42 U.S. Code § 1395 – Prohibition against any Federal interference

https://www.law.cornell.edu/us code/text/42/1395?qt-us_code_ temp_noupdates=3#qt-us_code_ temp_noupdates

Nothing in this subchapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.

(Aug. 14, 1935, ch. 531, title XVIII, § 1801, as added Pub. L. 89–97, title I, § 102(a), July 30, 1965, 79 Stat. 291.)

The information that I have received on this Federal Law is that it only applies to Medicare… Medicare covers 46 million (old age 65+) and 9 million (disabled)… so we are talking about 55 million that could possibly be covered by this law/statue.

Of course, we all know that Federal laws are enforced by the DOJ.. if which, DEA is part of.

So how many federal agencies and their employees are attempting to interfere with the medical services provided to those covered under Medicare – which should include prescriber office visits paid for by Part B and medication paid for by Part D ?

There are a number of OIG’s (Office of Inspector General) that is to oversee the legal operation of a number different federal agencies.  Where are they ?

Where is the ACLU in protecting the rights of all of these elderly/disabled Medicare beneficiaries … ?

Where is the AARP … who claims to be the “CHAMPION” for those over 50+ ?

Does this mean that the CDC did not have the LEGAL AUTHORITY to publish those opiate dosing guidelines ..at least they would not apply to 55 million Medicare citizens. ?

Does this mean that the DEA has no legal authority over prescribers treating/maintaining addicts as their professional discretion indicates ?

Does the DOJ have the legal authority to continue to treat opiate addiction as a crime when Surgeon General states it is a mental health disease ?

Did the FDA have the authority to force the pharma that made Opana ER to take it off the market  because it was the drug of choice of some addicts ?

Does CMS have the authority to dictate dosing guidelines for those on Medicare ?

Who can answer these questions?… Who is suppose to enforce this Federal law/statue ?

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Four-Fold Jump In Deaths In Opioid-Driven Hospitalizations

https://www.news-line.com/PH_news28800_enews

People who end up in the hospital due to an opioid-related condition are four times more likely to die now than they were in 2000, according to research led by Harvard Medical School and published in the issue of Health Affairs.

The study results, which stem from analysis of opioid-driven hospitalizations in the United States between 1993 and 2014, provide the first comprehensive look of the trend over time among both privately and publicly insured patients hospitalized for opioid-related conditions.

“More than 35,000 people died from heroin and synthetic opioid overdoses last year,”

said study senior author Zirui Song, an assistant professor of health care policy at Harvard Medical School. “In order to avert preventable deaths, we need better, richer data about the multiple dimensions of the epidemic, including clinical and sociodemographic.”

“These results are just scratching the surface of what health professionals and policymakers could use to help patients and the public, and the picture they paint is concerning,” Song said. “As the United States combats the opioid epidemic, efforts to help hospitals respond to the increasing severity of opioid intoxication are acutely needed, especially in vulnerable and disabled populations.”

LET’S DO THE MATH

People who want to “end the opiate crisis” are throwing around the stat of 60,000 people who die from DRUG OVERDOSES Some will include the fact that abt 40% of those deaths do not involve controlled substances.. Leaving 36,000 dying from some legal/illegal opiates..

According to this study …

More than 35,000 people died from heroin and synthetic opioid overdoses last year

Buried within that above fact is that all Heroin and Synthetic opiods (Fentanyl analogs) are ILLEGAL… being imported from China and Mexico

Do these two FACTS suggests that abt 1000 people died from a OD of a LEGAL OPIATE ? We know that legal opiate prescriptions are decreasing and that suicides by chronic pain pts are increasing… so what is the conclusion ?

We know that 2600 Americans die from some cause EVERYDAY.. using the above 1000 death figure would suggest that 0.1% of those deaths can be related to a prescription opiate – not necessarily legally obtained…  and we do not know how many of those OD’s were intentional (suicide) or accidental ??

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A number of health/disease issues have a correlation to Body Mass Index (BMI)  https://www.nhlbi.nih.gov/health/educational/lose_wt/BMI/bmicalc.htm

The common perception is that those who have a higher than normal BMI… are there because the eat too much or exercise too little.

Some of the diseases associated with elevated BMI are:

Hypertension (High Blood Pressure)

Diabetes

Cardiovascular disease

Elevated cholesterol

All of these diseases have physical measurable values when it can be determined that a person is at risk and is usually determined as being PRE-DISEASE status.

What if our health care/insurance system started to limit treatment for anyone whose BMI is outside of the normal range ?

A pt would be mandated to lose a average of 1-2 lbs/wk until the pt gets their BMI gets into the normal range.

Example: a pt BMI indicates that they are 50 lbs OVER WEIGHT and the pt is provided medication – and paid for by insurance – for the various disease issues they have for ONE YEAR… if they do not reach the 50 lbs loss and get their BMI into the normal range… medication would no longer be paid for by insurance and required hospitalization to treat any health issues related to above recommended BMI would not be paid for by insurance.

If the pt reaches the recommended BMI and still have certain health issues .. then they would be required to participate into mandatory “health club” exercise programs to try and get the health issues to within normal ranges

If the pt is compliant with the mandatory exercise programs and still have some elevated lab values.. then the pt will be required to eat a “proper diet” to get elevated lab values within range.

Only after the pt does/participates all the necessary/mandatory and labs values are outside of normal ranges will the health insurance pay for some medications of the insurance company’s choosing.

If after obtaining all mandatory weight, exercise, diet and stops being compliant and lab values or BMI are out of acceptable range. The pt will be provided a “grace period” to get back to being compliant and if the pt fails to be compliant … coverage for the particular health issues will cease.. and the pt will be required to continue to pay for health insurance premiums so that they have health insurance coverage that are not caused by poor life style factors.

How slippery will this slope get ?

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In October my doctor at the cancer hospital called CVS Caremark PBM for a prior authorization and was told until I am denied coverage for the rx one can not be requested. On 12/5  I was informed by my local pharmacy that I was formally denied coverage for my doctor’s rx by CVS Caremark PBM . I asked for the price difference and the pharmacist totally flipped out on me. I was told with venom based negative affect that he would not dispense any rx for me that was not consistent  with the CVS Caremark PBM rx for me. I told him that CVS Caremark PBM is not my doctor has never even seen me and that their rx for me was an unauthorized reduction in my rx. He became even more angry reiterated that he will not dispense any rx that differs from what CVS Caremark would cover and that what I was trying to do was have him fill two different rx and he was not filling two different rx like that for me that he would only dispense the CVS Caremark PBM rx or  I would need to find another pharmacy and hung up on me.

Steve, I don’t think I have ever been treated like such garbage in my life and for sure the entire pharmacy staff and customer base in that small apothcary heard it the entire tirade. Big issue too is that I no longer even have physical access to my rx bc it is e-scripted to the pharmacy.  I also had a very bad reaction to fillers in varied pharmco brands of my liquid medication so can only tolerate vistapharm liquid bc I become deathly ill from  Edetate Disodium. So my rx even reads vistaapharm brand only which is a special order.

I am being denied legitimate access to pharmaceutical care and benefits for valid medical needs and I doubt anyone cares or will help even if it is illegal. The ADA is no help. I am not on medicaid and although I sent an email complaint to CT Commission of Pharmacy Drug Control regarding CVS Caremark PBM over reach,patient profiling,practicing medicine without a license and making unauthorized reductions to my medication resulting in a denial of access to needed care I do not hold high hopes of any regulatory response. It is now acceptable to treat anyone on pain medication like a third class citizen with no rights in this country. This situation has become very out of control and very abusive. The cancer hospital will again try to obtain an authorization however this entire situation is egregious and they said unless patients are receiving direct chemo or radiation they are frequently being denied access to prescription pain medication on a daily basis now since CVS Caremark PBM has been allowed to operate this way with immunity. According to them none of the regulatory oversight is commenting or wanting to be involved.  I am very concerned that significant medical issues and pain management related issues that are now somewhat controlled allowing me some semblance of quality of life are at grave risk to resurface and do not think that I should become a victim to a “Customer Care” Team that is unlicensed to practice medicine, patient profiling and allowed to remain anonymous. Its all pretty awful…

Just imagine if this is how CVS Health is functioning as JUST a Pharmacy/PBM… just imagine what is to come if the FEDS approve them to buy Aetna and they also become the HEALTH INSURER..

Is it just me… or has CVS quietly dropped their tag line “Where HEALTH is EVERYTHING”… maybe they need to start using the tag line “It is OUR WAY or the HIGHWAY “

One thing that any pt having a C-II prescribed is to INSIST on getting a paper prescription.. because if the pharmacy receiving the electronic order can’t/won’t fill it .. it becomes DOA.

The DEA now allows the receiving pharmacy to transfer the C-II to a different pharmacy… states have to change their state laws to conform to what the DEA allows and all the pharmacy’s Rx dept software has to be modified to conform… the last time that such a DEA change was made – allowing C-II to be electronically submitted… it took YEARS for states and software companies to “get in line” and it became legal to do.

The same is in limbo right now with DEA allowing pts to get less that the full quantity prescribed and are now entitled – by the DEA – to get “refills” up to the total quantity originally prescribed…  but until the states and software companies get their act together… many pharmacies will not be able to do it.

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SOS here in WA state. A WA state pain clinic closure is coming soon – need to get all WA peeps into new WA group. DOH has told ALL other pain clinics NOT to accept these patients and send them ALL to rehab

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I-Team: Nevada doctors will have to comply with new opioid regulations on Jan. 1

http://www.lasvegasnow.com/news/i-team-nevada-doctors-will-have-to-comply-with-new-opioid-regulations-on-jan-1/876634765

LAS VEGAS – As of New Year’s day, Nevada doctors who prescribe opioid medication will have to comply with new regulations. On Tuesday night, physicians received a crash course on how the rules will work.

The new law, Assembly Bill 474, was initiated because of concerns about an opioid epidemic. As 8 News NOW has been reporting over the last several weeks, there is another side to the opioid issue, so what happens to legitimate pain patients?

The news release which announced the event declared that Nevada has the fourth highest overdose mortality rate in the country that is, the state did back in 2010. However, a lot has changed in the last seven years.

Opioid prescriptions in Nevada have dropped every year since 2011 while overdoses and hospitalizations have gone up, so how can that make sense?

At city hall Tuesday night, the medical society helped prepare local physicians for the impact of Assembly Bill 474. The law is not as draconian as some opioid crackdowns enacted elsewhere, but it means any doctor prescribing opioid medication must provide a detailed medical history so that pharmacists can decide if the prescription should be filled.

State officials say Nevadans are dying from prescription opioids, even though about 90 percent of overdose deaths involve illicit drugs including heroin, meth, fentanyl, alcohol and other substances. Chronic pain patients in Nevada already sign contracts which require urine screening and other conditions.

Patients were not part of the panel Tuesday night but were in the audience because they worry the new requirements will turn a bad situation worse.

“It’s very burdensome for prescribing physicians, and I’m really afraid what’s going to happen is that a lot of doctors are just going to quit prescribing these opioid pain medications altogether because they don’t want to be bothered with it,” said Rick Martin, chronic pain patient. “They don’t have enough time to deal with patients as it is, and there are not enough pain management doctors in town or elsewhere to handle the patients thrown under the bus by primary care physicians who don’t want to treat them anymore.”

Martin, a retired pharmacist, says millions of legitimate pain patients are being punished because of the actions of addicts who overdose, mostly on illicit drugs. Under Nevada law, pharmacists can already decline to fill prescriptions, though they are supposed to consult with the doctor first.

As reported in our recent series, the other side of opioids, Nevada pharmacists already use patient profiling to decide if they will fill opioid prescriptions. They also have an unofficial blacklist containing the names of doctors.

   This report stated that they had previously reported that Nevada Pharmacists are “profiling” pts as to who is “worthy”, in their opinion, to have a controlled substance filled. Has the Nevada legislature put responsibilities on Pharmacists that exceeds both their training and legal authority under the state’s Pharmacy Practice Act ?

Since we are dealing with subjective diseases… will pharmacists be held to a higher liability when they fail to “get it right” and refuse to fill prescription(s) written by a legal prescriber ?

There was a couple of physicians in the early 90’s that got sued for refusing to treat the pain of end of life cancer pts. The survivors in the families sued … not for malpractice… but for pt/senior ABUSE.. and each lawsuit the plaintiffs were awarded ONE MILLION + for pt/senior abuse..

Normally filling a C-II prescription takes the pharmacist 2-3 times everything else because of administrative tasks that only the pharmacist can do. Asking a Pharmacist to take on the added time consuming task of “evaluating the pt’s needs” for the controlled substance could cause a lot of pharmacists to “just say no” or more commonly stated phrase “I’m not comfortable”…

But this state mandate on pharmacist could come back to haunt their employer by not providing enough staffing hours for the pharmacist to do this mandatory task(s) and/or the pt’s PBM/insurance by not providing proper funding that allows the employer to provide proper staffing.

Since we are talking about a state mandate and potential profiling, and if the board of pharmacy (BOP) can find their “balls and backbone” they should be able to act on consumer complaints of unprofessional conduct  against both the permit holder (employer) and the PIC ( Pharmacist in Charge) and the dispensing pharmacist – if not the PIC.

The primary charge of the BOP is to protect the public’s health and safety… if they fail to act on obvious and gross harm to a specific segment of the population, could those individual members of the BOP be sued for failing to “do their job” ?

Since those pts who are suffering from subjective disease… – in theory – they should be covered by the Americans with Disability Act and Civil Rights Act and if it can be proven that all involved (PBM/insurance, employers, pharmacists) put policies and procedures in place that cause profiling to happen and legit/on time/medically necessary medication was denied … which could be considered a civil rights violation of all those pts covered under those two laws.

There are so many moving parts to this whole issue…This could keep a lot of personal injury and civil rights attorneys very busy for a long time.

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There are hundreds – thousands of “supplements” that make “suggestions” as to their ability to help a pt’s health and they all have the statement including on the label as to the fact that they are not approved by the FDA

Dietary Supplement Products & Ingredients

https://www.fda.gov/Food/DietarySupplements/ProductsIngredients/default.htm

The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.

Unlike drugs, supplements are not intended to treat, diagnose, prevent, or cure diseases. That means supplements should not make claims, such as “reduces pain” or “treats heart disease.” Claims like these can only legitimately be made for drugs, not dietary supplements.

Dietary supplements include such ingredients as vitamins, minerals, herbs, amino acids, and enzymes. Dietary supplements are marketed in forms such as tablets, capsules, softgels, gelcaps, powders, and liquids.

Under existing law, including the Dietary Supplement Health and Education Act passed by Congress in 1994, the FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated (e.g., that the product is unsafe) or misbranded (e.g., that the labeling is false or misleading).

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Steve,

I recently started having trouble with the Wal-Mart Pharmacy .  My doctor prescribes a topical cream for dry skin (Clobetasol).  The pharmacy has been giving me this medication without incident for at least two years.  The last two times I attempted to refill my prescription the Wal-Mart employee behind the counter refused to refill my prescription until I provided several pieces of medical information: 1) Application area; 2) Amount being applied; 3) Size of the tube needed.  As aforementioned, it was a refill so they had that information.  As far as the other information is concerned, I refused to answer it and they refused to refill the prescription.  I walked out, called my doctor, and Wal-Mart Pharmacy left a message my prescription was ready.

I called Wal-Mart customer service and explained to them, in no uncertain terms, would I ever give my protected medical information to anybody at Wal-Mart outside of allergies and current medications I am taking.  They insisted they have a legal right to demand this information and will continue to refuse to refill my prescriptions unless I provide it.  They also intimated that insurance companies are insisting on my medical information due to a new policy that has taken effect in the last 6 months.  

I have taken your advice and contacted the Board of Pharmacy.  Before I submit my complaint, could you provide me with any references to the specific HIPAA law that protects the privacy of my medical information and which law that mandates a pharmacist can not refuse to fill a valid on-time prescription.

Thank you,

This is a educated guess… but.. it sounds like to me that your insurance and/or PBM (Prescription Benefit Manager) is demanding this. What I suspected that your PBM showed up at Wal-Mart one day to do a audit… and what I have heard that these PBM auditors show up expecting new data points that have never been looked for in previous audits.

These audits seem to get more and more draconian with each succeeding year…  They start out with supposedly selecting a “random” 1% of a pharmacy’s claim and then like with prescriptions like yours.. rejects the claims because certain “new data points” are not on the prescription… and there is no “making up the missing data points”… and then they reject the claim… and look at all the refills on that single prescription… take the $$ value of the Rx – including refills – and then when they are done with the audit they take the rejected claims and multiple the “amount due” by ONE HUNDRED .. because there was a 1% sampling… so the mistakes on that sampling must reflect all the mistakes that the pharmacy made on all the prescriptions billed to that PBM.  With three PBM’s controlling the vast majority of prescription claims.. and the PBM’s paid for some 80%-90% of all prescriptions… I have heard of some pharmacies get “audit recoup demands” of 10,000’s of dollars and the pharmacies are prohibited by their contract with the PBM to attempt to recoup any money from the pt for the rejected claim(s). With the average Rx price approaching $60 each.. it doesn’t take many clerical errors for a recoup demand to get to those $$$ figures.

And the contracts with the pharmacies are presented on a “take it or leave it” basis.. if you don’t take/sign the contract the PBM will make sure that your Rx patients will be sent to one of your competitors that has signed the contract.

5-6 years ago, Walgreens tried to negotiate with the PBM Medco – now part of Express Scripts – and refused to sign the contract offered.. because they felt that the reimbursement offered was TOO LOW & unprofitable…  Walgreen’s caved after about one year.. because they lost too much business.

And I would bet that Wal-Mart is prohibited by their contract with the PBM to charge you cash and let you file a claim with your insurance company.

The PBM industry is sort of like what we have heard about the Mafia and extorting money from retailers to allow them to stay in business… and it is all perfectly LEGAL… because the insurance industry is exempt from Sherman Antitrust Act by the McCarren Ferguson Act…  they can do things that are ILLEGAL in the rest of the business world …without consequences …

IMO, you can file complaints but your PBM is standing between you and you getting your prescriptions… with the demands for particular personal data points.

I just got a email from a pt on some eye drops and the PBM told the pt that he would have to get by with 4 bottles a month and I calculated that he would need – according to the directions – at least 7 bottles/month and that worked under the presumption that he “hit his eye” 100% of the time with each drop… which – IMO – will not happen in the real world …the pt’s doctor wrote for 10 bottles/month… which to me sounded like a reasonable number.  IMO.. the PBM was just “playing games”… hoping the pt would just accept their mandate… PBM’s and insurance companies are FOR PROFIT business and when it comes to a pt’s quality of life and their bottom line profit.. guess which one get their priority ?

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