ACLU is making a difference for those whose rights are most at risk: chronic pain pts NOT CONSIDERED AT RISK ?

Every day we hear new evidence of how the Trump administration’s policies are trampling on people’s rights, ripping families apart, and destroying the very fabric of our democracy.

It’s maddening. But, we can fight back.

With 137 legal actions challenging the Trump administration, the ACLU is making a difference for those whose rights are most at risk.

Here’s the important step we need you to take right now.

Support the ACLU by becoming a Guardian of Liberty with a monthly pledge of $15 or more.

Your monthly support will ensure that ACLU advocates can respond quickly whenever people’s civil liberties are under attack — and keep fighting for as long as it takes.

And thanks to a group of generous donors, your first three monthly Guardian of Liberty gifts will be matched dollar-for-dollar, up to the match limit of $25,000.

That means a monthly gift of $15 will translate to an additional $45 for the ACLU, multiplying your impact on time-sensitive work like protecting the right to vote, challenging Trump’s transgender military ban, fighting for criminal justice reform — to name a few.

With so many assaults on people’s rights coming every day, there couldn’t be a better time for you to act.

Everything we believe in is on the line. Please become a Guardian of Liberty today: aclu.org/GOL

Thanks in advance,

Anthony D. Romero
Executive Director, ACLU

 

do members of Congress every see your correspondence ?

Given today’s technology, one wonders what path a constituent’s correspondence takes.  Each Member of the House represents 710,000 constituents.  Senators’ numbers are a bit different… Since TWO SENATORS represent a state and the most populous state is CALF with 40 million and then there is little old Wyoming  with a 589,000 population.

There may be exceptions, but normally I read about a constituent contacting someone in Congress about denial of chronic pain meds .. only to get back a letter discussing what is being done in fighting the opiate crisis.

I think that it would be interested to see a study on what the constituent correspondence asks and what comes back..  I suspect that we know the answer.. without a study.

Correspondence could take one of two paths… gets scanned into a computer and the computer looks for “key words” in the text and generates a “form letter” based on the key words. Or the same task is done manually using office staff.. to pick the form letter and/or choosing specific form paragraphs to compose a return letter.

In turn, there is data on a spread sheet collected based on the key words for the member of Congress to review. So that they can be “in-sync” with his/her constituent’s concerns.

IF you pay attention to what “big business” does to get things their way on the hill… they hire lobbyists… who does their lobbying IN PERSON.. Many lobbyist firms will generate proposed bills and presents them to member of Congress and ask them to sponsor the bill.

Maybe the chronic pain community needs to come up a “proposed bill” to benefit those in the chronic pain community and ask – IN PERSON – various members of Congress to sponsor/co-sponsor the bill. 

May be a better outcome, than what has been done in the past… ?

 

Looking in the rear view mirror

I have been posting on this blog for SIX YEARS as well as Facebook and Twitter. Reflecting in the rear view mirror of those in the chronic pain community…  numerous people and chronic pain pts have “stepped up” to make things happen.

People have “stepped up” .. with “tons” of enthusiasm.. only to be discouraged because change doesn’t happen in a time frame measured in days or weeks… more like months, quarters and years.. if at all.

People have stated that they have sent letter, emails, faxes or called members of Congress’ offices and or various persons in the media, and typically they get back information about the opiate crisis we are dealing with.

Dozens or hundreds of petitions have been put up on various websites and goals of tens or hundreds or tens of thousands were the goal to have people sign these petitions and in the end.. MAYBE a few hundred would sign them.. given that there is supposedly 100 + million chronic pain pts… the turn out to sign these petitions could only be “measured” as POOR.

There has been a few attempts in getting “demonstrations” at state/federal capitals.  Again, the “body count” considering all the estimated 100 + million chronic pain pts… Again, a poor turn out..

The DEA has raided Dr Tennant’s office a few months ago and there was a “go fund me ” fund to raise money for his legal defense … After about FOUR MONTHS… – as I write this post – 111 separate contributions have been made.

A couple of years ago, another chronic pain pt and myself tried to create a “legal defense fund”.. our goal was to get about 1% if the chronic pain pts to contribute – ONE TIME – the cost of a fast food lunch ($5.00 – $7.50).. after about ONE MONTH… a couple of dozen people had made contributions with a total of around $600. Not even close to the amount needed to fund the creation of a non-profit for the legal defense fund… The contributions were refunded and the project was abandoned.

Maybe this is why when someone looks in our rear view mirror… it appears EMPTY, but that may be the “sanitized picture”.. perhaps the real picture would be a road clutter/clogged with “dead bodies” and “incapacitated bodies ” from all the chronic pain pts that have had their medication reduced or stopped ? I wonder how many of those “bodies” didn’t expect it to HAPPEN TO THEM… they were good little pts…  They had been using the same prescriber for years or decades. If they kept their heads down… everything would be OKAY ?

 

opiate OD dropping by single digits… pts in treatment – DOUBLING !

Opioid prescribing drops largest amount in 25 years

https://www.washingtonexaminer.com/policy/healthcare/opioid-prescribing-drops-largest-amount-in-25-years

The number of opioid painkillers prescribed last year dropped by the largest rates in 25 years, new data show.

IQVIA Institute for Human Data Science, a health data firm, released a report that showed an 8.9 percent drop on average in the number of prescription opioids, such as OxyContin or Vicodin, that were filled by retail and mail-order pharmacies.

All states and the District of Columbia were evaluated for the study and had declines of more than 5 percent. Eighteen states had declines above 10 percent, including Pennsylvania and West Virginia, two states that are among the top five in the country with the highest rates of drug overdose deaths.

 The prescribing drop was 2 percentage points lower than the drop in 2016 and represented a 7.8 percent decline in new patients receiving prescriptions for opioids.

The data also show that the number of people who were prescribed medication to treat addiction, which helps stave off withdrawal symptoms, rose to 82,000 a month, nearly doubling.

“This suggests that healthcare professionals are prescribing opioids less often for pain treatment, but they are actively prescribing [medication-assisted treatment] to address opioid addiction,” said Murray Aitken, the data firm’s senior vice president.

Prescriptions for opioids rose in the 1990s as doctors provided them to patients who were suffering from pain. As addiction and death from overdoses began to climb, government regulators issued more restrictions and waged public awareness campaigns.

Despite those changes and the reduction in prescriptions, deaths from opioids have continued to rise, partly because people replace prescription painkillers with heroin, a cheaper, more available alternative. Government data show that 80 percent of people who take heroin first abused prescription painkillers. Deaths also have surged because heroin is being mixed with fentanyl, a more potent opioid that drug users often don’t know they are taking.

Overdoses from opioids killed more than 42,000 people in 2016, a fivefold increase from roughly two decades earlier. Government data show that roughly 2 million people in the U.S. are addicted to prescription opioids.

How to conduct a AUTHENTIC APOLOGY… even if you don’t mean it ?

 

They claim that with a GRAND JURY…. a prosecutor could get a “ham sandwich” indicted

Trial for doctor linked to Glen Cove overdose begins

Opening statements, undercover video in Day 1 of Belfiore opioid trial

http://liherald.com/stories/feds-merrick-doctor-a-dealer-not-a-healer,102325

The Merrick physician facing federal charges of illegally prescribing opioids, and causing the overdose deaths of two South Shore men, began on Wednesday, with prosecutors calling Dr. Michael Belfiore “a dealer, not a healer,” and Belfiore’s defense attorney insisting that the doctor is being unfairly prosecuted.

Belfiore was also implicated in the 2009 death of Mario Marra, of Glen Cove. Medical records in the case were subpoenaed, although charges were not filed.

 In a series of Herald reports last summer, Marra’s widow, Claudia, alleged that Belfore continued to prescribe her late husband fentanyl and other opioids, even after he knew Marra was addicted.

Medical records indicate that Belfiore prescribed Marra fentanyl on March 7, 2009. He died on March 15, according to the coroner’s report.

Belfiore, in an interview last summer, admitted Marra was a patient, but disputed much of Claudia’s account, adding that if Marra was “responsible with the medication, and took it as directed, he’d still be here.”

Belfiore’s trial, at the U.S. District courthouse in Central Islip, is expected to last five weeks, according to his attorney, Tom Liotti, of Garden City.

After a jury was selected, Assistant U.S. Attorney Bradley King made his opening argument, describing the circumstances in which John Ubaghs, of Baldwin, and Edward Martin, of East Rockaway, were found dead — both allegedly with bottles of oxycodone prescribed to them by Belfiore.

King also introduced the government’s first witness against Belfiore: Detective James Marinucci, of the Nassau County Police Department’s vice squad. Marinucci — undercover as James Burke, a factory worker with back pain — saw Belfiore as a patient six times in 2013, obtaining six prescriptions for oxycodone. He paid in cash each time.

In a lengthy video — taken by a hidden camera Marinucci wore on a necklace — shown to jurors, the undercover detective was seen and heard during an initial appointment with Belfiore in March 2013.

During the visit, Marinucci complained of back pain, and told Belfiore that his ex-girlfriend used to share her “Oxy 30s” with him — Marinucci testified that he used this “street” phrase for the medication deliberately with Belfiore.

Belfiore agreed to write Marinucci multiple prescriptions, including for oxycodone, anti-inflammatories and Trazodone, for sleep, but did warn the undercover detective — using colorful language — about the dangers of sharing controlled substances with others.

“I’m not gonna share a jail cell with you,” Belfiore joked at one point, later stressing, “You don’t understand the stigma that’s attached to these medications now.”

Liotti was expected to cross-examine Marinucci on Thursday.

Liotti, has maintained that opioid manufacturers are the culprits in Ubaghs’s and Martin’s deaths — and in the country’s larger opioid crisis.

The defense attorney reiterated the point during his opening arguments, also calling the grand jury process that led to Belfiore’s indictment, in which he was not allowed to be present, a “one-sided proceeding.”

“We offered our own expert testimony — the government wouldn’t allow it,” Liotti said, also warning jurors that he believed the government would try to connect Belfiore’s case to the hundreds of thousands of opioid deaths nationwide.

He also challenged prosecutors to define the number of pills Belfiore could have prescribed that would have met their definition of “with a legitimate medical purpose.”

“There can be no guess-work or speculation here,” he added.

Belfiore also, Liotti said, had been honest with law enforcement throughout the yearslong case, “perhaps to a fault,” and made reference to both Arthur Miller’s “The Crucible,” and the film “12 Angry Men,” as he tried to paint Belfiore as the government’s scapegoat.

“His career and his life are on the line,” Liotti said.

Look for more coverage of Belfiore’s trial in next week’s edition, and online.

WV: Charleston family says local pharmacy gave out the wrong dose of hepatitis A vaccine

http://wvah.com/news/local/charleston-family-says-local-pharmacy-gave-out-the-wrong-dose-of-hepatitis-a-vaccine

With the increase of cases of Hepatitis-A, more people are getting vaccinated, but one Charleston family found out the vaccine they got Thursday was the wrong dose.

 A Charleston man said he was given the child dose of Hepatitis-A vaccine at the CVS pharmacy on Oakwood Road near Fort Hill. He is speaking out because he said the pharmacy never called him about this mistake. They only called one of his family members.

“As of right now, we have not received a call from CVS pharmacy,” Whitney Raines of Charleston said.

 Raines, along with his sister and brother-in law went to this CVS on Oakwood Road in Charleston to get vaccinated. He said late Thursday night his sister got a call from the pharmacist.

“She contacted my sister from her personal cell phone around 10 p.m. to tell her what had happened,” Raines said.

The CVS pharmacist told Raines’ sister that they were given the child dose of .5 ml and need to be given the other half. The adult vaccine is 1 ml. They had three days to get the rest of it. If they didn’t receive that other half the vaccine would not work. But Raine said he and his brother in law never got a call.

Raines went back to the CVS the Friday morning, but says the pharmacy manager didn’t seem concerned.

“This was a new shot and they weren’t sure what they ordered and she in turn, blamed it on CVS for ordering the wrong shots,” Raines said reciting what the Pharmacy manager told him.

Raines said he’s concerned they were not the only three impacted and feels lucky his sister was able to tell him about the mistake but says calls should be made to all the individual patients.

“I don’t know how many people have gone through there to get the vaccination but I believe the lady just called out of pure kindness and I am sure there are people that didn’t hear of it and it is very concerning,” explained Raines.

We reached out to CVS Pharmacy and spokesperson Mike DeAngelis tells us that Raines, his sister and brother in law were the only ones impacted. He adds a full investigation on how the error occurred is being conducted and that the correct procedure was followed by reaching out to the patients impacted.

Here is a full statement from CVS:

CVS Pharmacy has stringent processes that our pharmacists follow for administering immunizations. On Thursday, April 19, three adult patients who visited the Charleston CVS Pharmacy at the same time to receive Hepatitis A vaccinations were inadvertently administered the infant dose of the vaccine. As soon as our pharmacist realized this error occurred, she followed correct procedure and contacted all three patients to apologize and make arrangements for them to be re-vaccinated. These three individuals are the only patients who were administered the incorrect dose. We are conducting a full investigation into how this error occurred. CVS sincerely apologizes to the three patients and a member of our management team will be following up with each one of them.

Also, it appears there was a misunderstanding that occurred during our pharmacist’s phone call. It was not her intent to suggest that the patients couldn’t ever be vaccinated if they weren’t re-vaccinated today.

http://wvah.com/news/local/more-than-1200-alpha-kappa-alpha-sorority-members-visit-charleston

 

TN Nursing Home medication errors (wrong drug, wrong dose, wrong time) to less than 5 percent IS ACCEPTABLE ?

Nursing home ranks at bottom

https://www.t-g.com/story/2506038.html

In a September 2016 court filing, federal prosecutors said Glen Oaks Health and Rehabilitation of Shelbyville was providing “grossly substandard, and/or worthless nursing home services to Medicare and TennCare” patients.

Nearly two years later Glen Oaks is still in need of improvements.

In recently released reports rating 28 nursing homes within a 50-mile radius of Shelbyville that are ranked by the Center for Medicare and Medicaid Services, Glen Oaks Health and Rehabilitation of Shelbyville got the lowest possible ranking.

One star

Based on the survey conducted late last year, Glen Oaks was ranked with one out of five stars, a “Much Below Average” rating.

Of the 517 nursing homes that accept Medicare payments within 200 miles of Shelbyville, 13.5 percent (70) were ranked with just one star.

The most recent health inspections of area nursing homes were conducted in late November and December 2017 and the results were posted recently on the Medicare website (Nursing Home Compare).

Of the 28 nursing homes that accept payment from the Medicare/Medicaid program within 50 miles of Shelbyville four were rated with just one star.

(One of those, Manchester Healthcare Center, is owned by the same company that owns Glen Oaks.)

Six in the area were rated with two stars, “below average,” (including The Waters of Shelbyville).

Five were rated with three stars (average).

Seven area nursing homes were rated with four stars (above average) including two in Lewisburg — NHC Healthcare and NHC Healthcare Oakwood. Lynchburg Nursing Center was also rated “above average.”

Six were rated with five stars (Much Above Average) including two in Tullahoma — NHC Healthcare Tullahoma and Life Care Center of Tullahoma.

About the ratings

The rating system, developed by the Center for Medicare and Medicaid Services (CMS), ranks nursing homes in three broad categories — health inspections, staffing and “quality measures.”

Glen Oaks was rated “below average” in health inspections and “much below average” in staffing (not enough personnel). The facility was rated as average in “quality measures.”

Quality measures

Glen Oaks was rated as “Average” — three stars — in this category.

CMS determines “Quality of resident care” using 16 measures. Each of the measures is expressed in a percentage of the number of patients and is compared with rates in Tennessee and nationwide. The measures include short-term residents and long stay residents.

One common problem associated with poor care or neglect of patients is pressure ulcers, commonly called bed sores. At Glen Oaks the percentage of short term patients with bed sores that were new or worsened was four times worse than the state average — 2.5 percent as compared with the Tennessee average of 0.6 percent and the national average of 0.9 percent.

The rate of bed sores in long stay residents at Glen Oaks was much closer to the state and national averages: 6.2 percent at Glen Oaks, 5.3 percent statewide and 5.6 percent nationally.

Glen Oaks also fell short in the high percentage of long-stay residents whose ability to move independently got worse. Glen Oaks: 34.3 percent got worse; Tennessee: 21.4 percent got worse; and nationally 18.2 percent got worse.

Glen Oaks did do better in some quality measure areas including the number of patients who got flu shots, a low percentage of patients who lost too much weight, low percentage of patients who suffered major injury from falls and low percentage of long term patients who had symptoms of depression.

Staffing

It was in “Staffing” that Glen Oaks did most poorly with only one star — “much below average.”

CMS says of this category: “Higher staffing levels in a nursing home may mean higher quality of care for residents. This section provides information about the different types of nursing home staff and the average amount of time per resident that they spend providing care.”

At Glen Oaks the total amount of time a Registered Nurse is available per resident, per day is 26 minutes, half that of the national average. Tennessee’s average is 46 minutes a day and the national average is 50 minutes. The availability of physical therapy staff at Glen Oaks was also lacking: 3 minutes as compared with the state and national averages of 6 minutes.

Health Inspections

Glen Oaks was ranked “below average” (two stars) in this category.

Glen Oaks was cited for eight violations, as compared with the Tennessee average of four and the national average of 5.8.

In the most recent available “statement of deficiencies and plan of correction” from a July 2017 inspection.

According to the report:

* Glen Oaks failed to immediately report allegations that a resident had been abused. The incident was not reported until seven days later. CMS requires that such allegations be reported within 24 hours.

*Glen Oaks failed to adopt an abuse policy that met CMS requirements.

*Glen Oaks failed to provide care that protects its residents’ dignity.

*Glen Oaks failed to provide proper housekeeping services. This finding was the result of a wheel chair coated with a “heavy accumulation of dried debris”. Wheel chairs are supposed to be cleaned daily.

*Glen Oaks staff failed to properly secure medications, and failed to keep the rate of medication errors (wrong drug, wrong dose, wrong time) to less than 5 percent.

One example of this, was that a prescription medication that was supposed to have been stopped on June 9 was still being given to the patient on July 11.

*Glen Oaks staff failed to properly secure prescription medications. A prescription medication with no pharmacy label or any label indicating patient information was found unopened on a resident’s bedside table.

• Glen Oaks failed to follow infection control practices in dispensing medications to eight patients. The facility’s workers failed to “wash/sanitize hands between residents for two residents, failed “to prepare medications in a safe manner for two residents,” failed “to dispose of unused medications appropriately for one resident,” and failed to “protect respiratory equipment from contamination for seven residents.”

In summary

In a summary of all health inspection deficiencies in recent years, Glen Oaks was cited eight times in the period from March 2017 to March 2018; three times from March 2016 to March 2018 and six times from March 2015 to March 2016.

Fire safety inspection

In July 2017, fire inspectors identified six “smoke deficiencies,” reporting that Glen Oaks did not:

• have walls in “special areas” constructed so that they can resist fire for one hour or more or have an approved fire extinguishing system,

• have a fire alarm that can be heard throughout the facility,

• Inspect, test, and maintain automatic sprinkler systems,

• Properly select, install, inspect or maintain portable fire extinguishers, and

• Ensure smoke barriers are constructed to provide one hour fire resistance.

Glen Oaks corrected all the fire safety issues 44 days after the inspection.

Not first problem for owners

Glen Oaks has been owned by Vanguard Healthcare LLC since July 2007. The company has been in litigation with the federal government since 2016 accused of filing false claims. (See related story.)

• Vanguard healthcare CEO William “Bill” Orand did not return phone calls seeking comment. Glen Oaks administrator Cassandra Callahan also did not return phone calls seeking comment.

WV AG: suing the DEA because the national drug quota system had utterly failed our citizens

West Virginians weigh opioid response as they look at GOP Senate candidates

http://www.foxnews.com/politics/2018/04/20/west-virginians-weigh-opioid-response-as-look-at-gop-senate-candidates.html

Republican candidates running in the Mountain State’s Senate primary have spent time in court, in Congress and in a correctional facility.

Each has different ideas about how to fix the opioid epidemic, and voters are carefully weighing those ideas, less than three weeks until the election that will decide who gets to challenge Sen. Joe Manchin, a Democrat.

West Virginia Attorney General Patrick Morrisey is taking credit for a court victory that inspired a freshly proposed Drug Enforcement Administration (DEA)  rule that could cut down on opioid production.

“We’ve been tackling the problem about as aggressively as any office can,” Morrisey said. “Part of the reason why we sued the DEA is that we found out the national drug quota system had utterly failed our citizens, they were rubber-stamping ever increasing amounts of pills flooding into our state and across the country.”

West Virginia has the highest rate of drug overdose deaths in the country, and those fatalities are driven by opioids, according statistics kept by the Centers for Disease Control and Prevention.

Congressman Evan Jenkins (R-W.Va.) is the only candidate in the GOP primary field now serving in D.C., and since Congress cuts checks meant for opioid education and treatment, he believes he’s best positioned to continue the fight as senator.

“We’re walking the walk,” Jenkins said. “I have served on the appropriations committee, the $6 billion working with the white house that we’ve just approved is a significant, positive step in the right direction.”

Jenkins also helped establish Lily’s Place in Huntington, a neonatal abstinence syndrome center that was visited by First Lady Melania Trump last year.

President Trump won West Virginia by 42 points in 2016, and an outsider candidate with a business background is now pitching himself as the best to address the state’s opioid crisis – with a broad pitch that sounds a lot like the one candidate Trump brought to coal country.

“The wall is very important,” Don Blankenship said. “Ending the sanctuary cities is important, drug testing public officials – particularly teachers and judges and prosecutors, is important, and basically getting after the doctors and keeping better measurement of who is prescribing the drugs and who is distributing them.”

Blankenship recently served a one-year prison term following a conviction to skirt mine safety regulations, tied to his role as the former chief executive of Massey Energy, when the Upper Big Branch mine disaster occurred and killed 29 people.

The former coal baron is now trying to get his conviction, which he insists is not a liability, overturned.

And with regard to the opioid epidemic, Blankenship believes he’s the only one running whose hands are clean from the crisis.

“I think both of them are greatly responsible for the epidemic,” Blankenship said about his opponents Jenkins and Morrisey, “because they haven’t done enough.”

Will PBMs Be the Next Target of Opioid Lawsuits?

http://managedhealthcareexecutive.modernmedicine.com/managed-healthcare-executive/news/will-pbms-be-next-target-opioid-lawsuits

Although suing physicians and pharmacists over the opioid crisis is nothing new, up until now pharmacy benefit managers (PBMs) have been off the radar screen. But in February, a south Texas county included the three largest PBMs—CVS, Express Scripts, and OptumRx as well as some smaller ones operating in Texas—in a nationwide lawsuit focusing on the opioid epidemic because of their role in allowing access to prescription opioids.

PBMs set the rules that determine drug availability and how much patients have to pay out of pocket to get them. So why haven’t they been targeted until now?

NelsonNelson

Harry Nelson, managing partner, Nelson Hardiman, LLP, a healthcare law firm, says physicians have been targeted based on their role as prescribers and as frontline decision makers with the capability to avoid opioid overprescribing, dependency, and resulting harm. Similarly, pharmacists have been sued because of their roles as dispensers and their capacity to serve as the last safeguard before patients end up at risk from overprescribing.

“While PBMs play a critical role in drug’s pricing and availability, they are not expected to question physician’s therapeutic choices,” Nelson says. “They don’t have the same professional obligations that pharmacists do to avoid suboptimal dispensing choices. As unlicensed entities, they don’t hold individual licenses, as physicians and pharmacists do, so they are not held to the same standard. Their roles and responsibilities are less well-defined, so there is less basis to hold them responsible.”

 

 

 

Metzler

 

 

Metzler

Nonetheless, PBMs actually have a lot of power, says Christopher J. Metzler, PhD, JD, CEO, Gordium Healthcare, a multidisciplinary behavioral healthcare organization. They are the middlemen who operate between the doctor, patient, and pharmacy. They provide insurance contracts with pharmacies and can deny a claim’s payment. They have the most to gain from a prescription’s cost.

Given the number of governmental entities now bringing lawsuits, and the limited number of manufacturer and distributor targets, Lawrence Ingram, a partner in the law firm Freeborn & Peters’ Litigation Practice Group, and a member of its Insurance and Reinsurance Industry Team, foresees every entity in the distribution chain eventually getting caught up in this type of litigation. 

IngramIngram

Similar lawsuits likely

In the Texas case, The Webb County lawsuit alleged that PBMs drove the opioid epidemic as a result of increasing profits from the drugs.

Nelson says since it doesn’t cost much to name a PBM as an additional party in litigation, he expects PBMs to increasingly be named in opioid-related lawsuits. “While it takes some creativity to do something new (like looking at PBMs) as a responsible party, my hunch is that other lawyers are likely to learn from this and will be interested in a potential additional source of settlement funds,” he says.

Metzler also expects more PBMs to be sued. “Lawyers who present a well-written and brutal set of discovery questions, review the prescription paper trail, and talk to pharmacies and patients will find a treasure trove of evidence to present to a jury,” he says.

So on what grounds could PBMs be sued? Nelson says PBMs may not hold licenses that impose obligations, but their contractual commitments as intermediaries between health plans and pharmacies provide a potential argument that they also owe responsibility to patients, who are arguably third-party beneficiaries of those contracts. In other words, health plans are contracting with PBMs for the benefit of patients, so PBMs have the responsibility to protect patients from harm. There may also be an argument that PBMs are in a better position than individual pharmacies because of their data access to red flag problematic prescribing practices.

Ingram says allegations would likely be that the PBMs somehow allowed a greater amount of these drug products to be permitted in communities than could be supported by legitimate medical needs.

Likely outcomes

As a novel legal theory, lawyers will have to explain in detail to the courts what PBMs are and how they operate. “Unless lawyers are able to do so and prove causation, this will be a very difficult road to travel,” Metzler says. “As in most novel legal theories, this is a test, the outcome of which is uncertain. It is up to lawyers to educate, persuade, and prove causation.”

In the future, Nelson says PBMs may put additional safeguards in place to scrutinize troubling practices that surface through data, such as potential indicia of excessive prescribing. For patients, getting access to opioids is likely to get even tougher, with another hurdle in the form of PBMs. This may also make opioids more expensive, as PBMs begin to factor in the additional costs and risks associated with opioid prescribing.