“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
Tough proposed disciplinary regulations aimed at curtailing overprescription of opioid painkillers would be eased considerably under a recommendation approved Wednesday by a subcommittee of the Nevada State Board of Medical Examiners.
Instead of the strict rules contained in draft regulations made public after the Prescription Drug Abuse Prevention Act took effect on Jan. 1, the subcommittee will recommend that the consequences for violations of the law will be left to the board’s discretion, based on a prescriber’s “good faith attempts at compliance.”
The original draft created an uproar at a January workshop among doctors who said the law and regulations didn’t adequately define the types of conduct that could lead to penalties or even the loss of their medical licenses.
In response, the medical board created a committee of about 20 doctors, lawyers and health care leaders to look at possible amendments to the regulations, leading to the recommendation approved Wednesday.
The law, passed in the 2017 Legislative session, mandates added paperwork for doctors prescribing opioids. The original regulations said doctors could lose their licences after five violations, even if they were clerical, like forgetting to pull up a patient’s prescription history, and had no direct impact the patient’s safety.
Discipline not required
Both doctors and patients have said in the four months since its implementation, the law has prevented some doctors from prescribing opioids for patients at all, regardless of the legitimacy of their needs.
The proposed regulation adheres to the board’s existing disciplinary process for other laws governing prescribers and gives the medical board the option to abstain from disciplining a doctor if members deem it appropriate.
It also mandates that a doctor who violates the law perform continuing medical education coursework.
“I think what the Legislature tried to do was come up with a response to an obvious issue, but in doing so, they created another set of concerns and worries among the providers, and that was the fear they were going to somehow be held accountable for things beyond the control,” said Dr. Victor Muro, chairman of the subcommittee and a medical board member. “I think what the subcommittee tried to do was address the issues … because the reality of it is that one of the unintended consequences was the continuity of care was disrupted.”
In addition to the disciplinary regulation, the subcommittee plans to recommend to the Board of Pharmacy a regulation to simplify the informed consent and patient medication agreement forms required by the law. Doctors have expressed concerns that they’d have to create additional paperwork to switch a patient’s prescription from one opioid medication to another, but the regulation would create a blanket form for any opioid medication.
If the Board of Medical Examiners approves the recommended regulation at its June meeting, it will be discussed at a public workshop and a hearing before it heads to the state Legislative Commission for approval. Catherine O’Mara, a committee member and executive director of the Nevada State Medical Association, said she expects the regulation to be in place by early fall.
Still, the committee acknowledged at Wednesday’s meeting that while the regulation would clarify how doctors would be disciplined for violating the law, there would need to be changes to the legislation itself in the 2019 session, including clarification as to whether all controlled substance prescribing is regulated, or just prescribing painkillers.
“I think there’s a lot of things that have to be addressed probably in the next session,” Muro said. “I think what we’re trying to do here is try to provide a little guidance in the interim.”
The Prescription Drug Abuse Prevention Act limits initial opioid prescriptions to two weeks and requires doctors to perform patient risk assessments before prescribing.
After one month of prescribing, doctors and patients must enter into written prescription agreements.
Three months in, doctors should have a diagnosis for the patient’s pain.
A doctor shouldn’t prescribe more than a one-year supply of a drug within 365 days, according to the law.
Responsible for 115 deaths each day, the opioid epidemic continues to devastate the nation. The death rate from these drugs has nearly quadrupled since 1999, and continues to rise. Nearly half of these opioid-related deaths—46 each day— were caused by a prescription opioid.
Prescription opioids (e.g., oxycodone, hydrocodone, methadone) are used to treat moderate to severe pain, and can provide effective pain management when prescribed and taken as directed. However, prescription opioids can also be misused and lead to addiction, death, job loss and a host of other problems, taking a significant human and financial toll on individuals, families, communities and states.
State lawmakers are crafting innovative policies—engaging health, criminal justice, human services and other sectors—to address this public health crisis while also ensuring appropriate access to pain management. This report provides an overview of state legislation setting guidelines for, or limits on, opioid prescriptions. As of early April 2018, at least 28 states have enacted legislation related to opioid prescription limits.
The opioid epidemic is fueled by misuse of prescription and illicit opioids (e.g., heroin and fentanyl). Research indicates that the majority of illicit users first misused prescription opioids. According to the Centers for Disease Control and Prevention (CDC), there has been a significant increase in opioid prescriptions for pain since 1999, while the amount of pain that Americans report has not changed much overall. While new research found that the amount of opioids prescribed decreased between 2010 and 2015, it remains about three times higher than in 1999.
In response to the epidemic, the CDC released the “Guideline for Prescribing Opioids for Chronic Pain” in March 2016. The guideline offers primary care providers a set of voluntary, evidence-based recommendations for prescribing opioids to patients 18 years or older in primary care settings. It focuses on chronic pain treatment, and does not apply to patients in active cancer treatment, palliative care or end-of-life care. The recommendations are based on existing scientific evidence. For example, higher doses of opioids are associated with higher risk of overdose and death. Even relatively low dosages—considered to be 20 to 50 morphine milligram equivalents (MME) per day—increase risk. As such, the guideline recommends starting with the lowest effective dosage, and carefully considering dosages above 50 or 90 MMEs per day. For treating acute pain, the guideline recommends a quantity no greater than what is needed for the expected duration of pain severe enough to require opioids, specifying that three days or less will often be sufficient and more than seven days will rarely be needed.
Using opioids to treat acute pain can lead to long-term use. The likelihood of long-term use increases based on the length of the initial prescription, according to the CDC. In fact, the likelihood of long-term use increases sharply after the third and fifth days of taking a prescription, and spikes again after the 31st day. According to the CDC, long- term use also increases with a second prescription or refill, a 700 morphine milligram equivalents (MME) cumulative dose, and an initial 10- or 30-day supply.
Improving prescribing practices and the way pain is treated is one avenue to help prevent misuse, addiction and overdose, while ensuring legitimate access to pain management. In recent years, a number of states have enacted policies related to prescribing opioids, some of which align with certain recommendations in the CDC Guideline.
The opioid stewardship bill advanced in the state Senate on Tuesday after the bill’s author replaced the “penny-a-pill” fee on opioid sales with an
annual $20 million in set registration fees to be paid by pharmaceutical companies.
The funding would pay for programs to address the opioid overdose epidemic, as well as to pay some of the cost, currently born by counties, of caring for families affected by addiction.
While the previous version of the bill included a fee per each opioid milligram sold in the state, and more depending on the type of opioid, the amended legislation would assess fees on manufacturers and wholesalers proportionately based on their opioid sales.
The bill’s author Sen. Julie Rosen, R-Vernon Center, said it’s modeled on a New York state law, which is expected to raise about $100 million annually from drug manufacturers and distributors.
“This one actually gets to the heart of what we want to,” Rosen said. “We need some accountability coming back from the manufacturers and wholesalers, but it also does it more fairly and precisely.”
The change in the Senate bill’s funding is intended to address opposition that the penny-a-pill fee on opioids amounted to a new tax.
I don’t have to have that argument about a fee versus a tax,” Rosen said during Tuesday’s hearing. “This is the cost of doing business.”
Rosen said she wanted to avoid using taxpayer money to address the fallout of the opioid epidemic, which many attribute to overprescribing of opioid painkillers.
“I just feel really adamant against using general fund dollars to pay for someone else’s mistakes,” Rosen said of pharmaceutical companies. “They’ve been sued. They’ve settled in many court cases, and I just feel like this is a very fair way of doing it.”
Under the new version of the Senate bill, the Minnesota Board of Pharmacy would assess $12 million every fiscal year from manufacturers based on the opioids the companies report selling. Wholesalers would be assessed a total of $8 million.
The bill includes almost $1 million in funding for state agencies, including for drug scientists at the Minnesota Bureau of Criminal Apprehension. The remaining funds would be split between county social services and grants awarded by the stewardship council. The bulk of the funding will go into effect in fiscal year 2020.
The 18-member Opiate Stewardship Advisory Council includes lawmakers, doctors, a representative of opioid manufacturers and a member appointed by the Steve Rummler Hope Network, a group that has pushed for more funding for prevention and treatment of opioid abuse.
Lexi Reed Holtum of the group said it’s important that the bill still holds the pharmaceutical industry accountable.
“It’s not as direct a fee as we were hoping for,” Reed Holtum said, “but given that it still creates a dedicated fund that’s paid for by pharma, we’re really happy about that.”
Some groups representing business and pharmaceutical companies opposed the previous version of the legislation. A spokesperson for the industry group Pharmaceutical Research and Manufacturers of America (PhRMA) said the group is still reviewing the language in the amended bill.
Americans for Prosperity opposes the legislation. State director Jason Flohrs said the registration fee would raise costs for patients.
“Regardless of what you call it or where in the system it is imposed, this is still government imposing additional cost burdens on individuals and families, many of whom are already struggling to afford health care,” Flohrs said.
The Senate version of the bill advanced unanimously to the Rules and Administration Committee. The House version includes funding from the state general fund. If both bills pass, the differences will be worked out in conference committee.
HealthDay News — Almost 63% of patients did not use opioids after having an elective procedure, according to a study presented at the annual meeting of the American Surgical Association, held from April 19 to 21 in Phoenix.
Cornelius A. Thiels, DO, from the Mayo Clinic in Rochester, Minn., and colleagues conducted a prospective survey of patients to investigate postoperative opioid use. In total, 2550 patients undergoing 25 elective procedures were asked to complete a 29-question telephone interview survey 21 to 35 days after being discharged; 1907 patients completed the survey.
The researchers found that 92.2% of patients received discharge opioids. These were converted into oral morphine equivalents (OMEs). After discharge, a median of 44 OMEs were consumed. On average, 62.7% of prescribed opioids were unused. Thirty-one percent of patients used no opioids, and 52.3% required <50 OMEs. The refill rates varied from 1.7 to 71.4% for laparoscopic inguinal hernia and lumbar fusion, respectively. Most patients (90.2%) were satisfied with their post-discharge pain control. More than one-quarter (28.2%) reported being prescribed too many opioids, while 8.3% reported not being prescribed enough. Remaining opioids were disposed of by only 7.5% of patients.
“This research provides a road map for physicians and surgical departments,” a coauthor said in a statement. “It shows there are certain surgeries and types of patients who are likely receiving significantly more opioids than needed.”
Dozens of people died and hundreds of others fell ill during the 2012 fungal meningitis outbreak that began in a Framingham compounding pharmacy.
But should jurors in the latest trial against former pharmacy employees hear the devastating details of what is considered one of the largest public health crises ever caused by a pharmaceutical product?
Prosecutors and defense lawyers for nine pharmacists, technicians, and executives sparred over that question Monday at a hearing in US District Court in Boston.
The nine defendants are the lesser-known actors charged in the tragedy involving the New England Compounding Center during the summer of 2012, when prosecutors say contaminated, expired, and untested drugs were mislabeled and shipped to doctors, clinics, and hospitals across the country.They face charges that include mail fraud and racketeering in connection with the scandal and are scheduled to go on trial in October. But their lawyers contend they had no role in producing the batches of a contaminated steroid that caused the deadly outbreak. Some had worked for years at the company, while others had only been there a few months when federal officials launched their investigation.
“The outbreak has nothing to do with the charges against them,” said Dana McSherry, who is representing Joseph M. Evanosky, a pharmacist who worked at NECC from April 2011 to October 2012.
The nine defendants had filed a joint motion asking that US District Judge Richard G. Stearns bar testimony about the tainted vials of the steroid, methylprednisolone acetate, and the harm they caused.
The man responsible for compounding that drug, pharmacy supervisor Glenn Chin, was convicted last fall, defense lawyers argued. Chin began serving an eight-year sentence for racketeering and fraud in April. NECC’s former owner, Barry Cadden, was convicted of fraud and racketeering in March 2017 and was sentenced to nine years in prison.
“This is not Cadden-Chin, round three,” McSherry said. “These are different defendants, different charges.”
Cadden and Chin were both acquitted of second-degree murder charges.
Assistant US Attorney George P. Varghese said it’s critical that jurors know about the fallout of the steroid’s production so they can understand why the federal government launched a massive investigation into the pharmacy.
The remaining defendants may not have been responsible for production of the steroid, but Varghese said they used the same unsafe practices to produce and ship other drugs.
“We are not seeking to inflame the jury,” Varghese said. “We are trying to demonstrate the story of what happened in this case.”
Varghese said prosecutors plan to seek testimony from Centers for Disease Control and Prevention and Food and Drug Administration officials but will not call victims or their families as witnesses.
Prosecutors have described NECC as a “fraudulent criminal enterprise” that produced substandard drugs and marketed them as the safest in the country. They say many of the remaining defendants conspired with Cadden and Chin to carry out the scheme, but defense lawyers say the government went too far in charging their clients for what are essentially civil regulatory violations.
In 2012, investigators from the CDC and the FDA found that NECC sent out vials of mold-tainted steroids that were injected into the spines of patients, many of whom suffered strokes. Those who survived continue to be afflicted by pain, headaches, and memory loss. Many now rely on canes and wheelchairs.
In 2014, prosecutors indicted 14 people in connection with the outbreak, which authorities said caused the deaths of 64 people and infected about 800 patients.
Stearns seemed to agree with defense lawyers that it could be problematic to include evidence of the deaths and illnesses at a trial for defendants who were not accused of producing the deadly steroid.
But he said prosecutors have a strong argument for why the jury may need the context of the outbreak to understand why the pharmacy was investigated in the first place.
McSherry countered that it is not necessary to tell the jurors of the deaths and illnesses that occurred, since the defense does not plan to argue that there was no reason for federal agencies to investigate the pharmacy.
“That’s fair,” Stearns replied.
But Varghese said prosecutors need that background to counter the likely defense argument that they overreached in charging the defendants with racketeering or conspiracy.
He alluded to the second-degree murder acquittals of Cadden and Chin to show that jurors in those trials, who were shown photos of the victims and heard wrenching testimony about how they died, were still able to assess the evidence objectively.
The government is seeking almost $74 million from Cadden in restitution for the victims.
Besides Evanosky, the remaining defendants are Gregory A. Conigliaro, a former owner and director of NECC; Sharon P. Carter, former director of operations; Scott M. Connolly, a pharmacy technician; and five other pharmacists: Chin’s wife, Kathy; Gene Svirskiy; Christopher M. Leary; Alla V. Stepanets; and Michelle L. Thomas.
Fatal overdoses of prescription opioids were rare before 1999. Then doctors, influenced by pharmaceutical industry marketing, began prescribing them for chronic non-cancer pain. By the end of 2016, prescription opioids — not illicit heroin or fentanyl — had claimed 200,000 lives.
Now, at last, the opioid wave has crested. Per capita usage declined for the sixth straight year in 2017, according to IQVIA Institute for Human Data Science , a health-care consulting group. Changes in public policy, including long-awaited prescribing guidelines issued by the Centers for Disease Control and Prevention (CDC) in March 2016, promise to sustain this life-saving progress.
Or maybe they’ll lead to human rights violations. Believe it or not, that’s the premise of a new investigation by the New York-based nonprofit Human Rights Watch (HRW), known for its exposés of war crimes around the world.
HRW is seeking evidence that the CDC guidelines and other efforts to modulate opioid prescribing result in patients being cut off from vital medication, in violation of their right to appropriate health care.
The group “is looking for testimonials from chronic pain patients who have been forced or encouraged to stop their opioid medication by physicians or pharmacists,” the Pain News Network reported in March.
“The CDC clearly knows what’s going on and they haven’t taken any real action to say, ‘That is not appropriate, involuntarily forcing people off their medications. That’s not what we recommended,’ ” Diederik Lohmann, director of health and human rights for HRW, told the network, which says two-thirds of its readers take opioids, mostly for chronic, non-cancer pain. “When a government puts in place regulations that make it almost impossible for a physician to prescribe an essential medication, or for a pharmacist to stock the medication, or for a patient to fill their prescriptions, that becomes a human rights issue.”
Human Rights Watch is not alone; a recent cover story of the libertarian magazine Reason denounced “America’s war on pain pills.” And, of course, patients who have become dependent on opioids must be treated compassionately.
But even after the recent decline in prescriptions, the U.S. opioid rate of consumption in 2017 — 676 morphine milligram equivalents per adult — was five times the 1992 rate. It’s double or triple that of other advanced countries. People who really need them can get licit opioids in the United States.
And the drugs still killed 46 people a day in 2016, according to the CDC.
In any case, alleged unintended consequences of justifiable and, indeed, moderate public-health policies just do not belong in the same moral conversation as deliberate human rights violations such as police brutality or torture.
Article 12 of the International Covenant on Economic, Social and Cultural Rights does indeed exhort governments to guarantee the “highest attainable standard” of health; in that sense, there is a human right to health. Whether it can be defined with sufficient objectivity for this situation is another story. Assuring health is exactly what the CDC is trying to do — not through “regulations,” but through evidence-based recommendations.
To be sure, HRW acknowledges that opioids have been overprescribed in the past, in part due to deceptive industry marketing; a key focus of its current research is ensuring non-opioid alternatives for patients weaned off the drugs, Lohmann told me.
One ought not to prejudge the HRW report, due later this year, even if Lohmann’s comments to the Pain News Network implied that the CDC is blameworthy, and even if the organization funding the study, the U.S. Cancer Pain Relief Committee, is headed by a five-member board of pain specialists who are well-known advocates of opioid use for chronic non-cancer pain.
Two of them, Russell Portenoy and Richard Payne, have received financial support from opioid manufacturers. In late 2015, Payne spoke out against the CDC guidelines in a government advisory group’s deliberations before they were adopted. (Efforts to reach board members were unsuccessful.)
Note that the CDC guidelines specifically address opioid use for non-cancer pain only. The government encourages palliative care for cancer and hospice patients.
The U.S. Cancer Pain Relief Committee has previously underwritten HRW reports on the developing world, the theme of which is that AIDS and cancer patients are being denied access to morphine due to international and national rules intended to prevent opioid misuse. Palliative care in poor countries is a legitimate concern — among the many urgent health-care deficits that such countries face.
Here’s another legitimate concern: Poor and middle-income countries may be vulnerable to the same kind of pro-opioid campaign that wreaked such havoc in the United States.
Mundipharma, a network of companies controlled by the same closely held family business that introduced Purdue Pharma’s OxyContin to the United States, is engaged in aggressive opioid marketing in China, Colombia, Egypt, Mexico and the Phillipines, according to a recent Los Angeles Times report.
As Keith Humphreys, Jonathan P. Caulkins and Vanda Felbab-Brown write in the May/June issue of Foreign Affairs, the U.S. experience shows that “legal drugs pushed by corporations can bring death on a scale vastly surpassing the effects of illegal ones.” And no human right is more important than the right to live.
AUSTIN — As Texas House lawmakers investigate what the state’s response should be to the growing opioid crisis here and around the nation, tort reformers are growing concerned that trial lawyers are “unethically” recruiting clients to go after big pharmaceutical companies.
Chairman of the Select Committee on Opioids and Substance Abuse, state Rep. Four Price, R-Amarillo, was asked about “ambulance chasing” attorneys by Jay Leeson, host of the Other Side of Texas Radio Show based in Lubbock.
In response, Price pointed out that the committee’s study of the issue – as laid out by retiring Speaker Joe Straus – does not include looking at litigation.
That’s even though some counties around the state including Upshur, Bexar and Harris have filed suit against manufacturers of opioids seeking to recoup uncompensated care costs.
Price noted that at least $350 million in opioid overdose-related costs have been racked up at local emergency rooms.
“If you really study these issues, there’s a shared level of responsibility up and down that spectrum from the manufactures to the prescribers to the distributors to the patients themselves,” he said.
Price said the committee will take its time in coming up with recommendations by November for the next Legislature to consider. “Not all of big pharma’s going to love our recommendations. I’m sure not all prescribers or patients will love our recommendations,” he said.
The full story can be found in the Quorum Report. Copyright 2018, Harvey Kronberg,http://quorumreport.com/index.cfm, All rights are reserved. This story is presented as part of the Houston Chronicle’s collaboration with Quorum Report. For inside information on Texas politics and government and to sign up for real-time updates, go here.
Alder Hey Children’s Hospital in Liverpool, England, became notorious in international headlines last week as the site of the legal “execution” of a stricken toddler over the wishes of his parents, as well supporters of the parents on both sides of the Atlantic, and even in the Holy See.
But the hospital had a well-documented history of being the scene of abusive medical practices long before it admitted young Alfie Evans into what became his death chamber.
As the pro-life group Live Action reminded the public in a social media post Friday, Alder Hey was at the center of a British National Health Service scandal in the 1990s that involved hospitals throughout the national socialized medicine network harvesting and storing the organs of deceased children without the knowledge of the children’s parents.
A summary of a government report about the scandal, published by the U.K. Guardian in 2001, noted that the dead children’s “parents were distraught to find that thousands of body parts had been removed and kept in hospital storage.”
According to The Guardian, the organs in those cases were removed during autopsies, a standard practice. But the families were never informed that parts of the bodies of their children had been kept for research purposes.
But Alder Hey took that a step further by getting paid for some of the body parts it harvested.
The hospital actually transferred the thymus glands removed from living children during heart surgery to the French vaccine maker Aventis Pasteur in exchange for a small “donation.”
The hospital received about five British pounds for each gland (worth about $7.50 to $10 USD). An exact number of the organs wasn’t reported, but it was believed to be in the hundreds.
The thymus gland is an important part of the body’s immune system, so it’s easy to see why a vaccine research firm would be interested in a steady supply — even if the organs came from still-living children and essentially sold without the knowledge or consent of those children’s parents.
In January 2001, an Alder Hey spokeswoman confirmed to The Guardian the exchanges had taken place.
“The hospital can confirm that for a brief period between 1991 and 1993, (thymus glands) were made available to a pharmaceutical company for research, and that we are aware that during that period contributions were made to the trust’s cardiac department,” she told the newspaper.
At the time of that report, a pediatrician associated with Alder Hey tried to justify the obviously ghoulish practice of removing bodily organs from living children and selling them without the knowledge of the parents by saying the company produced a drug that helped treat children with anemia.
Maybe all of that is true. Obviously, medical research involves methods laypeople would consider gruesome, and the products pharmaceutical companies manufacture obviously save lives.
But the fact remains that a British hospital, part of the country’s vaunted system of socialized medicine, was harvesting organs from living children and selling them to a commercial company without the knowledge of the people who really mattered.
As Live Action pointed out, the pediatrician’s argument sounded awfully similar to the logic used by abortion giant Planned Parenthood after it was caught in a series of undercover videos literally selling the organs of children dismembered during abortions.
What it comes down to is this: The British hospital that essentially killed a helpless toddler last week by removing the boy from life support, then refusing to allow his parents to take him to seek treatment that was available elsewhere, has a documented history of shamefully using the bodies of its child patients.
And it did it by taking a step even further than other hospitals in Britain’s National Health Service.
Any American who might still be undecided about Obamacare and its death panels, or thinking about backing someone with the beliefs of Bernie “Single Payer” Sanders, should be watching the death of Alfie Evans and the hospital where it took place carefully.
Drastic cuts in what Illinois pharmacies are paid for filling Medicaid patients’ prescriptions will cause many to lay off employees or close in coming months, pharmacy advocates say.
The financial crisis for owners of independent and small-chain pharmacies has accelerated since the April 1 expansion of the state’s Medicaid managed-care program to all 102 Illinois counties, according to the Illinois Pharmacists Association.
“We’ve got to fix this,” said Garth Reynolds, executive director of the Springfield-based association. “This is far and away the most egregious situation we’ve seen.”
Many owners of the state’s more than 500 independent pharmacies and smaller chains — including those in the Springfield area — are being paid less than the “acquisition cost,” or wholesale price, of the medicines they dispense to Medicaid patients.
Reynolds said pharmacies also have seen their per-prescription “dispensing fee” from Medicaid — designed to cover professional services — drop from $5.50 for generics and $2.40 for brand-name drugs under the previous “fee-for-service” system to the current 45 cents per prescription.
As a result, many pharmacy owners say their overall payments from Medicaid have dropped by half or more because of rate cuts instituted by companies known as pharmacy benefit managers, or PBMs.
At least one of those PBMs, CVS Caremark, pharmacy benefit manager for the huge CVS Pharmacy chain, appears to be working with CVS Pharmacy to put smaller pharmacies out of business so CVS can acquire them, Reynolds said.
“It’s kind of a predatory market practice and misuse of state tax dollars,” he said.
CVS officials didn’t respond to requests for comment.
PBMs are hired by private companies called managed-care organizations, or MCOs, to process payments to pharmacies. MCOs have contracts with the state to carry out the Medicaid managed-care program now serving 80 percent, or 2.7 million, of Illinois’ 3.14 million Medicaid recipients.
The Illinois Department of Healthcare and Family Services has said Gov. Bruce Rauner’s expansion, or “reboot,” of Medicaid managed care will lead to annual savings of $200 million to $300 million, or more than $1 billion in savings over the life of the four-year contract for HealthChoice Illinois.
A bill that would require Healthcare and Family Services (HFS) to pay pharmacies “fair and reasonable” reimbursement rates — at least equal to the former fee-for-service rates — has bipartisan support and passed the Illinois House, 87-16, on Thursday.
Those voting “yes” to House Bill 3479 included Reps. Sara Wojcicki Jimenez, R-Leland Grove; Tim Butler, R-Springfield; and Sue Scherer, D-Decatur. Rep. Avery Bourne, R-Raymond, was absent from the vote but is listed as a co-sponsor of the bill, which now will be considered by the Senate.
Health and Family Services, an agency controlled by the Republican governor, opposes the bill but didn’t respond to a request for comment from The State Journal-Register.
Also opposing the legislation are two organizations representing private companies that are part of the Medicaid managed-care program.
Samantha Olds Frey, executive director of the Illinois Association of Medicaid Health Plans, said in a written statement that the bill could require Medicaid plans to pay above fee-for-service rates.
She said the bill “removes all incentive for all pharmacies throughout the state to acquire pharmaceuticals in a cost-efficient manner.”
Members of Frey’s association “see great value in independent pharmacies, especially those in rural communities throughout the state,” she said. “No one can argue that they are not an important part of our health-care system. However, this bill does not just address independent pharmacies. It requires more taxpayer dollars going to chains and ‘big-box’ stores.”
Officials at Deerfield-based Walgreens — another of the state’s largest pharmacy chains — declined comment.
The Pharmaceutical Care Management Association, based in Washington, D.C., and representing pharmacy benefit managers, said in a written statement that HB 3479 would “grant a ‘blank check’ to independent drug stores by requiring higher payments for prescription drugs in Medicaid while removing incentives to dispense lower-priced, equally effective options for patients.”
The proposed law, according to the PCMA, “pads the profit margins of Illinois independent drug stores at a time when consumers are concerned about rising health costs and the state faces serious budget challenges.”
Reynolds responded that pharmacy benefit managers are the ones getting a blank check from the state because of the state’s lack of oversight.
“We’re trying to keep pharmacies operational to be available to patients in their communities,” he said.
Pharmacist David Falk, who supports HB 3479, is the owner of the Decatur-based Sav-Mor Pharmacy chain, which includes stores in Virden, Nokomis and 11 other downstate communities.
Falk said his drug stores posted an average profit per Medicaid prescription of $6.77 under the fee-for-service system. That profit took into account the wholesale cost of medicines and dispensing fees.
Under Rauner’s reboot of managed care, however, Falk’s average profit has dropped to 89 cents per Medicaid prescription. Depending on the store, Medicaid represents between 18 percent and 42 percent of his stores’ total revenue, Falk said.
Unless the situation changes, he said, “I will go out of business.”
Two of his pharmacies — in Neoga and Toledo, both in Cumberland County, northeast of Effingham — “won’t make it until the end of the year,” he said.
The financial pain has been similar for Michelle Dyer, a pharmacist and owner of Michelle’s Pharmacies in Carlinville, Gillespie and Bunker Hill, where Medicaid makes up about 40 percent of total revenues.
“I can’t pay my bills,” she said, adding that she has had to borrow to make ends meet.
Pharmacist Byron Berry, who owns and operates Pharmacy Plus sites in Carrollton, Roodhouse, Winchester and Barry, gets 25 percent to 35 percent of his revenues from Medicaid.
It’s frustrating that state contracts conceal the profits being made by pharmacy benefit managers for squeezing pharmacies, Berry said.
It’s unknown how much of that “savings” is being passed on to managed-care organizations or the state, he said. Also unknown, he said, is how much money pharmacy benefit managers are receiving in “rebates” from pharmaceutical manufacturers to pad their own profits.
The pharmacy owners said it’s wrong when CVS Caremark hits small pharmacies with low payment rates for serving Medicaid patients and CVS Pharmacy follows up with letters to those same pharmacies containing offers to purchase.
A copy of one such letter, distributed to lawmakers by the Illinois Pharmacists Association, says CVS wants to ease the stress of what the letter describes as “mounting challenges” that include “declining reimbursements.”
Not all pharmacies that end up going out of business will end up being acquired, Berry said. Some will close and leave large swaths of downstate Illinois without a local pharmacy, he said.
“We take care of our people in these small towns,” Berry said.
Several states are taking a closer look at how Medicaid managed care is affecting small pharmacies, Reynolds said. Arkansas lawmakers and that state’s governor recently approved a new law to regulate pharmacy benefit managers.
At an Illinois House subcommittee last week, several lawmakers were receptive to pharmacy owners’ complaints about pharmacy benefit managers. Lawmakers said fewer pharmacies will mean less access to care for patients.
“What is the patient supposed to do while we’re searching around for the best deal?” asked Rep. Mary Flowers, D-Chicago.
“We’re talking about people’s lives. … We need the pharmacists. We do not need the middleman; they are not accountable to anyone.”
The payment cuts threaten the future of pharmacist Beax Cole’s Medicine Shoppe pharmacies in Springfield and Jacksonville. Those stores receive up to one-quarter of their revenues from Medicaid, Cole said.
Rachel Hinkle of Auburn said the Springfield Medicine Shoppe has provided expensive, compounded medicines to help her 8-year-old son, Matthew, deal with neurological problems and a genetic condition known as Angelman syndrome.
Cole has had to wait months for thousands of dollars in reimbursements for the life-sustaining medicines under the fee-for-service Medicaid system, and now he said he is having problems getting the medicines covered under the managed-care reboot.
Hinkle she doesn’t know what she would do if she lost access to the Medicine Shoppe.
“Thank God they think of the patient,” she said. “They just want to make sure Matthew is taken care of. Shouldn’t people be the priority?”
Medicare and Medicaid are suppose to grant beneficiaries the “freedom of choice” of providers… Of course, if the bureaucracy reduces reimbursement to a point it drives out many of the providers… “freedom of choice” may come down to a few providers – mostly corporate providers that may – or may not – meet the pt’s needs.
It is generally considered that it costs $12.00 to fill a prescription – to cover all the costs of the pharmacy and according to this article, the state of Illinois has reduced “profits” to $0.89. While such entities – like CVS Health/Caremark – a PBM… whose administrative costs are not accountable to anyone… is also a competitor to many of the smaller pharmacies that they are determining the profitability of those competitors.
Presuming the $12/Rx overhead cost of filling a prescription. Under this program CVS pharmacies were paid FIVE TIMES what it cost to fill a prescription. Is this just predatory business practices or anti-competitive behavior ?
Most people are aware of the types of drugs that are federally classified as substances with no medicinal benefit and high abuse potential: heroin, LSD and marijuana are examples of these drugs and they are indeed classified as illegal. The Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) are the two government agencies responsible for classifying drugs.
The FDA recently received a Citizen Petition for Stricter Regulation of Added Sugar “to amend the Drug Schedules to include added sugar to either Schedule I or Schedule II of the Controlled Substances Act.” This idea is not new to many members of the medical community who believe that sugar is a poison.
The implications of scheduling sugar may run deeper and command more gravitas, than one might think. According to the Centers for Disease Control and Prevention (CDC), the U.S. is experiencing an obesity epidemic that results in premature deaths and billions of added healthcare costs to manage diabetes, heart disease and obesity-induced joint destruction.
Sugar unquestionably adds to the prevalence of obesity in America. Therefore, every food product that includes sugar may be contributing to the scope and costs of the obesity epidemic and is accelerating the volume of premature deaths among millions of Americans.
Robert Lustig, a specialist on pediatric hormone disorders and a leading expert in childhood obesity, popularized the claim that sugar is a poison in his “Sugar: The Bitter Truth” lecture.”
According to a New York Times Magazine article, “Is Sugar Toxic?,” Lustig has taken a leadership role in blaming sugar for the increase in obesity and diabetes.
He holds sugar at least partly responsible for the prevalence of many diseases, implicating high-fructose corn syrup (which is actually fructose and glucose) as well sucrose (refined sugar). Studies with laboratory rats, the results of which may also hold true for humans, have convinced him that sugar is toxic.
Time sums up this research, “Lustig and his colleagues think they’ve produced the ‘hard and fast data that sugar is toxic irrespective of its calories and irrespective of weight.’ “
However, there has been controversy surrounding the toxicity of sugar. According to a EcoWatch article, for the past 50 years, the sugar industry has manipulated the science to exonerate sugar and shift the blame to fat for causing disease. The article contends academic scientists were complicit in persuading people to get more of their calories from sugar rather than from fats.
Minimally, many people do seem to crave sugar. Dr. David Samadi, writing for the Huffington Post, says that sugar affects the brain in much the same way as heroin and cocaine. In that sense, he says, sugar is an addictive drug.
In fact, sugar may be as addictive as other substances that are scheduled 1 by the FDA and DEA. Many of us experience great pleasure from eating sweets and continue to ingest them despite the harm they may cause.
This is the classic definition of an addiction. For example, some people claim they are addicted to chocolate; maybe, in fact, they are.
It’s likely that some of us who would refuse to misuse — or even use — highly scheduled drugs continue to perceive the dangers of sugar in a different light than other risky substances. Maybe our perceptions should change.
The CDC has estimated the number of deaths that are attributable to obesity each year to be between 112,000 and 365,000, depending on the calculation. Even if we conservatively take the lesser number, that still represents 3-4 times more deaths than the number of opioid-related deaths in the U.S.
What the FDA and DEA will do with the Citizen Petition for Stricter Regulation of Added Sugar is unknown. However, it is possible that the petition may eventually lead to a class action lawsuit against sugar manufacturers and soft drink producers and their distributors. Has industry been forthright with the American public about the potential harm of sugar? Time will tell.
Meanwhile, we know sugar is a rewarding substance that is abused by millions of Americans every day and has contributed to more than 1 million deaths in the past decade. It will be interesting to see how the debate will evolve and how political and social forces will influence the outcome.
Fortunately, sugar affects all of us differently and for many people it is neither addictive or deadly. Just like many other substances that carry inherent risk, sugar can be safely used in moderation by most people without wreaking havoc on their lives or contributing to their premature deaths.
Lynn R. Webster, M,D. is a vice president of scientific affairs for PRA Health Sciences and consults with Pharma. He is a former president of the American Academy of Pain Medicine. Webster is the author of “The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us.” You can find him on Twitter at @LynnRWebsterMD.
The opioid epidemic is fueled by misuse of prescription and illicit opioids (e.g., heroin and fentanyl). Research indicates that the 
