Judge Richard Leon and CVS on Aetna acquisition

http://pharmacistactivist.com/2019/AUGUST_2019.shtml

EDITORIAL:
Judge Richard Leon and CVS
The Department of Justice approved the acquisition of Aetna by CVS-Caremark and many view this as “a done deal,” and the companies have portrayed it as such. However, this action requires the review and action of District Court Judge Richard Leon. To his credit, Judge Leon astutely recognized that there were implications and important concerns with respect to this proposed acquisition that warranted further investigation and evaluation (please see my letters of December 5, 2018 and January 24, 2019 to Judge Leon in the February issue of The Pharmacist Activist).

In addition to Judge Leon’s own thorough study of this situation, he held two days of hearings in June, at which the involved companies, and organizations that were opposing the acquisition, presented testimony and responded to questions. Following the hearing the Department of Justice asked to call more witnesses. The Judge denied the request, saying it was “phantasmagorical.” I had to consult my dictionary and, for the benefit of the one or two readers who also do not know the meaning of this word, it is defined as “a rapid, bewildering sequence of fantastic images, as seen in fever or dreams.” That characterization had previously escaped my awareness, but it can also be applied to CVS.

Judge Leon conducted a final hearing on this matter on July 19 following which he noted that he would announce his ruling in the not-distant future. I very much hope that his ruling blocks the acquisition. However, whatever the outcome, I highly commend him for recognizing and investigating the concerns, problems, and risks that are so well known to pharmacists.

In anticipation of the hearing scheduled for July 19, I wrote to Judge Leon on July 8 and this letter is provided below. In addition to the responses I received from pharmacists and that were included in the May and June issues of The Pharmacist Activist, I provided to him some additional responses I received. These responses, as well as responses I have received after I wrote to the Judge on July 8, are provided in this issue following my letter.

July 8, 2019
The Honorable Richard J. Leon
U.S. District Court for the District of Columbia
333 Constitution Avenue N.W.
Washington, D.C. 20001

Dear Judge Leon:

I commend your continuing investigation of the potential consequences of the proposed CVS-Aetna acquisition/merger. I have previously communicated my strong concerns, with supporting information, about this proposed merger in my letters to you of December 5, 2018 and January 24, 2019. I have included copies of these letters.

During the last several months, I have been made aware of even more ways in which CVS-Caremark manipulates, disrupts, and fragments the pharmacy marketplace for its own benefit and profits, and at increasing risk of errors and harm for consumers. I have included many of the communications I have received in the May and June, 2019 issues of my newsletter, The Pharmacist Activist, copies of which I have included. The title of the editorial of the May issue is a quote of a current CVS pharmacist, “I believe I am a danger to the public working at CVS.” The editorial in the June issue includes communications from current and former CVS pharmacists and is titled, “They Must be Anonymous, But They Will Not be Silent.”

I continue to receive numerous communications from pharmacists, some of which will be included in the August issue of my newsletter. I have included a preliminary draft of much of the content of this issue. In addition to the strong concerns voiced by CVS pharmacists, I would call attention to the commentary on pages 4 and 5 from an employee pharmacist in an independent pharmacy. This commentary identifies what I consider to be anticompetitive and unfair practices and actions of CVS-Caremark, that may also be violations of HIPAA. These concerns do not even address the abysmal compensation that CVS-Caremark provides to other pharmacies for dispensing prescriptions in Caremark-administered prescription plans, and that has been an important factor in the closure of many independent pharmacies.

These situations describe the situation that presently exists. If CVS is permitted to acquire Aetna, the resultant power and domination of these already huge corporations will become even more anticompetitive, and the consequences will be even worse than they are now.

I urge you to take action to prevent the acquisition of Aetna by CVS. I also urge you to initiate action that will require CVS to divest Caremark.

Thank you for the concern you have already demonstrated and for your consideration of this additional information.

Sincerely,
Daniel A. Hussar, Ph.D.
Dean Emeritus and Remington Professor Emeritus
Philadelphia College of Pharmacy
University of the Sciences
danandsue3@verizon.net

Pharmacist comments
From current CVS pharmacists

“Mistakes are occurring. People are dying!”

(excerpts from a letter to a Board of Pharmacy): “I am writing to beg you to act in the interests of the patients of CVS, Walgreens, and other chain drug stores in _______. I am employed by CVS, so this letter will consist mainly of my concerns with CVS practices, but I am told that other chains, specifically Walgreens, have similar policies and practices.

I believe that the pursuit of profits within CVS pharmacy has reached a critical point, where the lives and health of their patients are being put in danger regularly. CVS corporate has kept their pharmacies operating on a skeleton crew for several years now, and while prescription volume and responsibilities have gradually increased over the years, staffing hours have only been cut. The Board’s decision to allow more technicians per pharmacist several years ago, which I’m sure was enacted in the interest of safety, was actually used by CVS to stop ALL pharmacist overlap within this district. This means that no CVS pharmacies within this district, regardless of prescription volume, have more than one pharmacist on duty at any time. What this means is that pharmacists do not eat, have rare bathroom breaks, and are standing continuously for up to 14 hours. While CVS says they ‘allow’ their pharmacists to take breaks, the system they have in place does not allow this to happen. Because of a constant staffing shortage (which is actually enforced by corporate), pharmacists are responsible for all aspects of running the pharmacy. We are responsible not just for verifying prescriptions and counseling patients–in order to keep the pharmacy functioning, we must be cashiers (in the drive-thru and at the pharmacy counter), we must enter prescription information, count prescriptions, take out trash, answer constantly ringing phones, make ENDLESS unnecessary phone calls (which amount to high-pressure sales calls), and complete hours of required training modules. We are fully aware of our legal obligation to provide counseling for each new prescription, and are reminded regularly that we can be terminated or lose our license if we do not provide this counseling, but our employer makes no effort AT ALL to make it possible for us to provide this counseling. It is laughable to believe that CVS pharmacists have the time to counsel on each new prescription when they have endless metrics that they are expected to meet throughout the day, most of which have a 15-minute time limit before they “go red” and are considered late. But who do we complain to? If we go to upper management, we are told that we are underperforming and are made to feel incompetent–unreachable metrics goals are used to make ALL of the CVS pharmacists feel as if their jobs are in jeopardy at all times. If we complain to the board, we are exposing ourselves to legal action against our license and our livelihood. If unsafe practices are exposed at CVS, the response of corporate will be to place more extreme burdens and expectations on their already laden pharmacists, with no additional help for easing these burdens.

I would like to suggest an answer for how the Board of Pharmacy could ensure the safety of CVS (and other retail chains) patients without allowing drug store corporations to transfer that burden directly onto the shoulders of their pharmacists. Cold calls to doctors’ offices by pharmacists should STOP unless specifically requested by a patient. As it is now, if a patient has enrolled one of their Rxs in the Readyfill service, when it is close to being out of refills, THREE electronic requests are sent to the doctor by CVS. If there is no response to these 3 requests, the Rx becomes the responsibility of the pharmacist, it becomes part of our ‘Doctor request queue,’ meaning we must make an actual phone call (which is timed–it must last at least 30 seconds or we don’t get ‘credit’). Either the doctor agrees to supplying more refills (which is considered a ‘successful’ call), or he will fail to respond or deny more refills (an ‘unsuccessful’ call). What this means is that we are overwhelming doctors’ office staff with constant calls, and patients are often kept on medications that are unneeded for extended period of time. I have many patients who see many doctors and take many medications. They frequently do not know the names of their medications or what they are taking them for. They often agree to sign up for the Readyfill not understanding what this service means. Many come and pick up bags of unneeded medicine on a monthly basis because CVS harasses their numerous doctors into giving refills, then proceeds to harass the customer into coming and picking up these refills (also the responsibility of the pharmacist). I encourage the Board to interview doctors’ office staff and pharmacy staff and see if they feel that these calls are serving patients in any way. Stopping unrequested doctor calls would be in the best interest of not just pharmacists and doctors, but more importantly, it would be in the best interest of patients.

Secondly, staffing minimums MUST be put in place based on prescription volume, keeping in mind that at CVS and other chains, pharmacists are not just responsible for verifying and counseling, they are also responsible for numerous tasks and responsibilities that would be handled by other staff at a more responsible company. Overlapping pharmacists should be a requirement at some of the busier stores, so the work burden can be eased on the pharmacist, and so they have a reasonable opportunity to take necessary breaks. Pharmacies filling a certain volume should be required to have not just a technician, but also a cashier. At all CVS pharmacies, the technicians are expected to also ring up the customers at the registers, which means that at many of the stores, the lone technician is stuck at the register helping a steady stream of customers when the pharmacist is left to count the Rxs, verify, counsel, answer the constantly-ringing phone, and make the ever present doctor and patient calls. In deciding the staffing minimums, prescription volume should be the primary concern, but also what other duties are expected of the staff. If cashiering, housekeeping, and numerous metrics are part of the job description, then adequate staffing should be provided so that the primary duty, PATIENT CARE, is not neglected.

CVS has recently put into place a much-needed 2-step verification process. Most other chains have had this in place for years. It would work tremendously well for a well-staffed pharmacy. What it means for the CVS pharmacist is that one more metric has been put into place. There is one more queue to watch and another opportunity to ‘go red.’ It is inhumane. I have been at CVS for many years and I am currently looking for another job, as are most of my colleagues. If we leave CVS, there will be an abundance of inexperienced pharmacy school graduates to take our place for less compensation, so CVS will not suffer the consequences of their actions at all. The occasional lawsuit from customers harmed by their practices will be settled quietly out of court for a sum of money that will be less than what it would require to staff their pharmacies adequately to begin with, so they are not being harmed financially by their unsafe practices. I have only retail experience and have found that most of the larger chains have made note of the ‘success’ of CVS and are following suit in their practices. I am discouraged and fearful not just for my career and profession, but most importantly, for the millions of chain pharmacy customers. I am begging the State Board to make a difference in this state. Protect the patients in our state by demanding that their professional pharmacists are treated with the minimum amount of dignity to do their jobs well. Please. Thank you so much for your consideration. From a terrified, exhausted CVS pharmacist.”

“I have practiced pharmacy for many years. I work at CVS currently and can attest to the conditions (that other CVS pharmacists have described that are included in your newsletter). For the first time in my career I actually dread and fear a shift at work. The staff morale is at a burnout level. I hope to assist you in making these issues known and acted upon. I agree completely that public safety is compromised and errors are increasing at an alarming rate.

My Board of Pharmacy recently conducted a survey regarding working conditions. I have inquired about the results but have not received a response.

I would like to add one more fact to the points addressed in the letters to the state boards (included in the May issue of The Pharmacist Activist). The fact is there is no possible way that a pharmacist in these conditions can meet the legal requirement of mandatory counseling on new prescriptions. I feel that this may be the position we must take to force action. The fact is CVS is in violation of law. CVS will not staff pharmacies adequately to meet this legal requirement. CVS is aware of this violation and continues to cut staff.

I challenge CVS to prove that mathematically a pharmacist can fill over 300 Rxs and counsel on 200 new ones in a 12 hour shift with one technician. This is in addition to ringing up every transaction on the register and answering every phone call. No call center staff and no cashiers. This is the current situation at my CVS location. Every CVS that I am aware of also works a skeleton crew. An industrial engineer could calculate the time required for each task and I guarantee that the results will show we are being put in an impossible situation. I’m good at what I do but I will say this – I cannot deny the laws of time and space!”

(Editor’s note: I responded to this pharmacist and provided some suggestions, and also cautioned about the importance of remaining anonymous. The pharmacist quickly responded with the following additional comments.)

“You are free to use any ideas I share without using my name. I have no doubt that there would be instant retaliation when corporate would identify me as a ‘whistleblower.’ One important point in quantifying staffing levels is script count measurement. This is manipulated falsely by CVS when determining staffing and bonuses. In my opinion, for true representation of work being done, it is crucial to include all prescriptions processed in any calculations used to determine allowable technician hours. This is not the case. One trick that is used by CVS in determining volume of a location is that they only count the sold prescriptions in the weekly tally. The ‘return to stock’ prescriptions are subtracted from the total. I realize that unless the script is sold the store doesn’t get paid but it is still work we did to fill it. This maneuver effectively reduces the volume by approximately 20%. For example, if I print my daily log I see the number for scripts filled that day. Usually 300 or so for a weekday and 150 or so for a weekend day. So one would think I am getting ‘credit’ for filling approximately 1800 per week which is what I am actually doing. When corporate weekly reports come out I am listed as a ‘low volume’ store of under 1500 per week. This is because the data is manipulated by removing the return to stock prescriptions from the total filled. Every store has many ‘return to stocks’ daily. Many factors are in play here. I think e-prescribing of entire med lists and superfluous refill requests for automatic fills are the biggest culprits. The return to stock process is also time consuming in itself. Also, for fair comparison, whether a location has cashiers, self check-outs, or call center assistance should be taken into account. CVS has eliminated the cashier position in my pharmacy and our techs must also ring up every sale.”

“Metrics are the top priority for the district managers. My particular district manager is not a pharmacist. Recently he was at our location for his ‘visit.’ The current focus is immunizations. The gist of the ‘conversation’ (i.e., ‘instructions’) was to test bill insurances for payment of pneumonia vaccine. That, I assume is his way of assessing appropriateness of such. He went on to tell me that he knew (from a drug rep) that infants get several doses during their first year so it must be safeâ€|although he didn’t even know the name of the vaccine. We barely have time to administer vaccines in a safe manner, let alone screen for appropriateness.

We are also being ‘encouraged’ to do off-site flu clinics on our day off. We will be paid; however, this is without tech help. We are to go alone and are responsible for picking up supplies, transporting, returning, paperwork, etc. I question cold supply chain, etc. Of course, the front of the store is on board and has suggestions of where we can travel to. All of this is verbal. . . too smart than to incriminate themselves in writing.

We all fear for our jobs if we have low numbers, etc. I always think that they can’t possibly ask us to do one more thing, but then they add to the workload and take away tech support.

I have to say pharmacy schools shoulder some of the blame for this in that they cranked up enrollment and programs for extra tuition dollars. Supply and demand. . . provided entirely too much supply to make it easy for the chains to take full advantage. You may use any of the information that I provided but please keep me anonymous. I’m trying to hang in there as long as I can.”

From former CVS pharmacists

“I have another position with flexible hours but worked part-time for CVS for more than 20 years. I would travel wherever they needed me, taking emergency calls nobody else would take, filling in double shifts on holidays nobody else would work. I got behind one day because of trying to fix insurance issues, customer questions, doctor calls, and a technician that called in sick. I was reported by the store manager for being too slow. I got a call from the new district manager and was berated and yelled at for being behind. During the next few weeks the relief shifts disappeared. I was told that the hours of some full-time pharmacists had been cut and that they were being given the shifts I had been asked to fill. I had no shifts at all for quite awhile. I vividly remember getting my mail one day and seeing a letter from CVS. The letter read: ‘Dear 0000000 (employee number) – You have been terminated for not working a shift in 90 days.’ After all those years, all I am is a number. No phone call, no thank you, nothing!”

“I worked in a number of CVS stores and saw and heard lots of things that bothered me enough to write things down. I filed numerous ethics complaints and at times I contacted the Board of Pharmacy and DEA. I needed to take a leave of absence because of a very painful medical issue and CVS fired me at the start of the leave of absence. I am pursuing legal action.”

“There are hundreds of cites and fines in our state regarding CVS.”

(Following recollections of earlier mostly positive experiences): “Next came the bean counters that were in charge of pharmacy operations. Why have pharmacists involved? So now all of a sudden we had too many pharmacy personnel and the bottom line was not being met. Five years of pharmacy school to ring the register. Never mind trying to find time to counsel a patient. Our profession has regressed to being questioned, ‘Why can’t you do your job faster and with a minimum number, or less, of staffing you really need?’ After 50 years of seeing things go from fun, to bad, to stupid, I gave up my license.”

From an employee pharmacist in an independent pharmacy

“The same games occur over and over again with CVS-Caremark and PBMs in general. Frankly, I am tired of these games and they wear on me as a community pharmacist. The following are things I experience on a daily basis, most often with CVS-Caremark:

Prescription stealing directly from physician offices—CVS has taken it upon themselves to contact physicians’ offices and take all brand new prescriptions without patients knowing it. I have seen an uptick in patients calling the pharmacy saying CVS is sending automatic messages either from a local CVS or a CVS mail order facility saying their prescription is filled and ready. These patients have been customers of ours and have NEVER filled a single prescription with CVS. They are very confused and want to know why this is happening. Who is contacting the doctor to say it is ok for CVS to take that prescription and all future new prescriptions?

Mandatory use of CVS after 2 fills—this seems to get worse from year to year. Most notably, CVS-Caremark allows the first 2 fills of a prescription at the patient’s pharmacy of choice. Then it becomes mandatory to use CVS-Caremark’s mail-order pharmacy or a local CVS store.

Medication therapy management (MTM)—MTM in theory sounds great as it can help in identifying noncompliance and resolving disease and therapy issues. HOWEVER, I would estimate that 95% of the MTM cases I complete for patients in CVS-Caremark benefit plans involve asking a prescriber to switch patients from a 30-day to 90-day supply of medication. In return, they may pay you a little bit more for completing the MTM case. A 90-day supply sounds great for compliance and cost savings. However, when mandatory use of CVS-Caremark kicks in, wave goodbye to all your patients.

MTM performance scores—CVS-Caremark provides points for disease state management, compliance, and enrolling patients for 90-day supplies (which are eventually lost to CVS). So the slow bleed of losing customers begins. Many patients are also contacted by CVS representatives handling MTM cases calling OUR patients. How does it make sense to conduct MTM on a patient without a profile who does not fill their prescriptions at CVS? Eventually when CVS-Caremark steals the patient, why would they need you to conduct MTM for the patients they stole from your pharmacy? It seems like they control the whole MTM process anyway, and their games seem like HIPAA violations.”

From a Walgreens pharmacist “Several years ago Walgreens tried to take a stand against Express Scripts’ low reimbursement. For a year, Walgreens did not have a contract. Walgreens developed an entire strategy and hoped that the service might be able to get people to talk to their employers and change away from Express Scripts. This did not work and, unfortunately, all the other pharmacies jumped on the opportunity and advertised that they took Express Scripts. Prescriptions were transferred out left and right. A year or so later, Walgreens got back in the Express Scripts network.

Nowadays, CVS-Caremark and its acquisition of Aetna have hurt tremendously. There are many groups in the CVS-Caremark that Walgreens is not contracted with. Other groups allow members to fill a few months at the retail pharmacy before being forced to switch to either CVS or their mail order. Most of the Aetna plans have significantly cheaper copays for people to go to CVS. All of this greatly hurts the ability to obtain prescriptions elsewhere. I know in my area we saw tremendous losses of prescriptions due to this. Last year Walgreens nationwide saw bonuses cut in half due to not meeting expectations set the previous year. Meanwhile, I have friends at CVS who said they received their largest bonuses ever.

PBMs make it difficult for even a large chain like Walgreens to be profitable. My store has seen massive cuts in help. Our reimbursements are down so, even though in June we had a 3% increase in prescriptions compared to June 2018 (despite further loss of Caremark and Aetna prescriptions), our revenue was actually slightly down. This resulted in a 10% decrease in tech help compared to the same month last year. Increases in prescription count and expectations with a decrease in hours is a recipe for problems in patient safety and increased workloads and stress for the pharmacy staff.”
Solutions for some
“After being fired by both CVS and later Walgreens for practicing pharmacy the way I was taught and the way I believe Pharmacy should be practiced, I bought a compounding pharmacy. Now I have hired enough technicians that I am free to practice pharmacy the way it should be practiced. When I counsel a patient, I have the time I need to speak with them. I interact with my patients all the time and they love it. They like that they can come to my pharmacy and not have to wait more than a minute or two to speak with a pharmacist. Plus, I get to use my education. In compounding, you really get to use your education. Even though we have some sophisticated equipment, I still use a mortar and pestle which I find is the best for making oral suspensions for humans and pets. My advice for unhappy big chain pharmacists is to buy or start your own pharmacy. Join NCPA and take advantage of its Ownership Academy program. Banks will work with you to lend money to buy or start an independent pharmacy.”

“In North Dakota we have an unbelievable pharmacy ownership law that I hope will never go away. However, the health insurance companies and PBM prescription plans are beating pharmacies down. My independent pharmacy had been dispensing 300 prescriptions a day, but I was hating the direction we were going in so I opted out of a major plan due to a 40% drop in reimbursement, as well as some other plans. My volume fell very quickly to 200 prescriptions a day, and along with the backlog of payment from Medicare part D, I almost had a nervous breakdown. I rolled the dice and could not have been happier for what we did as a pharmacy and for our patients, as well as for my sanity. I really wanted to focus on patient care, compounding, and nutrition because those were my passions. Early this year, we drew another line in the sand and walked away from one of the remaining health plans in which we were participating. The financials were looking grim so I developed my ‘pharmacy rescue plan.’ We had to make some cuts but, six months in, we are doing well but are not out of the woods. We have USP 800 and the expense to deal with, but we continue to grow the profitable areas of our practice, compounding and nutrition, which now account for about 75% of our profit. Most importantly, we have time to visit with our patients and we are doing more and more cash consultations because other pharmacies don’t have the time to visit with their patients.”

The responses above that I have received from pharmacists are but a small fraction of the number I have received. However, they reflect the specific areas of risk and concern, as well as the frustration and emotion that exist. I wish I could publically give credit to the individuals who have provided this information but, for reasons that are clear, they must remain anonymous. I highly commend them and express appreciation for the time they have taken to share this information and their concerns for the purpose of increasing awareness of the problems and risks that exist.

Daniel A. Hussar
danandsue3@verizon.net

New York state started levying an excise tax on opioids, pharmacies bear the burden some pharmacists have stopped filling the prescriptions

Community pharmacies struggle to stay open

https://www.recordonline.com/news/20190817/community-pharmacies-struggle-to-stay-open

When Baxter’s Pharmacy in Goshen closed in late June, it left more than an empty storefront.

The closure left customers with a choice: Find another local, family-owned independent drugstore and travel a little farther, or switch to a big nationally owned chain.

“The whole time we’ve lived here, 20-plus years, we’ve used Baxter’s,” said Michele Meek, who works at Linda’s Office Supplies, just a couple of doors down Main Street from the former Baxter’s. “I’m trying to make my choice now: Am I going to go to CVS, or am I going to go to the one in Florida?”

The Florida Pharmacy is a bit out of the way for Meek, who lives in the Village of Goshen, but she likes to shop at small businesses. And when she called CVS with a question, she said, she got an automated system. When she called the Florida Pharmacy, she got a friendly, helpful person.

John Nemeth, who owned Baxter’s, declined to comment for this story.

Baxter’s was the second independent community pharmacy in Orange County to close in the past several months, said Al Squitieri, who owns NeighboRx Pharmacy in Slate Hill. The other was Montgomery Village Pharmacy, he said.

“Pharmacies today are experiencing such low reimbursements, it’s forcing some pharmacies to close,” Squitieri said.

Covering the spread

There are two issues straining independent community pharmacies, both driven by pharmacy benefit managers (PBMs), pharmacy advocates say: the low reimbursement rates, and the tendency of PBMs to try to steer customers toward their affiliated pharmacies.

What’s happening here is happening elsewhere, said Monique Whitney, executive director of Pharmacists United for Truth and Transparency, an advocacy group for independent pharmacists.

“It’s become an epidemic,” she said. “It’s become too difficult as an independent pharmacy to work within the PBM framework.”

PBMs were created to be middlemen among health insurers, drug manufacturers and pharmacies, the idea being that PBMs would make prescription drugs more affordable and accessible to consumers. PBMs manage formularies, process claims, negotiate drug prices with manufacturers and set reimbursement rates for pharmacies.

“Now, they’re dictating the rules of the game,” Squitieri said.

The Pharmaceutical Care Management Association, which advocates for PBMs, says the entities advocate “on behalf of patients and payers to reduce prescription drug costs.” “PBMs are an integral part of solving America’s prescription drug pricing and affordability challenge,” reads a statement by PCMA President and CEO JC Scott on the organization’s website.

PCMA says PBMs encourage competition among drug makers and pharmacies and give customers incentives to “take the most cost-effective, clinically appropriate medications.”

PBMs negotiate price concessions – rebates – with drug makers, to lower the cost for consumers, PCMA says.

Three corporations control more than 80 percent of prescriptions in the U.S.: CVS Caremark, Express Scripts and OptumRx. Together, they manage prescription benefits for 266 million Americans. Each of the three owns and operates its own mail-order pharmacy service, a “vertically integrated” structure that gives the PBMs even more control over the drugs dispensed under the plans they administer.

PBMs profit by what’s known as spread pricing. The PBM has a contract setting a discount to the manufacturer’s average wholesale price of a drug for the buyer, or plan sponsor; and another contract setting the maximum allowable cost, plus a small dispensing fee, for the pharmacy. Any positive margin ends up in the PBM’s coffers.

“They operate in an arena that’s not transparent,” said Steve Moore, president of the Pharmacists Society of the State of New York and a pharmacy owner from Plattsburgh.

“Take a self-insured employer, like a municipality,” he said. “A PBM will say ‘You’ll save money if you use our mail-order pharmacy.’ They never tell the municipality ‘You’ll pay $100, but we’ll pay the pharmacy $30 of that.’ They’ll tell the city ‘it costs $100, but we’ll charge you $80.’”

In Ohio, spurred by a series of investigative reports by the Columbus Dispatch newspaper, the state Auditor found that PBMs may have overcharged that state’s Medicaid program by $224.8 million in spread fees from April 2017 through March 2018.

On Jan. 17, the PSSNY released an analysis estimating that PBM spreads led to at least $300 million in overcharges to New York Medicaid managed care programs from Jan. 1, 2016 through March 31, 2018. For perspective, New York’s Medicaid managed care programs paid nearly $1.3 billion total for generics in 2017.

A report published May 31 by the New York State Senate’s Committee on Investigations and Government Operations, led by committee Chairman Sen. James Skoufis (D-Woodbury) and Health Committee Chairman Sen. Gustavo Rivera, made similar findings to the PSSNY analysis and called for legislation to remedy the issues.

In response, the New York Legislature passed a bill that would, among other things, subject PBMs to licensing and regulation by the state Health and Financial Services departments, prohibit conflicts of interest and anti-competitive practices by PBMs, mandate that PBMs operate primarily in the best interests of the insured person, health plan or provider, and that they disclose terms of contracts, including pharmacy dispensing fees and to account to payers for rebates, fees, chargebacks and pharmacy reimbursements.

The law is awaiting Gov. Andrew Cuomo’s signature.

“We’ve been calling for this reform for years,” Moore said. “We’ve been calling for an end to spread pricing for 20 years.”

The federal Affordable Care Act tried to rein in PBMs and insurance companies by mandating the Medical Loss Ratio, requiring insurers to spend 80 percent of their money on care and keep just 20 percent to pay administrative costs and expenses.

“All that did was give them incentives to raise their prices,” Moore said.

Opioid tax backfire

As of July 1, New York state started levying an excise tax on opioids, imposed at the first sale in the state, with the first tax payments due on Jan. 1.

Some drug manufacturers and distributors decided they wouldn’t sell in New York, Moore said, creating shortages that could eventually drive up the drug prices. Some decided to absorb the tax, and others passed it along to pharmacies. The result, in many cases, is that it costs the pharmacists money to fill the prescriptions.

“I don’t think it was the intent of the law for pharmacies to bear the burden,” Moore said.

As a result, pharmacist Joe Giangiacomo said, some pharmacists have stopped filling the prescriptions.

“It’s created such a chaotic environment for so many patients,” said Giangiacomo, who owns Rock Hill Pharmacy. “They legitimately need these for pain management, and they’re being turned into seekers.”

Squitieri said he’s been talking to Skoufis and Assemblyman Colin Schmitt about their work on this and other pharmacy-related issues.

The local touch

Giangiacomo bought Rock Hill Pharmacy about three months ago. He graduated from pharmacy school in 2002, and worked retail pharmacy at chain stores for a while.

He said he saw a more hands-on approach as the future of pharmacy: things such as administering immunizations and checking blood pressure, and so he went back to school and earned his doctorate.

“It makes it so much harder when you have all these other things pulling away from what pharmacy is supposed to be,” he said.

According to the National Community Pharmacists Association, a trade group representing independent pharmacists, it’s not just independent shops being closed. From 2011-2016, a total of 3,622 pharmacies closed across the U.S., with independents making up 42 percent of those. Walgreens closed 70 of the Rite Aid stores after its acquisition, including the Fulton Street store in Middletown. Kmart store closures also shuttered their pharmacies; and several regional chains sold to CVS, which shut down stores.

Bob Newhard Jr. is a second-generation pharmacist at Akin’s Pharmacy in Warwick. His father bought the store in 1962, and Newhard and his sister bought the pharmacy from him in 1988. The business is getting harder and harder, he said.

“The pharmacists take the brunt of everything,” he said. “We have to deal with the customers, insurance, the wholesalers, et cetera.”

Sometimes that happens even with the PBMs’ customers, Squitieri said, pointing to a recent major recall of a blood-pressure medication.

“The answer the mail-order pharmacies had,” he said, “was ‘go to your local pharmacy.’”

“If push comes to shove,” Squitieri said, “if they take us out of the community, there’s going to be a big loss.”

Mail-order services can fall behind changes in dosage or medication, and they don’t provide the counseling local pharmacists can, Squitieri said.

“They don’t give the personal touches an independent pharmacist can give,” he said. “We do it because we get to know people.”

What happens when a pt’s treatment for a terminal disease interferes with a insurance company’s need for profits ?

Cancer patients are being denied drugs, even with doctor prescriptions and good insurance

https://www.fresnobee.com/news/local/article232478212.html

Norma Smith was diagnosed with stage-three cancer in December.

In Smith’s case, that’s the last stage of her blood cancer, multiple myeloma, which had spread extensively.

As it attacked cells in Smith’s bone marrow, an important part of the immune system, the 62-year-old was eager to start treatments to stop it. What happened instead in the months that followed was Smith’s pharmacy denying and delaying chemotherapy treatments prescribed by Smith’s medical doctor over and over again.

Smith, a retired special education teacher in Fresno, and her husband, Rodney, a retired school psychologist and director of special education, consider their “very expensive” health insurance coverage to be “the best.”

But that insurance didn’t ensure Smith would get the drugs she needed when facing CVS Specialty Pharmacy – the pharmacy their insurance required them to use. Cancer drugs prescribed by Smith’s oncologist were denied because they didn’t follow the standard protocol sequence of medications that Smith’s pharmacy benefit manager, CVS Caremark, had in their guidelines.

That means pharmacy benefit managers have the authority to trump a doctor’s medical judgment without seeing patients or knowing their full medical history, and without accountability for the consequences of what happens to sick people.

Smith is among thousands of documented cases of patients who have been denied needed medications in this way. Doctors and other medical professionals say these denials are only expected to get worse as the country’s largest health insurance companies and pharmacies are increasingly joining forces.

These elusive middlemen with the authority to deny doctors’ prescriptions based on company policies are sometimes referred to as PBMs for short. Doctors and patients believe they are causing life-threatening problems for people like Smith.

The role PBMs play in health care is being examined in some proposed legislation related to costly pharmaceutical drugs and patients’ access to medications.

“Every time we want to make a change (to medications), we have to go through this whole process where someone – and we don’t know who it is – someone has the right and authority to override my judgment and what the patient needs,” said Smith’s oncologist, Dr. Ravi Rao, of cCare Cancer Center in Fresno, “and that person is functioning without us having a recourse to it. He can do whatever he wants, he or she, and I can’t call them and say, ‘Hey, by the way, what you’re saying doesn’t make sense,’ because they are hiding behind all these processes, and we are struggling here.”

Trouble getting cancer drugs, chemotherapy

CVS Caremark denied cancer medications prescribed by Rao for Smith several times over the past seven months. Each denial resulted in challenging delays. In the worst instance, Smith waited nearly two months for a cancer drug her doctor ordered.

Rao said Smith’s health had deteriorated so much by the spring that she could have easily died. At one point she was nearly bedridden, using a walker to get to and from the bathroom.

“This whole process has been extremely painful,” Rao said, “extremely traumatic for the patient and her family.”

Smith’s story is “an example of how bad things can get” for cancer patients who require different medications than what pharmacy benefit managers consider standard protocol.

“You are making us practice medicine based on some policy or guideline written by someone else,” Rao said. “So if you are a patient who has something slightly unusual – and Norma is very unusual in her disease – if I say, ‘Hmm, you know what, this disease is strange. We cannot follow the textbook guidelines that are laid down by any agency,’ I’m out of luck.”

It wasn’t always so hard to get medications. Rao said for many years, insurance companies would often ask for prior authorizations, but the process was somewhat streamlined. “There were delays by a little bit, but not by a whole lot.”

Those delays increased significantly because of pharmacy benefit managers, hired in response to rising drug prices, Rao said. They act as “one more layer of bureaucracy to go through before we can give the patient the drug.”

Those cancer drugs for Smith include chemotherapy infusions and injections she receives at cCare, along with pills she receives in the mail. A pharmacy benefit manager is involved with authorizing all of that.

“Now if this was an isolated incident by a company that was unusual, that would be one thing, but this happens to be a very common problem that we’re facing,” Rao said. “Especially over the last three to four years this whole PBM issue has become a huge issue, and when I talked about this to my colleagues, everyone has similar horror stories. And when I speak to my colleagues in other states, it appears that this is a problem all over the country.”

PBMs can work for a number of different entities. In Smith’s case, she’s dealing with CVS Caremark, the prescription benefit management subsidiary of CVS Health, which controls what pills she receives from a CVS Specialty Pharmacy and the drugs she receives via infusions and injections at cCare.

And her insurance – a plan through Anthem Blue Cross that costs around $500 a month – requires she use CVS.

But customers can’t actually visit a CVS Specialty Pharmacy, according to CVS. Cancer pills are either mailed to a patient’s home or shipped to a regular CVS store for pickup.

“My husband would call and be on the phone for five and six hours trying to advocate for me,” Smith said, “trying to find out how he could work the system so he could get the needed drug for me so that I would live.

“I’m a human being. I’m not a used car. I have feelings. I’m a person. I want to live. I want to spend time with my grandchildren. I want to quilt. I want to do things. I want to live.”

Timeline of denials

The first cancer drug Smith received was a standard, first-tier chemotherapy medication that she was able to get relatively quickly. Unfortunately, she had to stop taking it after a couple weeks in January because she had a life-threatening allergic reaction, including trouble breathing and a severe head-to-toe rash.

Rao recommended she be switched to another cancer drug, which was denied by the PBM. She was without needed medicine for nearly two months while her case was on “review” before receiving new medication.

As she waited, her cancer grew and her liver function deteriorated. She has a rare kind of myeloma that mainly involves her liver. She started losing a lot of weight and getting very sick.

“I wanted to shift her to a related drug that does not have that reaction, and the insurance company flatly refused; the PBM refused,” Rao said. “I spoke to someone at the PBM and they faxed me a protocol, basically saying that, ‘You do drug combination A first, you go to drug combination B, and only then will you get drug C,’ and what I was asking for was drug C. And so I told the family, ‘Well, this is their policy, so let’s go with drug combination B.’ “

By the time Smith received her second chemotherapy drug – in March – her cancer was much worse. That “drug combination B” that her pharmacy required she take next wasn’t effective. During this time, her liver also began to fail, Rao said.

Her cancer counts were much higher than when she was first diagnosed. Myeloma cells make a protein called light chains, Rao explained, and during this time they had increased to about 3,200. A normal number for someone in remission is 20.

Rao asked again for the drug he wanted for Smith. It was approved, but only in combination with another drug he didn’t want.

“The combination that was their protocol wasn’t what I thought was right because of her deteriorating liver and kidney functions,” Rao said. “And again, that led to another few weeks of back and forth, during which time I was giving her just half the treatment I was planning on giving her.”

Rao was eventually able to get the whole treatment he wanted, but Smith had another severe reaction and had to stop taking it. She needed to be switched a third time to another drug combination.

“That combination included a drug they had authorized in January, but because I was using it in a sort of unusual combination – and that was based on clinical reasoning – that reasoning did not fit in with what they thought should be the third-line drug combination, they again said no. Then it took another week or so, and this time the patient’s husband had learned the nuances of the process. He knew who to call, so I’m pretty sure he pushed a lot of buttons there and, finally, it got authorized.”

Rodney Smith said he had to go all the way up to a top appeals board supervisor before the drugs his wife needed were approved.

The PBMs’ protocol “was used to override my clinical judgment each time,” Rao said. “Each time they said no, the patient suffered as a result, and it led to the decline in her status by the time that we got to the right treatment.”

Since Smith has been taking her newest medications, her health is distinctly better.

Smith said it “took practically an act of God” to get the medications her doctor wanted. She credits the persistence and knowledge of her husband and doctor in keeping her from dying earlier this year. She knows many other cancer patients aren’t as fortunate.

Pharmacy benefit managers vs. doctors: Who is accountable?

These pharmacy denials are also incredibly frustrating for doctors trying to save patients’ lives.

“Unless I prove to the insurance company that this patient is not going to respond, then I’m out of luck,” Rao said. “Now unfortunately, the only way that we might get proof is if the patient gets much worse clinically. What if Norma’s liver had failed in the meanwhile? I can never talk to the person who made the policy. I don’t have access to someone to say, ‘Hey, can you please change your policy?’ The system is completely opaque. We have no idea who is making the decision.”

Rao said one of the strangest denials he received was after requesting a standard drug for a patient with stage-four kidney cancer and tumors in his liver.

“So we get a phone call here to my staff saying that the pharmacist – not the doctor, but the pharmacist – to the PBM called and said they are denying the drug.”

The reason given: The patient should have surgery to remove his kidney first.

“I thought it was a joke,” Rao said.

Rao called that pharmacist about the decision.

“In that particular instance, I got really upset,” Rao said. “I said, ‘The patient is too sick for surgery, and the surgeon has said no.’ They said, ‘Please fax me the surgeon’s note saying the patient is not a surgery candidate before we approve it.’

“Now, is that someone who is second-guessing me, or is it someone who is practicing medicine? And who and why is that person practicing medicine without seeing the patient?

“What if I had sent the patient for surgery and the patient had a bad complication and died from it – who is responsible? Me or the surgeon, not that person on the phone, who has zero responsibility. They have all the power but zero responsibility.”

Rao later learned from his colleagues that they had received the same drug denials for their kidney cancer patients.

“That’s because if the PBM pharmacist or who is in charge says no, well guess what? They’ll save money there,” Rao said. “The money comes out from a different pot. So the patient goes and gets surgery done, it comes out from a different part of the insurance. It’s almost like within the insurance company, they have created little fiefdoms, and each fiefdom is fighting with the others to say no to money that will come out of their pot.”

CVS Health response

CVS Health provided an emailed statement about what happened to Smith:

“We are committed to delivering better patient experiences at lower overall costs,” wrote Mike DeAngelis, senior director of corporate communications at CVS Health.

“As part of that, for these types of therapies, payers (i.e. insurance plans, employers, etc.) often opt to employ utilization management strategies, including prior authorization, which can help ensure that patients access the most clinically appropriate and cost effective medication, and that the medication is used in line with a drug’s indication(s) and the clinical guidelines.

“In this case, we worked with the patient’s doctor and insurer to gain necessary approvals for the required prior authorization and we delivered all medications that were prescribed by her doctor.”

Rao agreed that CVS did eventually deliver medications, “at least if the meaning of ‘delivered’ is construed narrowly.”

“CVS did, eventually – but belatedly – get these life-saving drugs to my patient,” Rao said. “It is as if a fireman sat around watching a house burn, and then finally by acting at the last minute, put out the fire and then says, ‘See, I did my job.’ ”

But to get CVS to act, Rao said, it took “tremendous effort” since PBMs’ medical decisions seem “to have taken precedence over the physician’s clinical judgment.”

Rao said the drugs he wanted for Smith “were clearly prescribed completely in accordance with the drugs’ labels and were completely indicated for this patient’s condition, so it was not as if we were using them off-label, which necessitated so much extra effort.

“If my patient had been less motivated, did not have a husband who was able to go above and beyond most people, and if my office had not been as diligent as we were, this patient may have likely died waiting for CVS to come through.”

On its website, CVS Health says it is “pioneering a bold new approach to total health” that includes “a leading pharmacy benefits manager with approximately 94 million plan members.”

That pharmacy benefits manager, CVS Caremark, was described on the website this way: “We work with employers, health insurance companies, the government and other health benefit program sponsors to design and administer prescription coverage plans and keep pharmacy costs low.”

Growing monopolies

Sitting at his wife’s side in a chemotherapy clinic in July, Rodney Smith talked about how “insurance is not the problem here, it’s just getting the medication. I have the insurance.”

His wife’s doctor interjected.

“Actually, insurance is part of the problem,” Rao said.

A number of insurance companies have purchased PBMs that delay the process, Rao said.

“The longer you don’t get the drug, the more money they save,” Rao said. “The other issue that happens is they say, ‘Well, you can only go through our PBM.’”

So it’s “playing a game,” Rao continued, where a patient receives an authorization from insurance and thinks “it is someone else’s fault that they are saying no – but both are owned by the same entity.”

Ted Okon, chief executive officer of Community Oncology Alliance, has become an expert in understanding this complicated system. He’s testified before Congress on cancer issues and is frequently on Capitol Hill discussing cancer care.

Okon’s oncology alliance, a Washington-based, nonprofit advocacy group that lobbies for federal legislation and has its own political action committee, has documented thousands of stories like Smith’s to advocate for patients and medical professionals struggling to get needed medications.

Rao’s oncology office, cCare, is a member of Community Oncology Alliance, an association of community cancer clinics. Okon and Rao share similar concerns about PBMs and the mergers of insurance companies and pharmacies.

“Especially in the last three to four years, this has been a growing problem,” Okon said. “Unfortunately, I think it’s going to get worse and the reason I say that is, number one, we’ve seen massive mergers in the PBM industry to get us where we are today. We have PBMs that account for at least 80% of prescription drugs now.”

Okon listed the country’s three largest health insurance-plus-pharmacy pairs – accounting for “monopolistic control” of approximately 80% of prescription drugs in the U.S.

1. CVS Health owns Aetna.

2. Cigna owns Express Scripts.

3. UnitedHealth Group owns OptumRx.

Insurance companies can require a patient only use certain pharmacies, as happened to Smith.

“Part of the problem now is that the free market is not happening,” Rao said. “Everyone talks about capitalism at work. This is capitalism not at work. The drug companies and insurance companies and the PBMs are tying things up. There is a vertical integration happening.”

Okon said part of the problem is PBMs also receive “sweetheart deals” – rebate arrangements on the drug manufacturer side that can guide drug selection based on profitability rather than what’s most appropriate for a patient.

“For example, a pharmacy benefit manager will draft a list of approved drugs, called a formulary, for an insurance company,” wrote the Los Angeles Times in a story last year about Cigna purchasing Express Scripts. “The pharmacy benefit manager will go to a drug company and offer to include that company’s drug on its list. In return, the drug company might agree to offer a rebate — say, $10 less on a $100 drug. The customer, however, would still pay $100, and doesn’t see any direct benefit from the rebate.”

The way these drugs are made available to patients is often referred to as “step therapy.” One example: Rao’s story about Smith’s pharmacy requiring her to use drug A and B before getting drug C – even though Rao believed Smith needed drug C after drug A.

Step therapy treatment: Being forced to fail

Rao said step therapy policies used in Smith’s care contributed to her severe decline in health earlier this year.

“It’s just a numbers game,” Rodney Smith said. “You kill off enough people and it works out for them, but it’s not very friendly for us. … We’re talking about death here. This isn’t car sales. We need the medication now – and I’m not even dealing with cost. I was lucky enough to pay for a very good insurance, but insurance doesn’t do much good if they don’t give you the medication you need.”

Okon said he believes the federal government didn’t think step therapy would be used in cancer care but it has.

The hiring of pharmacy benefit managers and the implementation of step therapy was sold as helping bring down costs.

“It’s obviously right-minded that the administration wants to bring down drug prices,” Okon said, “but how you do that is another thing. … This is a huge mistake, and it’s also going to backfire, but unfortunately backfire means patients die.”

Okon called step therapy policies in cancer care “nothing short of inhumane.”

“They literally have to fail first at cancer treatments before they get the next treatment, before they get the treatment the physician wants,” Okon said. “It’s really almost criminal in a way.”

He believes it’s “only a matter of time” before a major lawsuit is filed regarding this issue.

Okon’s wife is an oncology nurse. He hears stories about how these issues harm her cancer patients on a daily basis.

Memories of watching his own father-in-law die with cancer, and his brother survive cancer, also motivates Okon in his advocacy work.

“These are real people,” Okon said. “They aren’t statistics.”

Rao said cCare has 10 staff members whose only job is to deal with prior authorizations, denials and PBM issues, “an extremely expensive proposition” for their practice.

He said it feels like there’s an “elephant on his back” as he tries to treat cancer patients.

“You can’t come into the room with the patient and say, ‘OK, this is what you have, this is what you need.’ It’s almost like, ‘This is what I think you need, let’s see what your insurance authorizes and what the PBM does before we get going.’” Rao said. “And patients very often get frustrated with us, saying, ‘Well, I have a cancer. I would like it taken care of yesterday.’ And I’m telling them the best-case scenario is we start something in two weeks, or maybe three weeks.”

Rao said PBM issues come up at least one to two times a day between the 12 oncologists treating patients at cCare in Fresno. That also takes an emotional toll on doctors.

“If I have three PBM issues in a day, I go home so frustrated,” Rao said, “because that sucks up 50% of my energy.”

Rao said disadvantaged patients in the Central Valley who have Medi-CalMedicaid in California – are facing these same problems “two fold.”

“We are facing enormous problems with treating poor patients. … They’d probably be better off if uninsured,” Rao said. “It’s that bad.”

Rao called it a pervasive issue that’s gone “beyond a joke.” Management tactics seem to be to “throw sand in the gears” and refuse every doctor’s request.

“If you have Medi-Cal, pure Medi-Cal, and it’s run by a management medical company, then you can be rest-assured that your care is compromised because of that fact,” Rao said. “That is added onto the PBM issue. So every Medi-Cal has its own favorite PBM and they also are hurting patients through that process.”

Legislation and a call to action

There are a number of pending federal bills that attempt to deal with high drug costs and roadblocks to getting patients’ medications. Okon said there are three major ones pending:

1. The Senate Committee on Finance’s “The Prescription Drug Pricing Reduction Act (PDPRA) of 2019.”

2. “H.R.1035 – Prescription Drug Price Transparency Act,” introduced by Rep. Doug Collins, R-Georgia.

3. “H.R.1034 – Phair Pricing Act of 2019,” also introduced by Collins.

Many of the cancer pills Smith takes would cost around $600 per pill without insurance. She calls that “insane” and a “rack up.”

At a state level, 27 U.S. states had enacted laws related to step therapy as of January, and seven had pending legislation, Okon said.

In California, legislation was passed in 2015 to help providers bypass step therapy requirements: “AB-374 Health care coverage: prescription drugs.”

Still, step therapy issues persist.

“This cannot seem legal to me,” Rao said of pharmacies being able to trump doctors’ orders, “but somehow this has been introduced. And I think unless physicians, patients and the public expresses its anger as to how this should be done, this will continue. This is not acceptable. This is causing harm and you only hear about the people who are able to speak up.”

Okon said a number of things need to happen:

1. Eliminate rebates and deals PBMs can get for using various drugs, and make things transparent: “We have no idea what these sweetheart deals are that these PBMs are getting.”

2. Watch out for monopolies: Okon said the U.S. Department of Justice made a “mistake” in allowing CVS to buy Aetna last year.

3. More education: Helping employers understand how their employees’ families can be hurt by these companies.

4. No step therapy: It was another mistake, Okon said, for President Trump’s administration to allow step therapy cancer care in Medicare Advantage plans. (That happened in May via the U.S. Department of Health and Human Services’ “Medicare Advantage and Part D Drug Pricing Final Rule (CMS-4180-F).”)

And, patients, medical professionals, and community members bringing these issues to the attention of pharmacies, insurance companies, and elected officials.

Rao also is hoping for a law that makes those who deny care responsible for the consequences of their actions.

Fighting to live

Smith shared a letter she received from CVS Caremark in February, informing her that she would not be receiving a cancer drug prescribed by her doctor.

“Standard Pomalyst Policy states: Coverage of Pomalyst for multiple myeloma is provided when the patient has used 2 or more treatment regimens in the past before requesting the use of Pomalyst,” the letter reads. “The information provided by the prescriber does not indicate that this condition is met. Based on the information provided by the prescriber, use of Pomalyst is not covered by the plan.”

The letter states that the decision can be appealed by mail or fax.

“You may ask for a free copy of the actual benefit provision, guideline, protocol or other similar criterion used to make the decision,” the letter continues, “and any other information related to this decision by calling Customer Care toll-free at the number on your benefit ID card.”

The letter goes on to say that CVS can discuss the decision with the patient’s doctor.

“If your prescriber would like to discuss this decision with a clinical reviewer at CVS Caremark, your prescriber can call CVS Caremark, and we will arrange to make someone available to speak with your prescriber.”

Smith wants a more “user-friendly” and “pro-patient” system.

She’s finally found a treatment regime that’s working for her body and killing her cancer: All-day chemotherapy infusions every other week, a weekly chemo shot in the stomach, and cancer pills. But her most recent prescription for 40 pills just ran out.

Smith expects Rao will want to order more during her next doctor’s appointment later this month. She’s worried a CVS pharmacy benefit manager will again object, resulting in another delay.

Her cancer counts have dropped from over 3,200 at their worst to around 400. She wants those numbers to keep dropping to near zero so she can be considered healthy enough for a potentially life-saving bone marrow transplant.

“And for me as a patient who is going through chemotherapy, I’m trying to live,” Smith said. “I’m fighting for my life. This has been a very stressful time for me. It’s kept me awake at night with anxiety, wondering if my drugs are going to be approved. …

“I’ve been going through this cancer journey for seven months now and I’m trying very hard to keep upbeat and to be strong, but I need better support from the pharmaceutical companies to help me as a patient and to help other patients that go through this. “We want to live. We want the best chance to live, but we need the correct medications to do so.”

 

Law for More Opioid Training in Indiana in Effect

Applications available for paid Senate internships

Aug. 16, 2019

Law for More Opioid
Training in Effect

In 2017, drug overdoses increased 18% in Indiana compared to the previous year. Opioid addiction is having a terrible effect on Hoosiers and their families and has become a major issue for a variety of reasons. One of the contributing factors to opioid addiction is the overprescribing of opioids.

For several years, the Indiana General Assembly has been working to address this issue. In 2018, Indiana legislators passed a bill that requires licensed health care practitioners to receive continued opioid prescription and abuse training in order to help fight this deadly epidemic.

Under this law, which took effect July 1, 2019, any health care professional who prescribes controlled substances must have completed two hours of continued opioid prescribing and opioid abuse education during the previous two years.

Everyone has to do their part to fight addiction in Indiana, whether that means properly disposing of medications or helping someone get treatment, and as lawmakers, we are working to do our part by creating laws to help prevent and treat addiction, as well as enable the enforcement of our laws against those who help feed addiction in our state.

For more information on the new law, click here.

Paid Senate
Internships Available

The Indiana Senate Republican Caucus is offering paid spring-semester internships to college students, recent college graduates and graduate students during the 2020 legislative session.

Full-time positions are available in many departments, including legislative, legal, policy, communications, multimedia and information technology. Qualified candidates must be at least a college sophomore.

Benefits include a $750 biweekly stipend, scholarship and academic credit opportunities, professional development, community involvement and networking.

Chosen applicants will work at the Statehouse in downtown Indianapolis beginning with a mandatory orientation in late December and concluding at the end of the legislative session in March.

More information and applications for internships with the Indiana Senate Republican Caucus can be found online at www.IndianaSenateRepublicans.com/intern-program.

The deadline to apply is Oct. 31.

Community Calendar

Jeffersonville Farmers Market
Every Saturday in August from 9 a.m. to noon at the Big Four Station in downtown Jeffersonville

Farm to Table Dinner
Saturday, Aug. 24, from 7 to 10 p.m. on Chestnut Street in downtown Jeffersonville. Cost is $60 per person with only 150 tickets available.
For more information and to buy tickets, click here.

Community Yard Sale
Saturday, Aug. 24, from 8 a.m. to noon at Gateway Park in Clarksville

Rural Broadband
Funding Awarded

Rural broadband funding was recently awarded to grant recipients across the state as a part of the Next Level
Broadband program.

In Senate District 46, the Washington County Telephone Cooperative, Inc. was among projects awarded funding to improve
broadband access.

Expanding broadband services to unserved and underserved rural communities is important for our state’s economic development. I am pleased with this announcement and look forward to advancing broadband access across rural communities in
the near future.

For a complete list of grant recipients, click here.

Indiana State Police Seeks 80th Recruit Academy

The Indiana State Police is now accepting applications for the 80th Recruit Academy.

Individuals interested in beginning a rewarding career as an Indiana State Trooper must apply online by 11:59 p.m. (ET), Sunday, Nov. 3.

Click here for more information and to apply.

Hoosier Homestead Awards

The Hoosier Homestead Award Program honors family farms that have been owned and maintained by the same family for 100 years or more. The program, instituted in 1976, acknowledges the impact these family farms have made to the economic, cultural and social advancements of Indiana.

In Senate District 46, the Buechler farm was named a Hoosier Homestead.

For the full list of recipients,
click here.

Contact My Office
800-382-9467
Senator.Grooms@iga.in.gov

State Senate, Indiana Statehouse

200 W. Washington St., Indianapolis, IN 46204

317-232-9400

1-800-382-9467

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This email was sent to steve@steveariens.com using GovDelivery Communications Cloud on behalf of: State of Indiana · 402 Washington Street  · Indianapolis, IN ·46204 · 800.457.8283

This showed up in my inbox from my Indiana state Senator and fellow Pharmacist…  What a bunch of BS from the bureaucrats in Indiana.  Ron and I were at Butler U at the same time and we each had our own independent pharmacies in adjacent towns in Southern Indiana. I have sent Ron a lengthy explanation of the short comings of these statements and sent it to his PERSONAL EMAIL… it will be interesting if I get a response…

An Elderly Couple Who Died In A Murder-Suicide Said They Could No Longer Afford Health Care

An Elderly Couple Who Died In A Murder-Suicide Said They Could No Longer Afford Health Care

https://www.buzzfeednews.com/article/skbaer/elderly-couple-murder-suicide-health-care-costs

An elderly couple who officials believe died by murder-suicide left notes expressing concerns that they could not afford to pay for their medical expenses.

Whatcom County Sheriff’s Office deputies responded to a home in Ferndale, Washington, on Wednesday morning after a 77-year-old man called 911 and told the dispatcher he was going to kill himself.

The couple were identified as Brian Jones and Patricia Whitney-Jones, 76, by the Whatcom County Medical Examiner. Jones told the dispatcher that he had prepared a note for law enforcement with information and instructions.

“The dispatcher attempted to keep the caller on the line without success,” the sheriff’s office said in a statement. “The man disconnected the call after saying ‘We will be in the front bedroom.'”

When deputies arrived, a crisis negotiator attempted to contact the couple by phone and with a megaphone for about an hour to no avail. Deputies then deployed a robot mounted camera and found Brian Jones lying next to Patricia Whitney-Jones. Both were dead from apparent gunshot wounds.

The sheriff’s office said several notes were left at the home citing Patricia Whitney-Jones’ severe ongoing medical problems, as well as concerns that the couple could not afford to pay for health care.

Information for their next of kin was also left in a note, officials said. Two dogs who were found at the home were turned over to the Humane Society.

The sheriff’s office is investigating the deaths as a likely murder-suicide.

“It is very tragic that one of our senior citizens would find himself in such desperate circumstances where he felt murder and suicide were the only option,” Sheriff Bill Elfo said in a statement. “Help is always available with a call to 9-1-1.”

Spending on health care for the elderly in the US has been increasing for decades. In 2014, seniors accounted for nearly 15% of the population but approximately 34% of all health care expenditures, according to the US Centers for Medicare and Medicaid Services.

Personal health care spending for people ages 65 and older was nearly $20,000 per person in 2014, more than five times higher than spending per child — $3,749 — and nearly three times as much as adults ages 19 to 64.

Out-of-pocket spending for people ages 65 and older was also higher than other age groups at $2,925 per person in 2014 with people ages 85 and older paying $5,925 per person, according to the health care agency.

 

FDA Director: This whole debate about absence of evidence abt opiates – has gone “off the rails”

Roy Green: Chronic pain patient’s secretly recorded phone plea for help

Roy Green: Chronic pain patient’s secretly recorded phone plea for help

Roy Green: Chronic pain patient’s secretly recorded phone plea for help

Beth was born with spinal cancer. She has undergone numerous surgeries and the Ontario woman suffers from horrifically debilitating pain.

Recently Beth, a Canadian who should be benefiting from our highly touted and “free” healthcare, heard her doctor declare that his medical licence is more important than Beth’s right to have her intractable pain put under control.

READ MORE: Quebec government unveils action plan to fight opioid overdoses, addiction

In fact, Beth’s doctor assured her that she has no right to a medical maximum effort to minimize her agony. The doctor intends to reduce Beth’s long-standing and prescribed opioid strength to one which will assuredly fail to drive away Beth’s thoughts of suicide.

Gruesome!

Beth turned to the bully in the piece. The College of Physicians and Surgeons of Ontario. Repeatedly, CPSO has denied that it threatens opioid-prescribing doctors with sanctions, including a loss of medical licence.

CPSO has assured me doctors are under no such pressure. Doctors have assured me they are.

So Beth and her mother placed a call to the college and were connected with a CPSO representative whose responsibility it is to hear out terrified chronic agony patients.

Then Beth’s mother pressed “record.”

READ MORE: Chronic pain patients who take opioids are stigmatized, study shows

Listen to my program podcast from last weekend, and you will hear what took place.  You will hear a desperate Beth pleading with a bored-sounding CPSO representative for understanding, for caring, for respect.

LISTEN: No answers for a patient shut out of treatment:

You will hear Beth explaining to the CPSO rep that suicide is on her mind.

The response? Indifferent acknowledgment that Beth had done everything which might reasonably be expected of someone driven to desperation by intractable agony.

Help? None. What might Beth do additionally to help her cause? The CPSO representative was clearly stumped by the question.

Beth’s being driven to suicide by her pain? Silence. Not even the perfunctory issuing of a phone number to a suicide prevention hotline.

Silence.

This weekend, Beth will rejoin me as she desperately and literally fights for her life.

READ MORE: Opioid deaths continue to drop in B.C., but more than 100 people died in June

Meanwhile, media are issued numbers of opioid overdose statistics. For the most part, these stats likely deal with drug addicts, not chronic pain patients.

Our compassionate Canadian health care system has a suggestion for addicts.

Addicts should be provided with the best available pain control medications. Which is exactly what the compassionate Canadian health care system is denying Beth and millions of intractable pain sufferers.

I’m not indifferent to the plight of drug addicts, but they don’t need my support. The health and political systems brigands are tripping over themselves to provide street addicts with safe injection sites and whatever else they may require.

Beth, though, is expendable. She and all other chronic, intractable agony patients are collateral damage. Listen to her story on my program this Sunday.

Roy Green is the host of the Roy Green Show on the Global News Radio network.

With opioid abuse surging, expert panel recommends drug screening for all U.S. adults

With opioid abuse surging, expert panel recommends drug screening for all U.S. adults

https://www.latimes.com/science/story/2019-08-13/experts-recommend-drug-screening-for-all-adults-opioids

It’s time for doctors to start asking every patient, every time: Have you engaged in any illicit drug use?

That’s the new advice from a panel of public health experts who examined whether a primary care physician’s time is well spent — and whether patients’ interests are served — by routine screening for drug abuse.

A draft report issued Tuesday by the U.S. Preventive Services Task Force recommends that all U.S. adults be screened for illicit drug use as long as their doctors can do so accurately and, when abuse is detected, offer their patients effective treatment or refer them to someone who can.

Questions about drug use should not only cover the possibility that a patient is taking illegal street drugs like cocaine or heroin, the task force said. They should also explore whether a patient might be sneaking pills from a family member’s pain medication or getting a boost from stimulants prescribed for a child with attention-deficit/hyperactivity disorder.

An acknowledgment of drug use should prompt a physician to warn patients about the dangers they are courting, offer medication-assisted therapy for addiction if appropriate, and refer patients to counseling and further treatment.

The task force has long advised doctors to query American adults — and in some cases adolescents — about their drinking and smoking habits. If the new recommendation is adopted, drug abuse would join the list of risky behaviors to be diagnosed and often treated by primary care doctors.

At a time when addiction has become a leading cause of disability in the U.S. and drug poisonings have become the No. 1 cause of injury-related deaths, some say the panel’s advice is long overdue.

“We’ve been doing this for almost a decade in my office,” said Dr. Gary LeRoy , a staff physician at the East Dayton Health Clinic in Dayton, Ohio, and president-elect of the American Academy of Family Physicians .

The draft recommendation leaves no doubt about the extent of drug abuse in America, he said. A nationwide survey conducted in 2017 by the Substance Abuse and Mental Health Services Administration found that 30.5 million people — roughly 11.5% of American adults — said they had used illicit drugs in the past month.

“All of us should be keenly aware that on average, one in 10 of our patients are doing drugs — whether we ask them or not — and we’re not going to cause someone to use illicit drugs because we ask the question,” LeRoy said. “When you create an atmosphere of trust where you have safe conversations, they appreciate that you ask.”

The task force, a group of experts who advise the federal government on disease prevention, did not extend its recommendation to adolescents ages 12 to 17. Panel members said they could not find enough credible scientific evidence to offer guidance for this age group, and they called for more research on teen drug abuse and treatment. (The American Academy of Pediatrics currently recommends screening all adolescent for substance use .)

It’s been more than a decade since the task force last deliberated on the wisdom of population-wide screening for illicit drug use.

In 2008, a year in which 36,450 Americans died of drug overdoses, the panel did not see a compelling case for population-wide screening. This year, the death toll from drug abuse could wind up being more than twice as high as it was in 2008.

In 2017, the most recent year for which definitive statistics are available, drug overdoses claimed 70,237 lives in the United States, according to the Centers for Disease Control and Prevention. As opioid addiction burgeons and more users are exposed to the powerful synthetic opioid fentanyl, overdose deaths are widely expected to climb even higher in 2018 and 2019.

That context “of course matters,” said behavioral medicine specialist Karina Davidson, who co-chaired the task force’s panel on illicit drug-use screening. But she said the recommendation was prompted by other circumstances as well.

Since 2008, for instance, drug-abuse specialists have devised brief screening mechanisms that help identify illicit drug use and those at risk for it, Davidson said. In addition, she added, a growing stack of research studies has shown that treatments for drug-use disorder and addiction — including behavioral interventions and pharmacological therapies — are effective in helping patients quit or cut back.

That evidence of effectiveness is a key change from earlier years, said Dr. Carol Mangione , a UCLA internal medicine specialist who co-chaired the task force committee that drafted the new recommendation.

“We don’t want to screen for something unless we know there’s an effective treatment,” she said. “If you don’t have a treatment that’s effective for people who screen positive, you haven’t really helped.”

Still, effective treatments remain woefully underused, experts say.

The drug regimens that are most useful for combating addiction — a list that includes naltrexone, methadone and buprenorphine — are rarely offered by primary care physicians, who must contend with a gauntlet of paperwork and training to prescribe them. And many addiction specialists, insurers and state legislatures are suspicious of treatments that use prescription opiates to wean people off illicit opioids.

The new recommendation could help change that, Davidson said.

If doctors know they will be expected to ask about and address their patients’ illicit drug use, more of them will probably do the work necessary to prescribe anti-addiction drugs, and more of them will develop relationships with other care providers to whom they can refer patients for treatment, she said.

That process seems to be underway already, Mangione said. At a recent meeting of the Society for General Internal Medicine, she said, a workshop on medication-assisted treatment for addiction was standing-room only.

“We’re very motivated to use these treatments and to pair them up with individual and group therapy,” she said.

LeRoy acknowledged that some doctors are wary of raising the subject. But when they start to ask the question, and to help patients who acknowledge illicit drug use, they quickly see that many of their long-term patients have been struggling, he said.

“They say, ‘Oh, I had no idea I already had these people in my practice,’” LeRoy said. “ ‘When I started asking these questions and providing the service, they came out of the woodwork.’”

Patients, too, could feel less stigma about drug use, and that might make them more likely to acknowledge they might need help, Davidson said. For some patients with problematic drug use, that earlier catch could head off addiction or even death.

“If everyone is asked, we can get to some people who are at a less-severe stage in their drug use, not all the way into addiction,” she said.

The draft recommendation statement is posted on the U.S. Preventive Services Task Force website, along with a review of the research on which the recommendation is based. The public is invited to submit comments until Sept. 9; after those are considered, the advice may be modified and finalized.

Meth surging in Northeast Ohio, law enforcement blames Mexican cartels

Meth surging in Northeast Ohio, law enforcement blames Mexican cartels

https://www.news5cleveland.com/news/local-news/cleveland-metro/meth-surging-in-northeast-ohio-law-enforcement-blames-mexican-cartels

CLEVELAND — Methamphetamine is back with a vengeance in some communities. Although, it never completely disappeared from the streets of Northeast Ohio, it is back in record numbers.

“Those are border type seizures being seized in Northeast Ohio,” said Keith Martin, Assistant Special Agent in Charge of the Cleveland DEA.

Last year, what is believed to be the largest meth bust in the state’s history happened in Boston Heights. The Drug Enforcement Agency confiscated 142 pounds of the drug. Now, within just the last few months, two more seizures found a combined 150 pounds of meth were confiscated by DEA Agents.

There is an increase in the drug and a decrease in meth labs, Martin said.

Martin said Mexican cartels are to blame for the surge of the potent drug.

“When we are seizing those qualities, it impacts the cartel and their ability to operate when they are losing that much product,” said Martin.

In 2014, statistics put Ohio in the top ten states for meth labs.

“Summit county was basically the top in the state of Ohio,” said Inspector Bill Holland with the Summit County Sheriff’s Department.

“We’re seeing a resurgence of this drug, but we’re not seeing the labs,” he said.

According to the Ohio Bureau of Criminal Investigation, in 2016,the bureau was part of cleaning up 286 meth labs, last year, just 28.

 

FREEDOM: Reflection By An Incarcerated Innocent

FREEDOM: Reflection By An Incarcerated Innocent

www.doctorsofcourage.org/freedom-reflection-by-an-incarcerated-innocent/

The day is picturesque for July… White fluffy clouds in the sky, the sun shining bright and beautiful, the warmth can be felt through the tiny window to his room. His room, a man sits alone in a cell reflecting on his 20+ year career of giving his time and talents to the betterment of humanity, its health and well- being. He’s been at the beside when a newborn baby has been brought into this world, taken its first breath, and shared in the joy and celebration of the family as they fulfilled the Great Command to “Go forth and multiply…”; but also held the hand of the dying as they passed from this life into the next, taken their final breath, and shared in the sorrow and grief of the family as they lament the fact that “Life is but a vapor….”. He sits in a cell reflecting on those moments and every memorable life-changing moment in between. A man who has been prolific enough in his own career, yet lucky enough to have impacted the careers of many of his peers through an extensive resume of teaching, research, and consulting. He is sitting in a cell in K Block after being accused, yes accused and not convicted of what is a political argument. Not for breaking a law or a scientific fact, but a political judgement of his medical opinion.

No, this story in not taking place in Russia or China, but it is unfolding right here, right now on the 4th of July in the United States of America. Independence Day, the day we celebrate “FREEDOM” and everything that supposedly separates us from the afore-mentioned countries and every other country on this planet we, as the human race, calls home.

The guy in the cell is me, Jeffrey W. Young, Jr MSN FNP APN-BC, and I’m not alone…. not truly alone.   I am surrounded by many, many other men (detainees) on the BLOCK in a Federal holding facility in the State of Tennessee.

FREEDOM: a concept we think or at least I thought I had or understood, until it was taken away. Now in the fourth decade of my life, sadly, I have come to realize that we do not live in a FREE country and that you are truly GUILTY until proven innocent. This contradicts everything I believed in and was ever taught.

The average American citizen today is busy with picnic plans, family activities, beer, hotdogs, and apple pie; and are completely unaware of the blatant abuse of power currently going on by certain branches of government. Recently the American people have been horrified and outraged by the images of “immigrant detainees” and their plight unfolding on TV right in front of them. Here is a rude awakening, they are “federal detainees” as are myself and all of my new “friends”.

“POWER CORRUPTS…ABSOLUTE POWER CORRUPTS ABSOLUTELY” — Charles Colton

We as Americans have been so afraid of losing our FREEDOM to a foreign power that we have silently consented to our FREEDOM being taken away, as Premier Khrushchev predicted at the United Nations in the 1960’s, by powers from within “without firing a shot”. You might say… “This couldn’t happen to me, and you are just being dramatic”. Yes, I too used to be an idealistic American. In fact, I raised money for, promoted, befriended, and voted for the very Congressman that became a Federal judge that subsequently signed the warrant for the Gestapo style raid on my office and home. RAID, yes a raid, with machine guns drawn and battering rams in hand. Came into my office with machine guns at the ready, putting patients and their families on the floor, children on the floor with machine guns to their heads, raiders screaming “GET DOWN and STAY DOWN!!!!”. Again, this is not a scene from a World War II movie, there wasn’t SS or Swastika arm bands on the soldiers; this took place in a rural God fearing town in West Tennessee in the United States of America, and not in the 1940’s, but 2017.

For the last 2 plus years, I have been reinventing myself and my practice trying hard not to abandon my passion and calling, attempting to meet the needs of my patients; yet conscious of the climate change and the systematic removal of what has been instilled into us over centuries of medicine, but especially in the last 19 years, known as the Patient’s Bill of Rights and the Right of every patient to be pain free. We were taught that pain was the fifth vital sign and instructed to take it as seriously as we took heart rate, blood pressure, temperature, and respiratory rate (oxygen status). However, we were never given an objective tool to quantify this subjective measure. We were told, “pain is what the patient says it is” and given the 1-10 pain scale and “the faces board” ranging from happy to sad. And with these tools in hand asked to treat patients and penalized and threatened with lawsuits if we did not comply. Fast forward nearly two decades later and now Health Care professionals are being prosecuted and being jailed and imprisoned for doing exactly what we were trained to do.

I have not written a single opioid pain pill over a two and a half year period of time, yet on April 17th, 2019; after spending the evening with my son for his 15th birthday, I was arrested in my home in front of my son with agents jokingly asking me “how was the concert last night”. Apparently we had been followed. Yes, in the United States of America.

Since that day I have unfortunately learned about the “unrule of law”. How that the law is NOT a line engraved in marble, immoveable and unchangeable; but rather, the law is like the string of an electric guitar, it is fixed at both ends and can be bent and manipulated to play a certain tune. A tune the powers that be would like for you to hear.   The lawyers being the modern day “axe men” or virtuosos. The lawyer that plays the best tune wins.   The Federal government and its unlimited resources enjoy a certain “style of music” and if you don’t play their “tune” you lose. Song as old as time.

So here I am, on this Independence (FREEDOM) Day, yet another holiday “locked-up on the Block” away from my son and other family and friends; awaiting my chance to prove my innocence of something that isn’t even a crime, but the government’s misinterpretation of the Controlled Substance Act (CSA) to further a political agenda. Unable, by nature of being incarcerated, of mounting a defense I would be able to coordinate if I were on the “outside”.   This “stacking of the deck” in the government’s favor assures them to maintain their 98% conviction rate (actually a plea deal rate…. all men long to be FREE).   2% of the population have to fortitude to play the game out.   Yes, we are still talking about The United States.

“The bar for criminality is high, a

Convicted Nurse Practitioner

nd for criminality to exist there must be knowledge of, and willful intent to commit a crime.”

–Robert Mueller (The Mueller Report)

I pray for the fortitude and strength to see this through to its JUST conclusion….

God Bless America,

Jeffrey W. Young, Jr., MSN FNP APN-BC.

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