http://pittsburgh.legalexaminer.com/fda-prescription-drugs/indiana-couple-wins-first-xarelto-trial-in-philadelphia/

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I found out today it’s is the MS Bureau of Narcotics that are pressuring the doctors in this state to cut back. In TX they did the same thing and the doctors filed a class action suit against the narcotics bureau for practicing medicine without a license and the doctors won. After Christmas I’m going to attempt to file a criminal charge against the director of MBN. The doctors here are to scared to do it. I’ve also spoken to the DEA. They are trying to shut down the pill mills but they are NOT interfering with doctors prescribing for real causes like my nerve damage. I’m medically retired Law Enforcement. I don’t mind stirring up a stink when they start messing with my quality of life. Check in your state. Most states have similar laws.The MBN does not have a medical doctor on staff.

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My father who was also a physician took his own life because of trigeminal neuralgia. Four days ago a long term friend and former and a former patient of mine shot himself in the head when he was forced by the medical board to taper off the opioids that were keeping him comfortable enough to work productively.

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The “excuse” … “I’m not comfortable” infers that the Pharmacist has made a decision… based on certain FACTS that would make the prescription not medically appropriate for a particular pt.  Level one interaction with the pt’s other medications, allergy, dose too high or too low.. having checked a PMP report the pt appears to be a doc/pharmacy shopper…

The “excuse” ….”I don’t have inventory” .. is a fact that supposedly doesn’t have anything associated with a professional medical decision.  I suspect that most pharmacists believe that in saying that.. there is no way for the pt to prove that the pharmacy has – or has not – any inventory.

I was at a meeting of the FL board of Pharmacy in June of 2015 when they were discussing a new regulation about how Pharmacists in FL are suppose to NOT start looking for reason to refuse to fill a controlled prescription.  It went into effect the end of Dec 2015.  At that meeting a chronic pain doctor asked the attorney for the board if a pharmacist lying to a pt about having inventory was UNPROFESSIONAL CONDUCT…. and basically the response from the Board’s attorney was “.. there is nothing in the practice act that addresses that … so NO …”

After all the DEA cut opiate production quotas by up to 25% in 2017 and proposed another 20% cut in 2018.  The largest pharmacy wholesaler ( McKesson) had the DEA try to build a case against them for not properly controlling the distribution of opiates and prepared to hit them with a ONE BILLION DOLLAR FINE… but apparently McKesson hired the baddest ass attorney firm in the country and the DEA attorneys became unsure of their “slap dunk case” against McKesson and every settle with McKesson paying a few million in fines..  But there were two other major pharmacy wholesalers which the DEA  was probably going after next after they “took down Mc Kesson”… remember the DEA’s budget is TWO BILLION… so a BILLION more from McKesson would have allowed them to do what ?

So, I would expect that the pharmacy wholesalers are going to “tighten down” on what they will allow any particular pharmacy to purchase.

So what is a pt to do?… get use to the “pharmacy crawl” ?

Most pt don’t know that each pharmacy is required to keep a PERPETUAL INVENTORY on all C-II…  They should be able to go to their perpetual inventory book and know exactly what is on hand at any moment. Each prescription filled is entered into this record by date and maybe by the time the label of the prescription was printed… also they have to enter into this perpetual inventory any increase in inventory when they receive it from their supplier.

The pt should at the very least have someone go with them to witness that the reason that your prescription was not filled was because it was stated that they had no inventory… at least take a picture of the Rx dept staff that told you “NO INVENTORY” or if legal.. video the transaction.

The only option that the pt has at this point is to hire an attorney to ask the courts to subpoena the pharmacy’s inventory records for the particular day and the particular medication to validate that there was no inventory on hand… when you presented a prescription to be filled.

Proving that there was medication on hand… and chronic pain pt or any pt suffering from a subjective disease should be considered disabled and discriminating against a person covered by the Americans with Disability Act and/or Civil Rights Act… that discrimination is considered a CIVIL RIGHTS VIOLATION.

Once a pt has proven that they have been lied to and discriminated against… the Pharmacist and maybe their employer no longer has the UPPER HAND !

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An Invitation from Art Levine, reporter for Newsweek and other major media outlets:

Art Levine is a freelance journalist who has written for Newsweek on the deadly, damaging effects of the crackdown on legal opioid prescribing to chronic pain patients. See  http://www.newsweek.com/va-opiod-policy-wreaks-havoc-former-marine-683467 and https://www.alternet.org/drugs/pundits-focused-trump-craziness-ignoring-threat-mentally-ill-addicts

Art hopes to interview surviving family members or friends of chronic pain patients who have committed suicide, since 2016 and the CDC guidelines — and who had no history of major mental illnesses prior to developing their chronic pain.

Art can be reached via twitter @ArtL7, or facebook PM messaging and https://www.facebook.com/ArtLDC. He is interested in interviewing one or two more chronic pain patients concerning your personal knowledge, of cases where you or other patients who have no histories of addiction or drug abuse, are being denied opioids or have been discharged by their doctors. He also looking for a few examples of doctors who haven’t yet been arrested,  aren’t being subsidized  by drug companies or hadn’t had their licenses revoked but are still being harassed or otherwise threatened by enforcement /regulatory agencies because they’re prescribing opioids to chronic or acute pain or cancer patients. (He can’t use the Dr. Tennant case, for instance, because of Dr. Tennant’s ties to the controversial Insys company facing criminal indictment http://www.cnn.com/2017/09/06/politics/insys-cancer-drug-company-faked-cancer-patients-to-sell-drug/index.html, which doesn’t make him credible to his editors.)

He is  also looking for people with policy knowledge about specific regulatory, legal, DEA developments in such states as Indiana and Maine.

I (RICHARD LAWHERN/Steve Ariens) will be available to hear about your experiences with Mr. Levine during interviews. I have cautioned him that he will be dealing with people who have already been traumatized by pain or deep emotional loss. He has promised to interview thoughtfully and to represent your stories without distortion when he publishes.

Regards all,
Red Lawhern/ Steve Ariens

Art Levine 202-248-9320 / cell phone: 202-557-8443 Please reply directly to this Yahoo mail address but also please  CC: to my gmail account, artslevine@gmail.com, due to occasional Yahoo mail glitches.

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Women attend a candlelight vigil during the FED UP! Coalition’s annual International Overdose Awareness Day event in Washington in August. A new CDC report ESTIMATES 63,600 people died of drug overdoses in 2016.

What good is the CDC, if all they can do is ESTIMATE STATS ?

www.statnews.com/2017/12/21/life-expectancy-drug-overdose

Life expectancy in the U.S. has fallen for the second year in a row, the first time it’s dropped for two consecutive years in more than half a century.

People born in the U.S. in 2016 could expect to live 78.6 years on average, down from 78.7 the year before, according to a new report released Thursday by the Centers for Disease Control and Prevention. The most common cause of death: heart disease.

The report also found death rates — calculated from the number of deaths per 100,000 people — actually rose among young adults between 2015 and 2016. And while the authors didn’t draw a direct link, another report also released Thursday by the CDC found an estimated 63,600 people died of drug overdoses in 2016. Two-thirds of those deaths were caused by opioids. Adults between the ages of 25 and 54 had the highest rate of drug overdose death.

Here’s a look at the findings:

Most common causes of death

Heart disease was the leading cause of death, followed by cancer, unintentional injuries, chronic lower respiratory diseases, stroke, Alzheimer’s disease, diabetes, influenza and pneumonia, kidney disease, and suicide.

One key point: Unintentional injuries climbed to the third leading cause of death in 2016, swapping spots with chronic lower respiratory diseases. It’s worth noting that most drug overdose deaths are classified as unintentional injuries.

AS IF… NO ONE would use drugs – including ALCOHOL to commit SUICIDE ?

Black men are dying at alarmingly high rates

Life expectancy isn’t falling for women — just for men. Life expectancy for women at birth is 81.1 years, compared to 76.1 years for men.

The death rate for the general population actually declined slightly in 2016, but that drop wasn’t seen across all racial and ethnic groups. Death rates among black men climbed 1 percent in 2016, while death rates among white women actually fell 1 percent. There weren’t any big changes in death rates among black women, white men, or Hispanic men or women.

Drug overdose deaths continue to climb

Drug death rates are increasing much faster than they have in recent years. Overdose death rates climbed roughly 10 percent per year between 1999 and 2006. Then there was a relative lull: Between 2006 and 2014, they increased roughly 3 percent each year.

But from 2014 to 2016, death rates tied to drug overdoses jumped 18 percent each year.

Deaths due to synthetic opioids are rising

The rate of overdose deaths involving synthetic opioids other than methadone — a category that includes fentanyl, fentanyl analogs, and tramadol — doubled between 2015 and 2016. The rate of drug overdose deaths involving natural and semisynthetic opioids, such as oxycodone and hydrocodone, also rose, while overdoses involving methadone declined.

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http://www.clarionledger.com/story/news/politics/2017/12/15/medical-regulator-assures-opioid-rule-changes-dont-throw-patients-wolves/955257001/

Susan Norton of Brookhaven attended the Mississippi State Board of Medical Licensure meeting Friday, actively withdrawing from morphine.

Norton, who has been diagnosed with a chronic, painful bladder disease called Interstitial cystitis, was discharged from her pain management specialist in November, just as the state’s medical regulatory agency started mulling increased opioid prescription rules.

“I just feel like the state of Mississippi has thrown me to the wolves and literally to the street to figure this out on my own, and I don’t want to die. But there’s no where to land,” Norton said, just after

board members said their rule changes would not prohibit all opioid use for chronic pain.

“What I’m hearing today is not what’s happening out there with patients like me who have legitimate pain and need something … The doctors are scared.”

Board members assured Norton their

proposed opioid prescription rule changes do not prevent a doctor from prescribing opioids to treat the pain associated with her condition

but that they would require doctors to complete additional documentation. 

“If asking someone to jump through a few extra hoops prevents a physician from doing that … shame on them,” said board member Dr. Randy Easterling.

Norton had been on 60 milligrams of morphine and 12 milligrams of Dilaudid for 10 years but she’s been cut off the last five weeks, causing her to experience withdrawals. She said she can see her heart beating through her chest sometimes. 

“It’s where you just lay on the cold bathroom floor just to feel something other than pain,” Norton said.

Norton was near finishing nursing school 20 years ago when she was diagnosed with the bladder disease, which changed her life. Opioid users are sometimes labeled “drug seekers,” Norton noted, but she’s tried other pain management techniques with little success.

In an open work session Friday, the medical licensure board finalized and unanimously passed proposed opioid prescription rule changes, tweaked slightly since its last hearing and pending additional review.

The regulations limit opioid prescriptions to seven days for acute pain, prohibit opioids for chronic pain except where doctors can document it’s the only viable option and require doctors to check the Prescription Monitoring Program and deliver drug tests to patients before writing opioid prescriptions. 

The rules do not apply to terminal and cancer pain patients or opioid use in an inpatient setting. The changes are aimed at ramping up prescription monitoring and

discouraging doctors from prescribing opioids

amid an epidemic that kills nearly 100 Americans a day.

“It’s scary,” Norton said of not having access to her medication. “I just feel like I just got thrown out because it was too much for the doctors to want to have to deal with it.”

“Unfortunately, all the doctors won’t read this …

We’re not stopping opioids. We’re not doing anything like that. We’re just for the responsible use

” said board president Dr. Charles Miles, who cites medical literature about the ineffectiveness of opioids for the management of long-term pain. “You can take opioids to the point that the opioid itself causes the pain. It’s ‘opioid hyperalgesia’ and you don’t know that until you start backing off the opioids. then the pain gets better.”

Board members didn’t agree on everything in the nearly three-hour meeting Friday, during which they negotiated mostly specific, technical changes to the language of the new rules.

Board member Dr. Ken Lippincott, a psychiatrist, raised concerns over patient drug testing requirements in psychiatric offices when the patient is being prescribed benzodiazepines, like Valium or Xanax. Some smaller clinics might not have the facilities to do drug testing and, more concerning, it could damage trust between the physician and patient, Lippincott said.

Board member Dr. Claude Brunson, a University of Mississippi Medical Center physician, called for the board to vote whether to exempt psychiatrists from the new rule, saying it may do more harm than intended good.

“If that’s going to deter folks from getting mental help that they need, that’s a public issue,” Brunson said.

The motion failed.

The new rules will go to the Occupational Licensing Review Commission, which the Legislature created during the 2017 session to reign in regulatory boards, for final approval. First, the proposed changes must be filed with the secretary of state’s office to allow for public comment.

Apparently these board members do not listen to what they say or what is put in the proposed regulations.. They are not going to prohibit opiates being prescribed for chronic pain.. BUT.. the prescribers are going to be presented with a whole lot of time consuming administrative tasks in order to do so.. with apparently NO GUARANTEE that in doing so would indemnify the prescriber from being “drug thru the mud” for doing so ?

RULE CHANGES are always subject to interpretation and all too often the interpretation of the rule that is enforced may not meet the letter and intent of the rule.

Just look at what the DEA has done over the last 47 yrs with interpretations of the Controlled Substance Act 1970 and they have generated some NEW INTERPRETATIONS of that law in the last yr +.

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In 2009, prescription narcotics were involved in 26% of all fatal drug overdoses, while heroin was involved in 9% and synthetics were involved in just 8%. By comparison, in 2016, prescription drugs were involved in 23% of all deadly overdoses. But heroin is now implicated in about a quarter of all drug fatalities, and synthetic opioids play a role in nearly a third.

These increases have contributed to a shortening of the US life expectancy for a second year in a row.

A state-by-state look

The states with the highest rates of overdose in 2016 were West Virginia, Ohio and New Hampshire, the report said. The rate of overdose in West Virginia was over 2.5 times the national average of 19.8 overdose deaths for every 100,000 people.

While the outlook nationwide is fairly bleak, it’s particularly bad in some states. Twenty-two states and the District of Columbia had overdose rates significantly higher than the national average.

While overdose rates increased in all age groups, rises were most significant in those between the ages of 25 and 54.

 

Overall teen drug use stable, but marijuana edging up, survey finds

Provisional data for 2017 from the CDC show no signs of the epidemic abating, with an estimate of more than 66,000 overdose deaths for the year. “Based on what we’re seeing, it doesn’t look like it’s getting any better,” said Bob Anderson, chief of the mortality statistics branch at the National Center for Health Statistics.

He said the data for this year were still incomplete because of the time it takes to conduct death and toxicology investigations. However, Anderson says, the 2017 estimates are alarming. “The fact that the data is incomplete and they represent an increase is concerning,” he said.

But addiction specialist Dr. Andrew Kolodny said that despite the devastating overdose numbers, there appeared to be some indicators of good news.

 

Cocaine deaths among blacks on par with opioid deaths among whites, study finds

“Even though deaths are going up among people who are addicted heroin users, who use black-market opioids … it’s possible that we are preventing less people from becoming addicted through better prescribing,” said Kolodny, executive director of Physicians for Responsible Opioid Prescribing.

Studies have shown that while rates of opioid prescribing remain high in the US, they have decreased from a peak of 81 prescriptions for every 100 people in 2010 to about 70 per 100. Kolodny also pointed to recent surveys indicating that opioids were being less-frequently abused by teens.

A public health emergency

In October, President Trump declared the opioid crisis a public health emergency. “As Americans, we cannot allow this to continue. It is time to liberate our communities from this scourge of drug addiction,” he said. “We can be the generation that ends the opioid epidemic.”

The week following, the President’s Commission on Combating Drug Addiction issued its final report with more than 50 recommendations to help solve the opioid crisis, including expanding medicated assisted treatment, increasing the number of drug courts, coordinating electronic health records and increasing prescriber education.

 

Opioid crisis: Childhood friends die on same day, half a mile apart

However, Kolodny and other public health experts were disappointed that the actions by the president and the commission were not accompanied by funds.

“You don’t call it an emergency and sit around do nothing about it — and that’s where we are,” Kolodny said. “The doing something should be a plan from the agencies … and it should be seeking money from Congress.”

Commission member and former Rep. Patrick Kennedy agreed. “It means nothing if it has no funding to push it forward. You can’t just have a speech like the President gave.”

But fellow commission member Bertha Madras said that funding requests can’t be immediately answered and pointed out that the White House is working with agencies now to determine costs and processes to implement the group’s recommendations. “The commitment has to be accompanied by wise decisions and wise planning and a very judicious use of funding,” she said.

The White House’s Council of Economic Advisers recently estimated that the cost of the opioid crisis in 2015 alone was $504 billion, nearly 3% of gross domestic product.

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Kennedy worries that the tax bill passed this week will only worsen the crisis. “It’s going to be the vote that sets this country back further than anything else in our ability to tackle this crisis. Period. There’s going to be no more significant vote on opioids.”

The bill, which is now headed to the President’s desk to be signed into law, eliminates provisions of the individual mandate or penalties for being uninsured that were required under Obamacare. Once it is enacted, the nonpartisan Congressional Budge Office estimates, 13 million individuals will be uninsured by 2027, and health insurance premiums will go up. According to the 2016 Surgeon General’s Report on Alcohol, Drugs, and Health, 30% of Americans do not seek any sort of addiction treatment because they do not have insurance and cannot afford treatment.

“We’ve got a human addiction tsunami. We need all hands on deck,” Kennedy said

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https://www.forbes.com/sites/matthewherper/2017/12/19/here-you-can-watch-every-second-of-the-forbes-healthcare-summit/#6cb458625720

A lot of the best moments at the Forbes Healthcare Summit, which was held November 29 and November 30 in New York, happened on the sidelines. You can’t witness those unless you’re there. But you can see every moment that happened on-stage, even if you weren’t there. Below is a link to video of every single panel, spotlight session, and interview.

Nighttime: The Diagnosis

Using Big Data To Find The Best Doctors My opening statement, and an interview with Owen Tripp, co-founder & chief executive officer, Grand Rounds, about two lists his company created ranking cardiologists and breast oncologists.

Stopping Cancer With Cells. Leukemia & Lymphoma Society president Louis J. DeGennaro interviews Austin Schuetz, 11, who was saved by CAR-T therapy, and his parents, Kimberly and Jeffrey.

Johnny Wolf

LLS Chief Executive Louis J. DeGennaro, interviews Austin, Kimberly & Jeffrey Schuetz

An Interview With Novartis’ Next CEO Incoming chief executive Vas Narasimhan talks with me about the future of CAR-T cells and what’s coming next for the Swiss drug giant.

The Billionaire Behind The World’s Largest Drugstore Chain Forbes Media EVP Moira Forbes interviews Stefano Pessina about the creation of Walgreens Boots Alliance, a bet on scale and volume. What does he foresee for the future of healthcare?

Morning: Treatment

Five Fixes for Healthcare

In a session moderated by Forbes Executive Editor Michael Noer, we asked five visionaries what they would do to improve U.S. healthcare if they had a magic wand. Here’s what each proposed:

• The Government Should Buy Gilead Sciences Peter B. Bach,  MAPP, Director, Center for Health Policy and Outcomes, Memorial Sloan Kettering Cancer Center
• Tax Pharma To Pay For The NIH Laurie H. Glimcher, Chief Executive Officer, Dana-Farber Cancer Institute
• How Smartphones Will Transform Healthcare Diane P. Holder, President & Chief Executive Officer, UPMC Health Plan
• Healthcare Is About Buildings & Food Barry H. Ostrowsky, President & Chief Executive Officer, RWJBarnabas Health
• Make Scientists The Real Celebrities  George D. Yancopoulos, President & Chief Scientific Officer, Regeneron
• Discussion And Audience Q&A

An Interview With CMS Administrator Seema Verma Avik Roy, President of The Foundation for Research on Equal Opportunity and Opinion Editor, Forbes Media, checks in with Verma, who lays out her agenda for Medicare and Medicaid.

Johnny Wolf

CMS Administrator Seema Verma at The Forbes Healthcare Summit

What The Heck Does ‘Value’ Mean? Everybody is using the word. Do we all mean the same thing? Forbes Media Chairman & Editor-in-Chief Steve Forbes directs a discussion with: Patrick Conway, President & Chief Executive Officer-Elect, Blue Cross and Blue Shield of North Carolina; Mark Jarrett, Chief Quality Officer, Northwell Health; Steve Nelson, Chief Executive Officer, UnitedHealthcare; and Richard Rothman Founder, The Rothman Institute, Thomas Jefferson University Hospital.

Spotlight: Treating My Own Disease After he was diagnosed with a deadly disease, David Fajgenbaum, Assistant Professor of Medicine, University of  Pennsylvania and Co-Founder & Executive Director, Castleman Disease Collaborative Network, and Forbes 30 Under 30 Alum.

Dissecting The Drug Dollar What happens to drugs before you buy them, and what does it cost?  Avik Roy leads a discussion with John Maraganore, Chief Executive Officer, Alnylam,  Stephen Ubl, President & Chief Executive Officer, Pharmaceutical Research & Manufacturers of America, and Tim Wentworth, President & Chief Executive Officer, Express Scripts.

From High School Dean To Heroin Addict To Licensed Professional Counselor Nicholas deSpoelberch, Licensed Professional Counselor in Recovery, tells his story.

The Opioid Epidemic: Solutions The widespread availability — and heavy marketing — of sustained release opioid pills created a national crisis. In 2016, some 50,000 Americans died of opioid overdoses. How do we close this Pandora’s box? I lead a discussion with: Troyen A. Brennan, MD, MPH, Executive Vice President & Chief Medical Officer, CVS Health; Wilson M. Compton, MD, MPE, Deputy Director, National Institute on Drug Abuse; Thomas R. Frieden, MD, MPH, President & Chief Executive Officer, Resolve to Save Lives; Patrice A. Harris, MD, MA, Immediate Past Chair, Board of Trustees, American Medical Association, and Andrew Kolodny, MD, Co-Director of The Opioid Policy Research Collaborative, The Heller School for Social Policy and Management.

Johnny Wolf

Luhan Yang talks about transplanting pig organs into people at the Forbes Healthcare Summit.

Spotlight: Transplanting Pig Organs Into People Luhan Yang, PhD, Co-Founder & Chief Scientific Officer, eGenesis; Forbes 30 Under 30 Alum

Transformations Moira Forbes interviews Martine Rothblatt, Chairman & Chief Executive Officer, United Therapeutics, who helped create satellite radio and founded a biotech company to help sick kids who suffered from the same illness as her child. What’s next? Pig-to-human organ transplants. Robotics. Regenerative Medicine.

Afternoon: Prevention

Hacking Your Health Driven by big companies with big-time health spending, Silicon Valley is using machine learning to transform public health. Moderated by Josh Wolfe, Co-Founder & Managing Partner, Lux Capital:

• Your Genes: Tony Wang, Chief Operating Officer, Color
• Your Pancreas: Sami Inkinen, Founder & Chief Executive Officer, Virta Health
• Aging: Seth Sternberg, Co-Founder & Chief Executive Officer, Honor
• Your Bill: Rajaie Batniji, Co-Founder & Chief Health Officer, Collective Health

Machine Medicine I lead a discussion on how computers will change healthcare with: Jim Breyer, Founder & Chief Executive Officer, Breyer Capital; Carsten Brunn, Head of Pharmaceuticals, Americas Region, Bayer; Jonathan Bush, Co-Founder and Chief Executive Officer, athenahealth; August Calhoun, PhD, Senior Vice President, North America Services, Siemens Healthineers;

and Colin Hill, Co-Founder, Chairman & Chief Executive Officer, GNS Healthcare.

The Promise Of Gene Editing Leukemia & Lymphoma Society CEO Louis J. DeGennaro talks about cutting edge CAR-T therapy with Emily Dumler, who was saved by it.

Gene Therapy Comes Of Age Until now, the idea of editing genes to cure disease was just a dream. Meg Tirrell of CNBC leads a discussion on the new reality with Arie Belldegrun, MD, FACS, Founder, Kite Pharma, Nick Leschly, chief executive officer, bluebird bio, and Jeffrey D. Marrazzo, Co-Founder & Chief Executive Officer, Spark Therapeutics

Johnny Wolf

Discussing machine learning in healthcare, from rom left to right: Matthew Herper, Forbes; Jim Breyer, Breyer Capital; Carsten Brunn Bayer; Jonathan Bush, athenahealth August Calhoun, Siemens Healthineers; and Colin Hill, GNS Healthcare.

Spotlight: An Ultrasound in Your Pocket  Nevada Sanchez, Co-Founder, Butterfly Network, and Forbes 30 Under 30 Alum shows off a neat new imaging device.

The Pharma All-Stars The drug industry’s ability to innovate — and its ability to charge high prices — are at the center of the healthcare debate, whether they like it or not. I moderate a discussion including: Kenneth C. Frazier, Chairman of the Board & Chief Executive Officer, Merck & Co.; Ian Read, Chairman & Chief Executive Officer, Pfizer; David A. Ricks, Chairman & Chief Executive Officer, Eli Lilly & Company; Brenton L. Saunders, Chairman, President & Chief Executive Officer, Allergan; and Leonard Schleifer, MD, PhD, President & Chief Executive Officer, Regeneron.

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Independent Pharmacy Says Giant Insurer Shuts It Out

www.courthousenews.com/independent-pharmacy-says-giant-insurer-shuts-it-out/

HOUSTON (CN) – A pharmacy owner claims the nation’s largest health insurer, UnitedHealth Group, is trying to squeeze it out of the $100 billion specialty drug business, according to an antitrust lawsuit filed in federal court.

Lead plaintiff Cedra Pharmacy Houston LLC accuses UnitedHealth Group of blocking its new pharmacies in Texas and California, effectively cutting it out of handling claims for the group’s 65 million insured.

The market for specialty drugs–high-cost medications that treat chronic conditions like hepatitis C, HIV, multiple sclerosis, rheumatoid arthritis, and hemophilia–is expected to jump from $100 billion to $400 billion by 2020, according to the complaint.

Cedra says it started its business with a specialty pharmacy in the Bronx in 2013, then opened two more in Manhattan before getting licenses to sell drugs in 30 states and earning accreditation from two organizations with such high standards that they have only accredited a total of 63 pharmacies out of thousands in New York state.

According to Cedra, the biggest markets for prescription drugs in the United States are New York, Texas and California, and shortly after opening its Bronx pharmacy it started a brisk business filling orders by mail for Texas clients.

“By 2015, Cedra Bronx was doing over $20 million in business filling prescriptions for various specialty drugs in Texas,” Monday’s lawsuit states.

Cedra says it found success despite a system that’s stacked against independent pharmacy owners, in which pharmacy benefit managers affiliated with, or owned by, major health insurers like UnitedHealth Group own large in-house mail-order specialty pharmacies.

According to the 53-page lawsuit, most health insurers contract exclusively with one pharmacy benefit manager (PBM) to handle all their members’ prescription claims.

“To be able to service patients who have a particular health insurance plan, a pharmacy must enter into an agreement with a specific PBM to participate in its network,” the lawsuit states.

Cedra says that UnitedHealth Group-owned pharmacy benefit manager Catamaran/ORX is one of three PBMs, along with CVS Caremark and Express Scripts, that control most of the prescription drug market.

According to the lawsuit, Catamaran/ORX accounts for 22 percent of all prescription claims nationwide.

Because of this, Cedra says independent pharmacy owners cannot survive without access to its network of patients.

Cedra adds that the 2015 Catamaran/ORX merger also combined two large specialty pharmacy companies, Salveo and BriovaRX, bringing them all under UnitedHealth Care Group, and creating an unfair advantage.  Because they have better access to patients’ data and claims records than independent pharmacists, they can more effectively solicit patients and their doctors for specialty pharmacy business, Cedra says.

Cedra claims OptumRX changed its rules in the spring of 2015 while in merger talks with Catamaran, blocking Cedra from shipping orders to Texas from New York. So Cedra opened two pharmacies in Texas–one in Houston and one in Dallas.

It recently opened a pharmacy in Los Angeles as well and filed applications for all three with Catamaran/ORX for access to patients in its network.

Cedra says despite federal and state laws in California and Texas that obligate Catamaran/ORX to admit any pharmacy “ready and willing to meet the same standards and conditions as other network pharmacies,” Catamaran/ORX denied its Houston pharmacy’s enrollment application in June 2016, then denied its Dallas pharmacy in January of this year.

According to Cedra, Catamaran/ORX is stalling on the network-enrollment application it filed for its Los Angeles pharmacy in June.

“For six months, ORX simply refused to act upon Cedra LA’s application or provide any notice of the reasons for what amounted to an effective denial,” the lawsuit states.

Cedra accuses Catamaran/ORX of basing the network-access denial for its Houston pharmacy on a bogus “invoice reconciliation audit” done by UnitedHealth Services.

According to the complaint, such audits try to find out if the pharmacy is submitting fraudulent claims. But Cedra says the audit was “unprecedented and illogical” because the Houston pharmacy had just opened and the audit was a thinly veiled attempt to justify denying it access to Catamaran/ORX’s network.

With its Houston pharmacy’s second application for admission into the network pending in September, Cedra says UnitedHealth Group audited its flagship pharmacy in the Bronx and three other Cedra pharmacies in New York City.

“These audits ultimately concluded with no negative findings, but the timing of the simultaneous audits, which coincided with applications for Cedra Houston, Cedra Dallas, and Cedra LA, was meant to send a message to Cedra owners: back down,” the complaint states.

Cedra says UnitedHealth Group’s CEO has made clear its goal of squeezing Cedra out of the specialty pharmacy business to grab a bigger share of the market.

“UnitedHealth’s CEO recently stated, regarding defendants, that: ‘We have strong momentum in specialty pharmacy, where we expect full year 2017 revenues to increase 20% over last year and growth momentum to continue into 2018,’” the lawsuit states, quoting CEO David Wichmann during an Oct. 17 earnings call in which he reported company revenue of $50.3 billion for the third quarter of 2017.

Cedra seeks treble damages for lost profits caused by UnitedHealth Care’s denial under the federal Racketeer Influenced and Corrupt Organizations (RICO) Act and Sherman Act. It also makes Texas law claims of unfair competition and tortious interference and says the UnitedHealth Group defendants violated a California “fair procedure” law.

UnitedHealth Group did not respond Tuesday to a request for comment.

UnitedHealth Group’s subsidiary UnitedHealth Care Services Inc. and several companies that merged to form UnitedHealth Group’s pharmacy benefit management business Catamaran/OptumRx are also named as defendants in the case.

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