Medicaid, Medicare and YOU!

 

The following is an article from online, FOX NEWS and commentary:

 

Taxpayers have shelled out at least $200 million since 2004 for medications that have never been reviewed by the government for safety and effectiveness but are still covered under Medicaid, an Associated Press analysis of federal data has found. Millions of private patients are taking such drugs, as well

BV: TAXPAYERS ARE PATIENTS, PATIENTS, PARTICULARLY ONES ON MEDICAID AND MEDICARE DO NOT HAVE EXTRA BUCKS FOR THE LATEST GREATEST DRUGS. I have spoken on this previously, if not directly then by implication.

IF our HEALTHCARE SYSTEM were viable, reliable and worthy of praise, we would say, " Let us CooPeratively purchase drugs as a national program. If we reformed healthcare, "coop-ing" in this way, drug companies with medicare, mediciad who knows? Maybe we would live better, feel stronger and live longer? IT's a thought…

You are Saying "NO" to this suggestion or scheme? Are you saying, "But NO! NOT "US" we want to pay more and get less?"Well you are paying more that some, and you might be risking your in life doing it, or so this article implies such a potential threat. WHAT DO WE DO? PUT ON OUR THINKING CAPS, AND GET STARTED. WRITE IN PENCILE IF IT MAKES YOU FEEL BETTER..

Ok, Wipe the slate clean, start from scratch, Priority 1: Healthcare : Do you have a doctor who you consistently see personally when you are sick? Does your doctor know you? When they write you a prescription do you know what your taking? We can't leave it all up to the doctor and the pharmacist; we know what makes our colds, aches and pains go away, and we are just as responsible for our care, no more-so responsible as the doctor and pharmacist. Being privy to new information on drugs is also our responsibility as patients. (Knowing for example that you cannot take certain pain killers, that aver the counter with some prescriptions is essential) .

Too many people, myself included, jus t say, "I need more of those blue caps for my stomach," and that's as far as it goes, knowledge-wise on pharmaceutical ,drugs.

Simultaneously:

IF our system were serving us well, we would have: Priority 2: An integrated health and behavioural health system, online. Online would be: your access to your records, pin, password secure, and an interface between your doctor's records, rx, and prognosis and care records. The interface with the paying agency: your healthcare provider, Oxford Health Plans, United Health Care or whatever your plan is. The one paying the bill would have direct access to the care-giver to exchange equally the progress, cause and provide more than just payment of bills. Medicare, as a government agency, regulating healthcare for consumers, old and poor and disABLED should notify Doctors of changes in the status of drugs and therapies, and vice versa toward them.

(I hope your not getting a bad impression because, I Don't think I know exactly WHAT DOES AND DOES NOT NEED TO BE DONE, but I'm willing to go out and PROSPOSE and idea for a "Circuit" of healthcare in America. OTHERS WHO READ-IN CAN ADD TO OR EXTRAPOLATE ON THESE IDEAS? I HOPE…)

This is how it would go:

1. You are sick and you go to the doctor.
   
2. The doctor says that you have irritable bowel and writes prescriptions for you for five medications. Your prognosis is good because the meds work.
   
3. A)Your doctor accepts co-pay, then files a claim, electronically with for example, Oxford Healthplans'. B) Oxford forwards the claim information to Medicare, or Medicaid , your provider. C) You get a record of the transaction. And the records should stay on file 3-5 years and then be micro-filmed.
   
4. The Doctor's office inputs the claim directly to Oxford, and the Medicaid and Medicare offices get notified as to what relates to your health, mental of physical. (YOULL have to decide: Do you want everything via social security number, pin number, alpha-numeric or all of the above…these are small details) When You apply for work, there should also be an interface with social security, there is I believe to some degree information from the States relating to pay, but the details as to what work? Are not found…
   

ON with the article….

The availability of unapproved prescription drugs to the public may create a dangerous false sense of security. Dozens of deaths have been linked to them.

The medications date back decades, before the Food and Drug Administration tightened its review of drugs in the early 1960s. The FDA says it is trying to squeeze them from the market, but conflicting federal laws allow the Medicaid health program for low-income people to pay for them.

BV: Make medications affordable and people won't be looking for one's that are cheaper, "generic," or "new and promising results". Simply: people won't take chances they don't have to if they believe they may be harmed.

The truth is: Medications are too expensive, testing takes too long and people become lab test's results, sometimes we find out after someone has died from a drug that it was a drug that should be removed from our marketplace.

IF we purchased medications cheapest, with best results and tested/approved there would not be so much horror, here or elsewhere.

Proposal, solution and starting point: Make drug companies partner with drug chains: IN effect, Cooperative operations: It goes back to an integrated approach, namely have CVS, or whomever your drug store is, purchase cheaper, by purchasing in bulk, in a partner contact to supply xyz for x amount of time, and make both parties stick to it.

It's a business deal, something I don't like in healthcare at all…

These are called, "Blanket Orders" Because the give us security and they cover a particular item> Research, Planning and Scheduling IN TIME usage for a specified period of time.

I have written about this elsewhere…

Back to the article

The AP analysis found that Medicaid paid nearly $198 million from 2004 to 2007 for more than 100 unapproved drugs, mostly for common conditions such as colds and pain. Data for 2008 were not available but unapproved drugs still are being sold. The AP checked the medications against FDA databases, using agency guidelines to determine if they were unapproved. The FDA says there may be thousands of such drugs on the market.

BV: IF the system, Doctor, pharmacist and client 1) know how a drug is helping or not 2) the pharmacists can get the drugs cheap 3) the consumer is educated about what OTHER options there are 4) The health provider relates what has been taken off the market to the Doctors and pharmacists, we would curtail much!

CRUX of Article?

Medicaid officials acknowledge the problem, but say they need help from Congress to fix it. The FDA and Medicaid are part of the Health and Human Services Department, but the FDA has yet to compile a master list of unapproved drugs, and Medicaid -- which may be the biggest purchaser -- keeps paying.

 

BV: IF an informed consumer, their doctor and the health plan agree that they will fore-go safety, (For say an experimental AIDS drug), they sign an affidavit saying so. Then Medicaid, and Health providers have spoken).

Article continued….

"I think this is something we ought to look at very hard, and we ought to fix it," said Medicaid chief Herb Kuhn. "It raises a whole set of questions, not only in terms of safety, but in the efficiency of the program -- to make sure we are getting the right set of services for beneficiaries."

At a time when families, businesses and government are struggling with health care costs and 46 million people are uninsured, payments for questionable medications amount to an unplugged leak in the system.

Sen. Charles Grassley, R-Iowa, has asked the HHS inspector general to investigate.

BV: Mr. Grassley, keep up the good fight for us all…

Continuing;

That unapproved prescription drugs can be sold in the United States surprises even doctors and pharmacists. But the FDA estimates they account for 2 percent of all prescriptions filled by U.S. pharmacies, about 72 million scripts a year. Private insurance plans also cover them.

The roots of the problem go back in time, tangled in layers of legalese.

It wasn't until 1962 that Congress ordered the FDA to review all new medications for effectiveness. Thousands of drugs already on the market were also supposed to be evaluated. But some manufacturers claimed their medications were "grandfathered" under earlier laws, and even under the 1962 bill.

Then, in the early 1980s, a safety scandal erupted over one of those medications. E-Ferol, a high potency vitamin E injection, was linked to serious reactions in some 100 premature babies, 40 of whom died.

In response, the FDA started a program to weed out drugs it had never reviewed scientifically. Yet some medications continued to escape scrutiny.

Sometimes, the medications do not help patients. In other cases, the FDA says, they have made people sicker, maybe even killed them. This year, for example, the FDA banned injectable versions of a gout drug called colchicine after receiving reports of 23 deaths. Investigators found the unapproved drug had a very narrow margin of safety, and patients easily could receive a toxic dose leading to complications such as organ failure.

Critics say the FDA's case-by-case enforcement approach is not working.

"The FDA does not appear to have a systematic mechanism to report these drugs out," said Jon Glaudemans, senior vice president of Avalere Health, a health care industry information company, "and there doesn't seem to be a systematic process by which health insurance programs can validate their status. And everyone is pointing the finger at someone else as to why we can't get there."

BV: The process will only take place when we all share information, records, prognosis' and best drug therapies….and not until then…in the interim we have to reform "THE SYSTEM" itself.

'Further, the article says:

In most cases, doctors, pharmacists and patients are not aware the drugs are unapproved.

"Over the years, they have become fully entrenched in the system," said Patti Manolakis, a Charlotte, N.C., pharmacist who has studied the issue. Only a few unapproved drugs are truly essential and should remain on the market, she added.

Tackling the problem is made harder by confusing -- and sometimes conflicting -- laws, regulations and responsibilities that pertain to different government agencies.

BV: Progress is sometimes made by bold individuals, or desperate ones, who find out first person whether a drug is effective….

The article continues….

Medicaid officials said their program, which serves the poor and disabled, is allowed to pay for unapproved drugs until the FDA orders a specific medication off the market. But that can take years.

Compare that with Medicare, the health care program for older people.

Medicare's prescription program is not supposed to cover unapproved drugs. Medicare has purged hundreds of such medications from its coverage lists, but continues to find others.

BV: BINGO! Somebody agrees with me. You were listening to me?

'Further on the article states….

It might be easier to sort things out if the FDA compiled a master list of unapproved drugs, but the agency hasn't. FDA officials say that would be difficult because many manufacturers do not list unapproved products with the agency. Yet, the AP found many that were listed -- a possible starting point for a list.

Among the drugs the AP's research identified were Carbofed, for colds and flu; Hylira, a dry skin ointment; Andehist, a decongestant, and ICAR Prenatal, a vitamin tablet. Medicaid data show the program paid $7.3 million for Carbofed products from 2004 to 2007; $146,000 for Hylira; $4.8 million for Andehist products, and $900,000 for ICAR.

Grassley said the system is failing taxpayers and consumers.

"The problem I see is bureaucrats don't want to make a decision," Grassley said. "There is no reason why this should be such a house of mirrors when so much public money is being spent." Grassley is considering introducing legislation to ensure that consumers are told when a medication is unapproved.

FDA officials say they tell Medicaid and Medicare when the agency moves to ban an unapproved drug, so the programs can stop paying.

"The situation is complicated by the fact that Medicaid and Medicare have a different regulatory regime than FDA does," said FDA compliance lawyer Michael Levy. "There are products that we may consider to be illegally marketed that could be legally reimbursed under their law."

BV: As you and I know, the US is often a policeman, but cannot regulate other countries or impede therapies.

For instance, the article says….

The FDA began its latest crackdown on unapproved drugs two years ago and has taken action against nine types of medications and dozens of companies. Typically, the agency orders manufacturers to stop making and shipping drugs, and it also has seized millions of dollars' worth of medications. But federal law does not provide fines for selling unapproved drugs, and criminal prosecutions are rare.

Some manufacturers of unapproved drugs say their products predate FDA regulation and are "grandfathered in."

BV: This is of particular interest, because essential chemicals may not cause a problem, but a NEW-combination might have a significantly adverse effect!

We go back to this article….

"These are drugs that don't require an FDA approval," said Bill Peters, chief financial officer of Hi-Tech Pharmaceutical in Amityville, N.Y. "These are products with active ingredients that have been on the market for a long time." The company is moving away from older products, Peters said, and its new market offerings are FDA-approved.

Levy said the FDA is skeptical that any drugs now being sold are entitled to "grandfather" status. To qualify, they would have to be identical to medications sold decades ago in formulation and other important aspects.

The agency is targeting drugs linked to fraud, ones that do not work and, above all, those with safety risks. While the crackdown has helped, it does not appear to have solved the problem.

The gout drug banned by the FDA this February is not the only recent case involving safety problems.

Last year, the FDA banned unapproved cough medicines containing hydrocodone, a potent narcotic. Some had directions for medicating children as young as age 2, although no hydrocodone cough products have been shown to be safe and effective for children under 6.

In a 2006 case, the agency received 21 reports of children younger than 2 who died after taking unapproved cold and allergy medications containing carbinoxamine, an allergy drug that also acts as a powerful sedative. Regulators banned all products that contained carbinoxamine in combination with other cold medicines.

"We as Americans have a belief that all the prescription drugs that are available to us have been reviewed and approved by the FDA," said Manolakis, the pharmacist. "I think the presence of these drugs shows we have a false sense of security."

Bv: Make healthcare's priority HEALTH and Not PROFITS, COMBINE EXPERTISE OF VARIOUS INDIVIDUALS: DOCTORS TO PHARMACISTS, AND HEALTH CARE PROVIDERS TO THEM ALSO, A CONTINUING DELIVERY OF CARE, PROGRESS AND EFFICIENTCY.