resulted in patient harm, including seven errors that may have caused or contributed to death. The study implicated 1,470 different drugs in errors associated with brand or generic names that looked or sounded similar. The USP compiled an even longer list of 3,170 name-pairs that looked or sounded alike.

Assessment

Medication mix-ups doubled since 2004 driven largely by a troubling proliferation of prescription drugs with confusingly similar names. The 2008 total is nearly double the 1,750 pairs that USP identified in the 2004 study.

Conclusion

And so, how is this possible with bar-coding, RFID tags, eMRs, CPOEs and related modern inventory management technologies?

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Filed under: Drugs and Pharma | Tagged: Big Pharma and Drugs | 1 Comment »

Health Plans Draws Fire for Physician Incentives

Posted on February 1, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Doctors May Profit from Generic Drug Switch

Staff Writers

Several of the nation’s health plans are drawing scrutiny for offering financial incentives to entice doctors to prescribe cheaper generic medicines; according to a recent report from the Wall Street Journal.

This practice includes paying them up to $100 each time they switch a patient from a brand-name drug to a generic equivalent.

As some pharmaceutical patents for a growing number of blockbuster drugs expire, some health insurers are using doctor-bonuses for writing more generic prescriptions.

Proponents argue that the goal of saving patients, employers and insurers money is a noteworthy one. Others argue that it is only justified to reimburse doctors for spending time evaluating patients to determine whether a cheaper generic alternative is better – not for paying them for a wholesale switch.

But aggressive approaches, like cash-rewards for each patient switched from a given list of drugs, are coming under fire for injecting financial incentives into what should be a purely medical decision.

And, some medical societies are concerned that rewards may put doctors in the ethically questionable position of taking payments that patients know nothing about.

Conclusion: And so, what are your thoughts on the matter?

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Filed under: Drugs and Pharma | Tagged: Big Pharma and Drugs | 1 Comment »

Does Merck & Company Give Refunds?

Posted on January 28, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

“I Want My [Prescription-Drug] Money Back!”

[By Patrick C. Cox; Jr.]

Merck & Company may have to as a result of a recently filed lawsuit in the state of Florida.

Coming on the heels of the disappointing Vytorin™ Enhance Trial results, patient Marion J. Greene, 72, is suing to get her money back. She had been taking Vytorin™ at $100 a month instead of generic cholesterol medications at about one third the costs.

Apparently Ms. Greene feels she hasn’t been getting her money’s worth and claims Merck has misled the public. Although some of her costs were reimbursed, she is seeking a refund of what her attorneys are calling “overpayments.”

Class Action Lawsuit Status Sought

The lawsuit has been filed in Jacksonville and attorneys are seeking class-action status charging Merck & Co. with misleading patients about the effectiveness of Vytorin™.

State consumer protection laws, breach of warranty, and unjust enrichment law violations will form the basis of the charges that Merck overstated Vytorin’s effectiveness vs. generics.

Oversight

The lawsuit certainly will raise more public eyebrows and questions about drug company sales and marketing practices.

You can bet too that Congress will be looking into expanding its oversight as the public demands more accountability. With more awareness and scrutiny physicians cannot afford to be caught in the middle by continuing take drug company promotional claims at face value.

As things heat up MD/DO’s can count on being challenged even more to defend their choices of one medication over the other, or they too could be faced with a patient screaming, “I want my money back!”

Assessment

Has a patient ever cried foul like this to you; if so, what have you done?

Conclusion

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Filed under: Drugs and Pharma | Tagged: Big Pharma and Drugs | 3 Comments »

CD-HCPs and Pharmacy Benefits

Posted on January 22, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Safety and Compliance Needed

[By Staff Writers]

A new report suggests that Consumer Directed-Health Care Plans and Pharmacy Benefits Plans [PBPs] must focus on safety and compliance.

The survey, done by the Employee Benefit Research Institute [EBRI], found that nearly 70% of those enrolled in consumer-directed health care plans (CD-HCPs) said that they considered costs when deciding to see a doctor or filling a prescription. This compared with fewer than 40% of those in a more traditional comprehensive health insurance plan.

Assessment

However, the survey also found that CD-HP enrollees were twice as likely to avoid, skip or delay healthcare services. Is anyone surprised; please opine?

Note: CD-HCPs: aka High-Deductible-Health Care Plans [HD-HCPs]

Conclusion

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Dictionary of Health Economics and Finance
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Filed under: Drugs and Pharma | Tagged: High Deductible-HCPs | 5 Comments »

Economics of Statins [Trials]

Posted on January 18, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

The Competition Heats-Up

[By Patrick C. Cox; Jr.]

The chances are pretty good that you are taking a proven compound – called a statin – on a daily basis along with millions of other patients. The drugs are relatively safe, easy to take, widely available, and covered on most healthcare insurance plans … And, they do work.

While not a license to do or eat whatever we want; a smart lifestyle and diet along with a statin will result in reduced cholesterol levels in most patients.

But, there’s lots of pharmaceutical manufacturer competition and the results will be dramatic. Billions of dollars will be spent on statins alone this year. And, the stakes are high.

The Vytorin™ Enhance Trial

With the recently released but disappointing results of the Enhance Trial where Vytorin™ did not reduce arterial plaque, the race is heating up between manufacturers. The contest is for a drug company to be able to lay claim to the statin efficacy “crown” – lower cholesterol and favorable results on arterial plaque.

But of course, you have to prove it first and then have the medical community buy-in.

Saturn Trial Launching Soon [Crestor™ versus Lipitor™]

Within the last few days AstraZeneca has announced plans for launch of the Saturn Trial pitting its A/Z’s Crestor™ 40 mg. – against Pfizer’s Lipitor™ 80mg. The goal is to prove product superiority in the ability to decrease – or regress – atherosclerosis over a two-year period.

Future Trials?

Of course, millions of dollars are on the table in both research costs and potential long-term revenues. And, we’re likely to see similar comparative trials on the horizon as companies struggle to increase their statin market share.

Assessment

And so, are statins worth this kind of attention and associated research dollars? Health economists call this type of ciphering a “cost-volume-profit-analysis [CVPA].”

Or, should big-pharma drug companies be putting their research dollars toward the discovery of more novel compounds?

Conclusion

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Filed under: Drugs and Pharma | Tagged: Big Pharma and Drugs | 2 Comments »

Free Drugs for the Affluent

Posted on January 17, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Pharmaceutical Samples to Wrong Patients [PRMA]

[By Staff Writers]

Most free drug samples that physicians reserve for poor or uninsured patients actually go to wealthier patients who have insurance, reports a new study by the American Journal of Public Health [AJPH].

Patients with the highest incomes were the most likely to get free samples, according to the survey of nearly 33,000 Americans, while only 28 percent of those who got samples were poor, whether insured or not, with incomes less than twice the federal poverty level.

The Pharmaceutical Research and Manufacturers of America [PRMA] studies show 75 percent of physicians frequently or sometimes give out samples to help patients with out-of-pocket costs, while many poorer and uninsured folks never get to see a doctor and/or more often visit public health clinics or emergency rooms, where samples may not be available.

Assessment

Or, they forego care!

And so, what is your opinion on this finding; malicious or merely absent-minded?

Conclusion

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Dictionary of Health Economics and Finance
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Filed under: Drugs and Pharma | Tagged: Big Pharma and Drugs | 6 Comments »

Pharma Ties Common in Medical Schools

Posted on January 12, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Study Economically Links Medical Leaders to Industry

By Staff Reporters

A new study suggests that nearly two of three academic leaders surveyed at US medical schools and teaching hospitals have financial ties to the pharmaceutical industry, illustrating how pervasive these relationships have become; researchers say.

Assessment

This link to a related report was sent in by a reader-advocate, with our thanks: http://www.msnbc.msn.com/id/21333262

Conclusion: Now, is anyone really surprised? Your comments are appreciated.

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Filed under: Drugs and Pharma | Tagged: Big Pharma and Drugs | 2 Comments »

Medicare Prescription Drug Benefit Outcomes

Posted on January 11, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

Annals of Internal Medicine [AIM] Study on Part D

[By Staff Writers]

The AIM recently reported from its online survey that Medicare Part D induced a 13.1 % decrease in out-of-pocket expenses for patients and a 5.9 % increase in prescription drug use.

The study compared out-of-pocket costs and the number of pills purchased by those who were eligible for Part D – with comparable patients who were not. It also compared Part D members to patients who were eligible for, but did not enroll in, Medicare Part D.

The program saved pre May 15, 2006 members about $6 per month and gave them an extra three to four days worth of one medicine per month.

After the enrollment deadline, average savings among all eligible seniors increased to about $9 a month with 14 extra days of medicine per month. The study also found that patients who enrolled early in the Part D program and higher rates of utilization and out-of-pocket costs prior to the Part D period and stood to benefit most from enrollment.

Assessment

And so, what are your thoughts on these results, first reported by Newswise on January 8, 2008?

Conclusion

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[HEALTH INSURANCE, MANAGED CARE, ECONOMICS, FINANCE AND HEALTH INFORMATION TECHNOLOGY COMPANION DICTIONARY SET]

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

***

Filed under: Drugs and Pharma | Tagged: Big Pharma and Drugs | 2 Comments »

Honoraria Controversy – Ties that Bind

Posted on December 13, 2007 by Dr. David Edward Marcinko MBA MEd CMP™

Pharmaceutical / Medical Device Industry Bedfellows

By Staff Writers

The Journal of the American Medical Association recently reported that nearly two-thirds of academic leaders surveyed at 125 US medical schools and the nation’s 15 largest teaching hospitals have financial ties to the medical industry.

Serving as paid consultants or thought leaders – accepting industry money for free meals, honoraria and drinks were among the most common practices reported by the heads of academic departments.

Moreover, researchers said drug companies and makers of medical devices often use these connections to influence doctors to use products that aren’t necessarily in the patient’s best interest.

Overall, 60 percent of department heads reported some type of personal financial relationship with the industry, while 27 percent said they had recently served as a paid consultant.

The same percentage reported serving on a company scientific advisory board, and 21 percent who headed departments of medical specialties closely related to patient care said they had served on speakers’ bureaus for industry.

And so, is this ethical or acceptable to you; or just standard industry practice?

Filed under: Drugs and Pharma | Tagged: Big Pharma and Drugs | 1 Comment »

2008 – 2014 Medicare Part D Rates

Posted on December 9, 2007 by Dr. David Edward Marcinko MBA MEd CMP™

Premium Increases for Seniors

[By Staff Writers]

Medicare Past D, the prescription drug benefit set forth under the MMA is variable by the plan vendor, with premium rates set on an annual basis.

Cost sharing is subsidized for qualified Medicaid/Medicare crossovers and specified low-income beneficiaries. The MMA allows for the deductible and variable coinsurance coverage levels to increase on an annual basis in subsequent years.

The standard benefit and cost sharing for 2008 is:

· Annual Deductible of $275;

· 25% Coinsurance for covered drugs costs between $276 and $2,510;

· 100% Coinsurance (no plan coverage) of the cost of covered drugs between $2,511 and $5,726.25;

· The Maximum beneficiary annual out of pocket, which determines the upper limit of no plan coverage as stated above is $4,050; and

· 5% coinsurance of the cost of covered drugs above $5,726.25 (or a co-payment of $2.25 for covered generics and $5.60 for covered brand-name drugs-whichever is greater).

Assessment

Now, in accordance with the Medicare Modernization Act, single beneficiaries and married couples with annual incomes exceeding a specified amount now pay a higher percentage of the cost of Medicare Part B coverage, through the Part B premium.

These higher-income beneficiaries will pay a monthly premium equal to 35, 50, 65, or 80% of the total cost, depending on their income level, by the end of the 3-year transition period that started in 2007.

Conclusion

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Filed under: Drugs and Pharma | Tagged: Big Pharma and Drugs | 5 Comments »

Fewer Drugs for the Old Folks

Posted on December 8, 2007 by Dr. David Edward Marcinko MBA MEd CMP™

Medicare Part D

[By Staff Writers]

The CMS reported in USA Today that Medicare beneficiaries are likely to see a smaller number of drugs covered under Part D plans next year, as insurers revise offerings and the government reduces hundreds of products from a list of approved drugs.

On average, the number of drugs offered by the 10 insurers with the largest enrollment shrank by 26 percent from this year to next. Two of the largest insurers – UnitedHealth and Humana – saw drops of 30 percent in some of their plans, from more than 3,750 drugs to just more than 2,620. The drop came mainly because of changes made by Medicare, which shrank the list of drugs it will pay for – reducing those that have been pulled by the FDA, are no longer being made, had duplicative billing codes or were drugs deemed “less than effective”.

Medicare officials and insurers opine that most beneficiaries are unlikely to be affected, and that enrollees taking drugs that were pulled will usually be able to find alternates, or can go through an appeals process to try to stay on their current drugs.

And so, do “fewer covered drugs” help or hurt Medicare D recipients?

Conclusion

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Filed under: Drugs and Pharma | Tagged: Big Pharma and Drugs | 1 Comment »

The Pharmaceutical Industry

Posted on December 8, 2007 by Dr. David Edward Marcinko MBA MEd CMP™

Prognosis for Big Pharma

[By Staff Writers]

According to the Wall Street Journal, generic drug competition is expected to wipe $67 billion from top pharmaceutical companies’ annual U.S. sales between 2007 and 2012.

Why? More than three dozen drugs lose patent protection; roughly half of the companies’ combined 2007 U.S. sales.

Moreover, during the five years from 2002 through 2006, the industry brought to market 43 percent fewer new chemical-based drugs than in the last five years of the 1990s, despite doubling R&D spending.

Assessment

And so, what do you think about this grim prognosis for big pharma as patents expire and the industry is failing to find new drugs to replace existing ones?

***

Filed under: Drugs and Pharma | Tagged: Big Pharma and Drugs | 3 Comments »

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Study Economically Links Medical Leaders to Industry

By Staff Reporters

A new study suggests that nearly two of three academic leaders surveyed at US medical schools and teaching hospitals have financial ties to the pharmaceutical industry, illustrating how pervasive these relationships have become; researchers say.

Assessment

This link to a related report was sent in by a reader-advocate, with our thanks: http://www.msnbc.msn.com/id/21333262

Conclusion: Now, is anyone really surprised? Your comments are appreciated.

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