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What Will Vaccine Liability Waivers Mean For The Covid-19 Inoculation

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What Will Vaccine Liability Waivers Mean For The Covid-19 Inoculation. There will be issues with the new Coronavirus/Covid-19 vaccine because there were issues with every single vaccine introduced before. There are currently numerous studies and trials devoted to finding a shot that will give immunity to the recipient against the deadly and contagious Coronavirus/Covid-19 pandemic. The company that is first to introduce a successful shot for immunity will reap big rewards in the form of profits and scientific prestige. But when there are problems with it, as there certainly will be, what recourse does the public have?

Vaccine Liability Photo
Vaccine waivers protect manufacturers from lawsuits and liability other drugs have.

On his regular podcast, respected neurologist Dr. Steven Goldstein describes the risks and benefits of vaccines and a regulation known as the ‘vaccine liability waiver.’ The Houston Healthcare Initiative Podcast can be heard on SoundCloud, LibSyn, Google Play, iHeartRadio, iTunes, Stitcher, Radio.com and many other places where podcasts are heard.

What Is The Vaccine Liability Waiver?

According to Dr. Goldstein, vaccine liability waivers are really what the name implies which is that vaccine makers are not generally held responsible for injuries their vaccines may cause. “This is notable because it is the only part of the healthcare industry where such protection exists,” Dr. Goldstein told his listeners. “The companies that make these vaccines cannot be sued for monetary damages unless a person who died or was seriously injured can demonstrate that the company engaged in “willful misconduct” which is a very high legal standard to achieve.”

The Vaccine Waiver Makes Vaccines Possible

What Will Vaccine Liability Waivers Mean For The Covid-19 Inoculation? It is very likely that were it not for the ‘waiver’ there would be few if any vaccine makers in the U.S. Starting with the Salk vaccine in the 1950’s through the 1970’s and ‘80’s, lawsuits against vaccine makers increased to the point that there was only one Diphtheria Pertussis Tetanus (DPT) vaccine maker in the U.S.

In 1986 the U.S. Congress responded to the situation in the vaccine market by passing the ‘National Childhood Vaccine Injury Act’ or NCVIA. The act included a number of regulations related to informed consent and adverse event reporting but also removed many of the monetary recovery options that were putting the industry out of business.

Complexity Comes With Safeguards

Vaccines are developed, tested, and regulated the same as other drugs but more so. Vaccine development is a complex process that takes usually takes years. That is because the number of people in vaccine clinical trials are usually greater, and, those who receive vaccines are more in number than those who receive or take other prescription drugs. In addition, post-license monitoring of vaccines is closely examined by the Centers for Disease Control (CDC) and the Food & Drug Administration (FDA).

So, while the liability waiver exists, all the other pharmaceutical safeguards are in place. Regardless of expectations, no medical treatment is completely risk free. “Vaccines are made to protect us from disease, but they can have negative side effects,” Dr. Goldstein said. “Most of these effects are pretty mild like soreness in the arm from the injection. Others can be more serious. But without these rules it is unlikely anyone in the U.S. would be researching a Covid-19 vaccine.”

What Will Vaccine Liability Waivers Mean For The Covid-19 Inoculation? Nothing in the world of medicine is without risk and the ultimate introduction of the Coronavirus vaccine is no exception. The laws and regulations strike a balance that protects the public and aids in the delivery of a vaccine sooner than later.

The Effectiveness Standard for Covid-19

The minimum requirement by the Food and Drug Administration (FDA) for any COVID-19 vaccine is that it should at least prove 50% effective when compared with a placebo — that is, a neutral saline solution. The annual flu vaccine is a success when it is 40% – 60% effective. Fifty percent is right in the same range as the flu vaccine.

About The Houston Healthcare Initiative

Dr. Steven Goldstein is a Houston based neurologist. He founded the Houston Healthcare Initiative and is an advocate for common sense solutions to the healthcare crisis that confronts the citizens and residents of the United States of America.

 

Is Healthcare a Right?

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When we talk about rights in the American tradition, we generally are considering things that citizens enjoy that the government cannot take away, as enumerated in the Bill of Rights. The first amendment, for example, says that Congress “shall make no law” concerning the free exercise of religion, speech, press, and the right to peacefully assemble and petition the government to redress grievances.

Is Healthcare a Right?

However, when we talk about the right to healthcare, we mean that everyone should be able to access medical services regardless of the ability to pay. The “right to healthcare” becomes a little tricky since someone has to pay, if not the patient. Most advocates who call for the right to healthcare believe that the government should pay for it in some manner.

The problem is that a couple of states have attempted to enact single-payer healthcare, only to fail when the question of funding arose. Vermont, the home state of Sen. Bernie Sanders, a well-known advocate for a government guarantee for the right to healthcare, failed to enact such a system when the amount and method of taxation to pay for it arose.  An attempt to enact single-payer healthcare in California failed for similar reasons.

Sadly, no country on Earth guarantees healthcare as a right, not even Canada, as a recent piece in the Washington Times by Roger Stark pointed out.  Stark is a healthcare policy analyst and physician. Canadians have the right to healthcare insurance, which is a distinction that makes quite a bit of difference. Sick Canadians must often await healthcare services for months, a delay that would be unacceptable to most Americans.

Stark suggests a free-market solution to providing the most people the greatest amount of healthcare possible. But would such a system guarantee healthcare for all, which everyone across the political spectrum regards as a worthy goal?

For more information contact us.

The right mix of policies, from a free market to a government guarantee, would be a tricky one to enact and would not constitute a simple solution.

Off Label Prescriptions Removed From The Table Overly Zealous Watchdogs Interfere with Patients and their Doctors

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Off Label Prescriptions Removed From The Table….

Overly Zealous Watchdogs Interfere with Patients and their Doctors

October 1, 2020 – Does a physician or the pharmacist know what is best for a patient? When the Ohio

Off Label Prescriptions Removed From The Table…. Overly Zealous Watchdogs Interfere with Patients and their Doctors October 1, 2020 – Does a physician or the pharmacist know what is best for a patient? When the Ohio Board of Pharmacy ruled that doctors could not prescribe the off-label treatment hydroxychloroquine to treat the Coronavirus/Covid-19 pandemic it was a chilling trespass into the rights of people in Ohio and set a dangerous precedent in the other forty nine. Medicines to treat conditions with off-label prescribing occurs when a physician stipulates a drug that the U.S. Food and Drug Administration (FDA) has approved to treat a condition different than what a patient has. Off label prescribing is nothing new. Unanticipated Consequences of Overly Aggressive Regulators This practice is legal and common as one in five prescriptions written today are for off-label use. The Ohio Board of Pharmacy decision was without precedent. Americans should be nervous about this instance because it puts the relationships between doctors and patients at risk and removes the judgement of physicians about how to best treat their patients, putting it into the hands of government regulators. “This overreach is a present and future danger for Americans and their doctors in the wake of the Coronavirus/Covid-19 pandemic,” Dr. Steven Goldstein told the audience on his podcast. “This puts decision making about how best to treat a patient into the hands of someone who does not know the individual, never mind has any medical experience with them.” The Future Beyond Covid-19 The prospect that someone other than the doctor and patient are involved in this decision making is bad practice. “Doctors are trained and educated to diagnose and treat patients”, Dr. Goldstein said. “They also have experience treating their patients and know how to evaluate scientific papers about new treatments. Pharmacists and government bureaucrats do not have this training or experience.” In the case of hydroxychloroquine there is no randomized controlled trial to prove scientifically whether or not this drug is effective for Covid-19. It is also true that there is no other treatment that has been proven with a randomized controlled trial to be effective. “Physicians should be able to use any treatment that may be beneficial to their patient,” Dr. Goldstein said. “Interference by government boards or other non-physicians will retard the development of effective treatments and lead to additional mortality and morbidity.” The next outbreak is a certainty, it’s only a matter of time. “If pharmacists and bureaucrats are getting between doctors and patients now, we should be very worried about the future,” Dr. Goldstein concluded. About the Houston Healthcare Initiative Podcast The Houston Healthcare Initiative podcast with Dr. Steven Goldstein is an information vehicle for people who want to know all medical options for themselves and are interested in reforming the healthcare industry. To hear the podcast go to: SoundCloud, iHeartRadio, Stitcher, Backtracks, LibSyn, or the website at www.houstonhealthcareinitiative.org. Dr. Goldstein insists that for the health and welfare of the American public, the congress must pass reforms that limit the influence of the pharmaceutical industry and its lobby.
Overly Zealous Watchdogs Interfere with Patients and their Doctors.

Board of Pharmacy ruled that doctors could not prescribe the off-label treatment hydroxychloroquine to treat the Coronavirus/Covid-19 pandemic it was a chilling trespass into the rights of people in Ohio and set a dangerous precedent in the other forty nine.  Medicines to treat conditions with off-label prescribing occurs when a physician stipulates a drug that the U.S. Food and Drug Administration (FDA) has approved to treat a condition different than what a patient has. Off label prescribing is nothing new

Unanticipated Consequences of Overly Aggressive Regulators

This practice is legal and common as one in five prescriptions written today are for off-label use. The Ohio Board of Pharmacy decision was without precedent. Americans should be nervous about this instance because it puts the relationships between doctors and patients at risk and removes the judgement of physicians about how to best treat their patients, putting it into the hands of government regulators. “This overreach is a present and future danger for Americans and their doctors in the wake of the Coronavirus/Covid-19 pandemic,” Dr. Steven Goldstein told the audience on his podcast. “This puts decision making about how best to treat a patient into the hands of someone who does not know the individual, never mind has any medical experience with them.”

The Future Beyond Covid-19

The prospect that someone other than the doctor and patient are involved in this decision making is bad practice. “Doctors are trained and educated to diagnose and treat patients”, Dr. Goldstein said. “They also have experience treating their patients and know how to evaluate scientific papers about new treatments. Pharmacists and government bureaucrats do not have this training or experience.

In the case of hydroxychloroquine there is no randomized controlled trial to prove scientifically whether or not this drug is effective for Covid-19. It is also true that there is no other treatment that has been proven with a randomized controlled trial to be effective. “Physicians should be able to use any treatment that may be beneficial to their patient,” Dr. Goldstein said. “Interference by government boards or other non-physicians will retard the development of effective treatments and lead to additional mortality and morbidity.” The next outbreak is a certainty, it’s only a matter of time. “If pharmacists and bureaucrats are getting between doctors and patients now, we should be very worried about the future,” Dr. Goldstein concluded.

About the Houston Healthcare Initiative Podcast

The Houston Healthcare Initiative podcast with Dr. Steven Goldstein is an information vehicle for people who want to know all medical options for themselves and are interested in reforming the healthcare industry. To hear the podcast go to: SoundCloud, iHeartRadio, Stitcher, Backtracks, LibSyn, or the website at www.houstonhealthcareinitiative.org. Dr. Goldstein insists that for the health and welfare of the American public, the congress must pass reforms that limit the influence of the pharmaceutical industry and its lobby.

 

 

Federal Government Goofs Delayed Coronavirus Tests By 6-8 Weeks

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The United States badly bungled coronavirus testing.
The United States badly bungled initial coronavirus testing. Federal Government Goofs Delayed Coronavirus Tests By 6-8 Weeks.

Federal Government Goofs Delayed Coronavirus Tests By 6-8 Weeks. On his regular podcast Dr. Steven Goldstein described how failures within the federal government delayed proper testing for the Coronavirus/Covid-19 virus by several weeks.  The outcome? Tracking and tracing the infection early in the process was impossible. The Houston Healthcare Initiative Podcast is available on SoundCloud, iHeartRadio,LibSyn, Spotify,  iTunes, Radio.com, Stitcher, ListenNotes, Podcast Addict, or the Houston Healthcare Initiative web site.

Early Kit Troubles

Early in the testing process the Food and Drug Administration (FDA) sent Coronavirus/Covid-19 test kits to approximately 100 health labs across the country. Initially the FDA had done all the testing in in-house, but more cases meant that tests had to be available in more locations. There was just one, very important mistake and that was there was no way to validate the tests and its ingredients all acted the same way when used, regardless of the location.

Thirty-six of the approximately 50 tests returned results to the FDA that were ‘inconclusive’. Manufacture of new ingredients for the tests took 3 weeks. The failure to get working test kits into public-health labs came at a really bad time. Early in any outbreak, contact tracing, isolation, and individual quarantines are used to contain the spread of disease. These steps don’t work when suspected cases cannot be tested. The gap made by the bad test kits made it impossible for public-health officials to get a read on how far and fast the disease was spreading. The result, Covid-19 spread undetected for several weeks. “The government was not prepared when it came to identifying and quarantining contacts of the first patients and preventing sick patients from entering the country,” Dr. Goldstein told his listeners. “Government bureaucracy delayed the development of laboratory tests for 6-8 weeks.”

Worse still, when an Emergency Use Application (EUA) test was sent via email and followed up with phone calls from the University of Washington Virology Lab to the FDA for approval, the applicants learned that U.S. law required a hard copy of the applications be sent with a CD or thumb drive via the U.S. Postal Service to be considered. Instead of using more advanced communications like e-mail the lab was forced to use ‘snail mail’. (The F.D.A. has since dropped the requirement to send a CD-rom or USB drive with a copy of the application).

Bureaucrats Want More Power Not Less

According to Dr. Goldstein, issues like this have more to do with the bureaucratic class maintaining its influence than protecting the public or any devotion to science. “People ensconced in government bureaucracy want to preserve their authority and it seems that they are willing to take drastic measures to preserve that power,” Dr. Goldstein said. “These people are very invested in expensive, high tech treatments. Low tech measures like contact tracing and quarantining and testing anyone entering the country could have controlled the epidemic early on.” One possible lesson from this is to remember that government takeover of any health crisis will persist long past any benefit is exhausted. Finding ways around these career government employees should be part of any proposed reform for the healthcare industry.

About the Houston Healthcare Initiative

Dr. Steven Goldstein is a Houston based neurologist. He founded the Houston Healthcare Initiative and is an advocate for common sense solutions to the healthcare crisis that confronts the citizens and residents of the United States of America. Federal Government Goofs Delayed Coronavirus Tests By 6-8 Weeks.

 

Healthcare and Telemedicine

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Healthcare IT News is reporting that the Health and Human Services Department has released a document that addresses the unique problems facing healthcare providers and patients in rural America. A crucial part of the Rural Action Plan involves distance or telemedicine, in which healthcare providers consult with patients over a two-way computer network.

Healthcare and Telemedicine

Rural America has had a longstanding lack of readily available doctors and hospitals. People living outside of large population centers often must travel great distances to acquire face-to-face care. Telemedicine is one tool meant to alleviate that problem and get more healthcare services to underserved rural patients.

The federal government’s current budget proposal for Medicare would separately value telemedicine services from their equivalent face-to-face services. In this way purveyors of distance medicine will be more readily ensured reimbursement for their services.

The budget will also allow federally qualified healthcare providers and rural health centers to offer telehealth services, making permanent an arrangement that is temporary because of the coronavirus pandemic. The role of the Office for the Advancement of Telehealth will be elevated to become a focal point for coordinating telemedicine services across the government and the private sector.

One barrier to expanding telemedicine across rural America has been a lack of broadband internet services outside of big cities. Fortunately, the private sector seems to be stepping up, in particular Elon Musk’s SpaceX with the development of the Starlink satellite constellation. Starlink is designed to provide direct-from-space audio, visual, and data communications services to everyone on the planet, with services for North America (the United States and Canada) due to be available in 2020. The service will expand world-wide the following year.

Telemedicine’s expansion is thought to be a vehicle to expand healthcare services and enhance outcomes to millions of hitherto under-serviced people.

For more information contact us at Houston Healthcare Initiative.

Best Selling Author Gerald Posner Discusses ‘Pharma: Greed Lies and Poisoning of America’

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Gerald Posner on the podcast this week.
Gerald Posner latest work is “Pharma: Greed, Lies, and the Poisoning of America.” This book describes something we here are all very interest in which is the history of the pharmaceutical manufacturing industry.

In a special edition of the Houston Healthcare Initiative podcast best-selling author and investigative journalist Gerald Posner discusses the sordid history of the drug business from his most recent work, ‘Pharma: Greed Lies and the Poisoning of America.’ It reads like a ‘true crime’ novel, though everything in the volume is true. ‘Pharma: Greed Lies and the Poisoning of America’ is available at Amazon, just click here: ‘Pharma: Greed Lies and the Poisoning of America.’

The Houston Healthcare Initiative podcast can be heard on SoundCloud, iTunes, iHeartRadio, LibSyn, Spotify, and the Houston Healthcare Initiative web site. In the book and podcast Posner tells a compelling story that links the history of the pharmaceutical industry from the mid-19th century to the twenty first. It is not a flattering narrative. Many of the practices that were incorporated into marketing and selling heroin and cocaine in the early 20th century were and are still used today. And like they did before, the same companies are deliberately downplaying of the risk of modern-day medicines like opioids that have led to addiction and death for so many Americans.

Interests Intersect

Mr. Posner’s work and the interests of the Houston Healthcare Initiative coincide in several important ways. “The reform of the entire healthcare industry including the pharmaceutical business is our mission,” said Dr. Steven Goldstein who founded the Houston Healthcare Initiative. “We were very flattered he took time to talk with us and the audience about this important topic and we hope that everyone who reads his new book is inspired to act.”

Profits, Then Everything Else

Marketing, sales, advertising and abuse of patent law are all used against the American public to boost sales and stock prices of drug companies. This is part of the historic heritage that links the business’ past to today. “Only by knowing its history,” Mr. Posner writes, “is it possible to fully appreciate how the battle between noble ambitions and greed is a permanent conflict.” Mr. Posner tells many stories about the people behind the industry and the some of the ethically questionable things they did and still do.

Meet the Sacklers

The mindset of these and other actors id’ed in the book can be better understood with one of many informative stories Mr. Posner relates. According to Mr. Posner, eight people in a single family ‘made the choices that caused much of the opioid epidemic.’ The family in question is the Sacklers, notably Arthur, who “had some clever ideas of how to disguise product promotions as ‘news’ covered in consumer press.” According to media experts, the ad made to look like news or ‘advertorial’ is a really low rung on either the paid ad or public relations ladder.

Nazis? Really?

Mr. Posner detailed this during his interview on the podcast. “In 1947, defense attorneys for Nazi doctors charged with war crimes for human experimentation at concentration camps cited the malaria experiments in a failed effort for an acquittal. He went on, “when Nazi doctors are citing clinical trials from your industry as grounds for an acquittal in their own legal trials, you have erred.”

To learn more about Gerald Posner visit his web site at https://www.posner.com/.

About Houston Healthcare Initiative And Dr. Steven Goldstein

Dr. Steven Goldstein is a Houston based neurologist. He founded the Houston Healthcare Initiative and is an advocate for common sense solutions to the healthcare crisis that confronts the citizens and residents of the United States of America.

 

 

 

Pharma: Greed Lies and the Poisoning of America

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Gerald Posner on the podcast this week.

On this special edition of the Houston Healthcare Initiative podcast, author Gerald Posner discusses the history of the pharmaceutical industry and his new book “Pharma: Greed, Lies, and the Poisoning of America.” This book describes the history of the pharmaceutical manufacturing industry and how we and they got to the place we are now.

Among many shocking facts included are that many of the practices that were incorporated into marketing and selling heroin and cocaine in the early 20th century are still used today. And like before, those same companies are deliberately downplaying of the risk of modern-day medicines like opioids. Refer to www.houstonhealthcareinitiative.org and www.posner.com. Be sure to read “Pharma: Greed, Lies, and the Poisoning of America.”

Possible Remedy for the Coronavirus/Covid-19 Global Pandemic Invites Immediate Controversy

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Blood Plasma
Possible Remedy for the Coronavirus/Covid-19 Global Pandemic Invites Immediate Controversy
Treatment with blood plasma from recovered patients is an accepted practice that goes back to the early 20th century.

Possible Remedy for the Coronavirus/Covid-19 Global Pandemic Invites Immediate Controversy.

On August 23, 2020 the Food and Drug Administration (FDA) announced a decision to grant blood plasma treatment for Coronavirus/Covid-19 patients with a fast-track authorization for its emergency use as a treatment for hospitalized COVID-19 patients.

The next day, claims about the effectiveness of this treatment were retracted. Subsequent news coverage about this potential treatment did little to clarify blood plasmas’ usefulness or lack thereof. The idea that there could be a political motivation behind the fast track authorization for this potential treatment, other than looking for a useful therapeutic, is troubling.

Who Can Americans Believe?

On his regular ‘Houston Healthcare Initiative’ podcast, respected neurologist Dr. Steven Goldstein defines how this decision triggered an outcry from scientists and doctors, who said the decision was not supported by adequate clinical evidence and criticized the FDA for what was perceived as bowing to ‘political pressure’.

Dr. Goldstein also reviews those who believed this approach was worthwhile. Generally, treatment with blood plasma from recovered patients is an accepted practice that goes back to the early 20th century. Many believe the possibility that blood plasma from recovered Coronavirus/Covid-19 patients could help people fight off the virus was worthy of further investigation.

Who is correct? Who should the American public rely on for the best information about treatment for this global health emergency?

The Houston Healthcare Initiative podcast can be heard on: SoundCloud, Apple Podcasts, Stitcher, Listen Notes, iHeartRadio, and the Houston Healthcare Initiative web site.

About Houston Healthcare Initiative And Dr. Steven Goldstein

Dr. Steven Goldstein is a Houston based neurologist. He founded the Houston Healthcare Initiative and is an advocate for common sense solutions to the healthcare crisis that confronts the citizens and residents of the United States of America. Blood plasma treatment for Covid-19 patients invites controversy.

Blood Plasma Covid Treatment and Pharmaceutical Industry Reform

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Blood plasma covid treatment and pharmaceutical industry reform. On August 23, 2020 the Food and Drug Administration’s announced a decision to grant blood plasma treatment for Coronavirus/Covid-19 patients with a  fast-track authorization for its emergency use as a treatment for hospitalized COVID patients. This “emergency use authorization” triggered an outcry from scientists and doctors, who said the decision was not supported by adequate clinical evidence and criticized the FDA for what was perceived as bowing to political pressure.

Should Pharma choose people over profit?
Big Pharma has a big influence on the congress from multi-million dollar lobbying effort.

News coverage about this potential treatment has done little to clarify whether its useful or not. The idea that there could be a motivation behind the fast track authorization for this potential treatment other than looking for a useful therapeutic is troubling. More to the point, who should decide what patients receive in treatment for their illnesses? To help us make sense of how reforms for the pharmaceutical industry could potentially help separate facts from spin and who we should all listen to is respected neurologist, Dr. Steven Goldstein. Click below to listen.

To read more about this issue please click below: https://www.sciencemag.org/news/2020/08/fda-s-green-light-treating-covid-19-plasma-critics-see-thin-evidence-and-politics.

Association Healthcare Plans

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An association healthcare plan is a method of providing the advantages of a large group health insurance plan enjoyed by larger corporations, the federal government, or state governments for small businesses and individuals. Associations based on a shared profession, a line of business, or even just a geographic location, such as a state or city, can offer group health insurance with the ability to negotiate savings from healthcare providers and pharmacies. Membership in an association health insurance program also provides cost savings for premiums.

Association Healthcare Plans

Let us suppose that you are the owner of a mom and pop eatery and want to provide your employees some good health insurance, but the number of people who work for you does not rise above the threshold of a large group as defined by your state’s regulator. In that instance, a restaurant association might offer a health insurance plan for its members, with the number of premium-paying members easily being above the cutoff line of a large group, thus qualifying for savings.

If you happen to be self-employed or a freelancer, the same idea applies. Say an association of everything from accountants to freelance writers or musicians can offer an association healthcare plan, rendering tremendous savings over individual health plans.

Individual health insurance plans in the United States are very expensive and have such huge deductibles that often having such a plan is the equivalent of not having one, despite the member paying huge premiums. Association healthcare plans provide an alternative to paying through the nose for health insurance or doing without it for people who don’t work for large employers.

Health insurance reform has been a contentious political issue in the United States for decades. Association healthcare plans, in the view of many, provide at least part of an answer to getting more people affordable insurance.

For more information contact us.