Aetna settles suit alleging claim-denying medical director never read patient’s records

Aetna settles suit alleging claim-denying medical director never read patient’s records

https://www.cnn.com/2019/04/26/health/aetna-settlement-california-investigation/index.html

Aetna has settled a lawsuit in which a company medical director said under oath that he never looked at patients’ records when deciding whether to approve or deny coverage — testimony that prompted an investigation by the California insurance commissioner.

The health insurance giant had vowed to fight the case, saying the medical director’s comments were taken out of context, and strongly defended its policies amid a firestorm after CNN broke the story in February 2018. “When those policies are called into question,” Aetna said at the time, “we will defend them.”
Aetna, which was acquired in November by CVS Health in a nearly $70 billion merger, offered no explanation as to why it chose not to defend its policies in court. The settlement was reached in late March, ahead of trial, according to the parties involved.
“We don’t comment on legal settlements, which are commonplace and by no means an admission of wrongdoing,” said T.J. Crawford, vice president of external affairs for CVS Health.
The terms of the agreement were not released.
“The matter has been resolved to the parties’ mutual satisfaction,” said Scott Glovsky, the attorney representing plaintiff Gillen Washington, who has a rare immune disorder and was a college student when he was first denied coverage.
The office of the California Department of Insurance said it could not comment because its investigation of Aetna is ongoing. Commissioner Ricardo Lara took over this year from Dave Jones, who launched the inquiry in February 2018.
At the time, Jones told CNN that he found it troubling “if the health insurer is making decisions to deny coverage without a physician actually ever reviewing medical records.”
“It’s hard to imagine that, in that entire course in time, there weren’t any cases in which a decision about the denial of coverage ought to have been made by someone trained as a physician, as opposed to some other licensed professional,” Jones said.
News of the settlement raised eyebrows in the legal community. “In my experience with Aetna, they don’t settle cases easily, despite their public pronouncements in the media,” said Doug Terry, an Oklahoma attorney who won a $25 million verdict against Aetna last fall over a “bad faith” case in which a cancer patient was denied coverage.
Arthur Caplan, the director of medical ethics for New York University’s School of Medicine, said he and others in the medical community hoped the settled case would shed light on the way Aetna’s medical directors make coverage decisions.
“Given the importance of how benefits determinations are made by Aetna and other companies, I would hope we could get more transparency of their procedures,” Caplan said. “I thought it might come out of this case, but sadly it doesn’t appear so.
“Hopefully, they’ll be more willing to be transparent on down the road. They should be.”
Washington sued Aetna for breach of contract and bad faith in 2015, saying he was denied coverage for an infusion of intravenous immunoglobulin (IVIG) when he was 19. His suit alleged that Aetna’s “reckless withholding of benefits almost killed him.”
In court filings, Aetna rejected the allegations, saying Washington failed to comply with its requests for blood work. Once his blood was tested, Aetna said, the insurer resumed covering his infusions.
The California insurance commissioner’s investigation revolves around the deposition of Dr. Jay Ken Iinuma, who served as medical director for Aetna for Southern California from March 2012 to February 2015.
During his videotaped deposition in October 2016, Iinuma acknowledged more than once that he did not look at medical records, saying he was following Aetna’s training, in which nurses reviewed records and made recommendations to him.
At one point, he even went out of his way to correct Glovsky, the patient’s attorney. Glovsky had begun to ask about the need to see medical records during a case review when Iinuma corrected him, saying, “the first part of this question was ‘I’d have to review medical records,’ and that’s not true, because the nurse preparing the case would look through the medical … records and provide me with the information required, such as lab values. So that’s why I had to make a little correction there.”
The doctor also said he knew next to nothing about Washington’s condition and wasn’t sure what the drug of choice would be for people with his disorder.
“How would you decide on your own when to actually review the medical records versus relying on what the nurse at Aetna had prepared for you?” Glovsky said.
“What percentage?” Iinuma asked.
Glovsky: “I mean, like, did you ever look at medical records or basically whenever –“
Iinuma: “No, I did not.”
Glovsky: “OK. So as part of your custom and practice in making decisions, you would rely on what the nurse had prepared for you?”
Iinuma: “Correct.”
Glovsky: “Instead of actually looking at yourself the medical records?”
Iinuma: “Correct.”
Glovsky: “And was that throughout your — your years at Aetna?”
Iinuma: “My tenure, yes.”
Glovsky: “Was that how you were trained to do it when you joined — first joined Aetna?”
Iinuma: “To my recollection, yes.”
When Iinuma had a chance to amend his comments after reviewing the deposition transcript, he signed an “errata sheet” on November 30, 2016, in which he didn’t change those remarks and accepted them, under penalty of perjury, as “true and correct.”
Shortly after CNN reported on the deposition and the investigation by the California insurance commissioner, Aetna released a new sworn statement from Iinuma in which he appeared to indicate that he misunderstood Glovsky’s questions. Glovsky was not present when the new statement was taken.
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“When I stated at the deposition that I never looked at a ‘medical record’ while at Aetna, I understood the term ‘medical record’ to refer to the entirety of a patient historical file containing all charts, doctors’ notes, laboratory tests, and any other report generated by a treating provider for that patient,” Iinuma said in the statement.
“In my mind, and based on my experience, this is the definition of a patient’s ‘medical record’ — a record of their treatment and medical history. Not only is a patient’s medical record generally a very large file or files, in my experience neither patients nor providers submit the entirety of a patient’s medical record to Aetna. Patients and providers submit only portions of a patient’s medical record for Aetna’s review.”
The story was shared far and wide by doctors, patients and others in the medical community.
Angered by the media glare after CNN’s story, the California Superior Court judge delayed the trial start last year. After more delays, the trial was set to begin this spring.

SC: The bill, H.4352 Parents want ban on energy drinks for minors after son’s death

Parents want ban on energy drinks for minors after son’s death

https://www.msn.com/en-us/news/us/parents-want-ban-on-energy-drinks-for-minors-after-sons-death/ar-BBWmmAV

A bill that would ban the sale of energy drinks to those under 18 years of age passed a subcommittee of South Carolina lawmakers Friday. 

The bill, H.4352, was filed by Representative Leon Howard (D-Richland) and Representative Chip Huggins (R-Lexington. It’s also being supported by Sean and Heidi Cripe, two Midland parents who lost their son after he drank too much caffeine. 

Two years ago Davis Cripe, 16 at the time, drank a coffee, soda, and limu drink within two hours. He collapsed in class, and later died. 

RELATED: Excessive Caffeine Led to Death of Midlands Teen, Coroner Says

“He loved life. He lived it loud,” said Sean Cripe as he spoke with the NBC affiliate in Columbia, WIS-TV. “He had drank an energy drink before class and he had gotten sick really quick. Within a matter of minutes, he had lost his life.”

A Richland County coroner ruled Davis died from a caffeine-induced cardiac event. 

His parents are wanting to keep other families from enduring their tragedy. 

However, not everyone agrees, including medical professionals.

“Fatal caffeine overdose from energy drink ingestion is impossible,” said Dr. Ashley Roberts as he testified before the subcommittee. 

“Diagnosis of death caused by a drug is a diagnosis of exclusion. You need to make sure everything else is okay. The heart is okay, the kidney is okay and then you need to look at the drug,” added Dr. Donna Seger, an emergency physician and medical toxicologist.

The Cripe family disagrees. 

“It’ll be huge. Not only for our son Davis but knowing that here on out other kids will be protected,” said Heidi Cripe. 

The bill now moves to full committee. 

 

 

Request for Comments: Analgesic Drug Products Advisory Committee

Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

https://www.regulations.gov/document?D=FDA-2019-N-1646-0001

Summary

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

Dates

The meeting will be held on June 11, 2019, from 8 a.m. to 5 p.m. and June 12, 2019, from 8 a.m. to 5 p.m.

Addresses

FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2019-N-1646 . The docket will close on June 30, 2019. Submit either electronic or written comments on this public meeting by June 30, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before June 30, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 30, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Comments received on or before May 28, 2019, will be provided to the committees. Comments received after that date will be taken into consideration by FDA.

Your Brain On Drug Policy | Rachael Leigh Cook (2017)

CVS limits Insulin Dependent pts to 3 glucose test strips/day billed to Medicare Part B

CVS Introduces Limit on Glucose Strips

www.nbcnewyork.com/on-air/as-seen-on/CVS-Introduces-Limit-on-Glucose-Strips_New-York-509231382.html

According to this report… CVS has decided to only allow 3 glucose test strips for Insulin dependent pts and it is being billed to Medicare Part B. Even though Medicare Part B will reimburse for 4 tests strips a day.

According to this article, the news reporter reached out to CVS and their response was that they suggested that this pt get her glucose test strips at another pharmacy.

I would hope that this woman takes ALL OF HER PRESCRIPTIONS TO ANOTHER PHARMACY and hopes that her doctor suggests to all of her pts that they find another pharmacy to take care of their medication needs.

PRESS RELEASE from Nealy Tynes, President, International OPERATION PAIN RELIEF

PRESS RELEASE from Nealy Tynes, President, International OPERATION PAIN RELIEF

www.nationalpainreport.com/press-release-from-nealy-tynes-president-international-operation-pain-relief-8839697.html

PRESS RELEASE
4-28-19

In 2010 the Department of Defense told us there were 18 vets of foreign wars dying by suicide everyday in Washington state.  That is approximately 6,570 per year.

Now, it’s 2019 and the suicide rate is increasing dramatically in Washington state each day, not only by the vets of foreign wars, but include cancer patients, fibromyalgia patients, RSD/CRPS patients, etc., who are all untreated for their pain.

Washington state was considered the first “Pilot Project” state in America, back in 2010.  Now there are 6 pilot project states in the union.

Whatever passed in Washington state, passed nationwide.  Blame ESHB 2876, sponsored and written by Jim Moeller (House Rep), in 2010.

I read it.  There were no facts, or findings of law in Jim’s Bill.  It was simply hearsay, and a story.  No proof of what he wrote was backed up by any documentation.

ESHB 2876 was about a story of children getting into their parents medicine cabinets, finding pill bottles, overdosing, while their parents were not at home.

And, that my friends, became law.  It was merely a story.

I interviewed each of the House of Representatives in the Washington state, Olympia, legislators’ offices.  Each and everyone of them had a ‘boiler plate’ answer to me.  They said:  “I was told to not read it, and to not research it, but to sign it and send it up the governor’s office.”  Governor Christine Gregoire then passed it into law.

I found out later, during my investigation, that the FDA pressured the legislators into signing ESHB 2876.

I confronted the FDA, and told them they have no jurisdiction over our Washington state legislators, and they need to get the hell out of our state, and don’t ever come back.

In the meantime, the doctors started leaving our state in droves.  There were none to be found who would take chronic pain patients, and the suicide rate climbed even further.

I was sad.  I was angry.  I was in shock.  I felt helpless.

But, God had a plan for me, and I kept advocating anyway, to the best of my ability.

Then I became empowered by FACEBOOK.  A whole new world opened up for me, and now I am on fire, and grateful.

Please share this PRESS RELEASE.

Signed, Nealy Tynes
President, International OPERATION PAIN RELIEF
Email:  opr.1@juno.com

 

 

Oregon: HERC members talking about chronic pain patients after they left the meeting

Published on Apr 3, 2019

Shorter version. HERC Meeting March 14th 2019. HERC members talking about chronic pain patients after they left the meeting. What was expected to be the final vote on the chronic pain task force proposal for medicaid, was paused they say, to investigate a possible conflict of interest by members and staff of HERC. This portion of the HERC meeting was a roundtable style discussion with the Chief Medical Officer of the OHA, and voting members of HERC, some of whom are also members of the chronic pain task force. * Introduction to the HERC meeting begins at the 38 min mark and goes to the 50 min mark. The audio begins with the HERC and OHA Chief discussions and how the HERC profiles and sees patients who testify and who they serve in a public health position. OHA Public News Release on pause: https://www.oregon.gov/oha/ERD/Pages/… World renouned pain experts have spoken out – against.. Oregon’s radical medicaid population experiment. Sean Mackey, MD, PHD Chief, Division of Pain Medicine Expert letter and Expert signatures https://static1.squarespace.com/stati…

 

 

 

 

Express Scripts won’t cover Eli Lilly’s new generic insulin

Insulin pens on an assembly line.Express Scripts won’t cover Eli Lilly’s new generic insulin

https://www.axios.com/express-scripts-wont-cover-eli-lilly-insulin-lispro-37c347da-9383-425c-b3f2-8af755f7a1ae.html

Eli Lilly’s new “authorized generic” of its pricey Humalog insulin, called Lispro, is excluded from the 2019 national list of covered drugs from pharmacy benefit manager Express Scripts.

The big picture: So much for all the fanfare when Eli Lilly unveiled the insulin last month. Lispro’s price doesn’t change net spending on the insulin, even though it is cheaper for people paying cash out of pocket, and PBMs have little incentive to cover the drug if a rebate doesn’t exist or is tiny.

 

Does this just give everyone just one more proof that the PBM’s  – which Express Scripts is one of the top three, along with CVS’s Caremark and United Health’s Optium Rx – are more part of the problem of high Rx prices than part of the solution.   Apparently Lilly is paying little to nothing in the format of rebates, discounts or KICKBACKS.  The PBM industry was created as an answer to the UAW’s (Ford, GM, Chrysler, International Harvester, John Deere)  new contract in the fall of 1969.  They were suppose to save everyone money…  back then they were < 5% of the Rx business …but..today they are involved in the pricing and paying for 90%+ of all prescriptions and larger percent of the Rx market they got.. the more that they got into “forcing” the pharmas’ to give them discounts, rebates, KICKBACKS if the pharma wanted one or more of their medications on their formulary … meaning that they would be covered without prior authorization or quantity limits.  I have read where some pharmas are have to pay some 40% -50% of the wholesale price to the PBM to get their meds on a particular formulary.

 

 

What Is Your State Doing About Pain?

What Is Your State Doing About Pain?

www.nationalpainreport.com/what-is-your-state-doing-about-pain-8839662.html

The Federation of State Medical Boards is meeting in Fort Worth, Texas this weekend—and the “opioid” crisis is on the agenda.

“The State Medical Boards must lead the effort on regulation of the opioid crisis. The DEA and other federal agencies must work with the Medical Boards to avoid confusion with physicians legitimately taking care of their patients.”

Sherif Zaafran, MD, tweeted out his comments made as the Federation meeting got underway.

Dr. Zaafran is the head of the Texas Medical Board and a member of the HHS Pain Management Best Practices Inter-Agency Task Force and a very important voice

Saturday, he will also moderate a discussion of nationally recognized leaders who will “discuss new steps in the effort to address the nation’s opioid crisis. Included on that panel is Vanila M. Singh, MD, MACM, who is the chair of the Pain Management Task Force that calls for patient-centered approach to improve treatment of pain.

That Task Force Draft Report received some 6,000 public comments and the HHS group will gather again in May to adopt it.

“The action is at the state level,” said Terri Lewis, Ph.D. “Pain patients and physicians need to ask their state medical boards, what are you doing now?”

Just this month, two federal agencies eased some previous guidance on opioid prescribing.

The Centers for Disease Control and Prevention said many physicians have misapplied the 2016 guideline that resulted in a serious reduction on opioid prescribing.  The CDC tacitly acknowledged many physicians’ responses to the opioid crisis went too far.

Earlier this month, the FDA issued a safety announcement that it said “identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering.”

These agencies have been receiving blowback—and plenty of it—from medical professionals who believe that the reaction to the “opioid crisis” tilted dangerously toward those who become addicted from opioids versus the million of chronic pain patients who were adversely affected by the physicians, insurers and state regulators reaction.

Here’s one of the National Pain Report stories on it.

The question now is what will the state medical boards do with this new information?

The answers may begin to come this weekend in Texas.

The DEA “playing games” most likely is NOT OVER

FDA issues the rules all other agencies must follow. No agency outranks FDA

AMA welcomes CDC’s revised view on opioids guidelines

After posting these last night and pulling the title of the posts from the article itself…  I started reviewing the “whole game” that is being played out between the DOJ/DEA, FDA, CDC  and countless other agencies and healthcare corporations and provider that are struggling with the CDC guideline.

I have stated many times before, that the one agency that is completely silent and/or missing from the conversations is the DEA .

In all of this, what has not been revised is the Controlled Substance Act (1970)  (CSA) and it appears that the DEA’s authority in using the CSA apparently remains UNCHANGED.

This is how the DEA could keep screwing with the chronic pain community:

 

 

  • The DEA controls the licenses of those who produce, prescribe or dispense controlled meds.
  •  The Pharmas:  the DEA still can raise/lower the annual production quotas that each pharma is allowed to produce each year. Opiate Rxs peaked in 2012 and end the ensuing years, the DEA has already decreased production quotas have been DECREASED abt 50% of what was allowed in 2012.
  • Wholesalers: the BIG THREE (Amerisource, McKesson, Cardinal controls about 80%+ of the medication market in the USA. Walgreens owns part of Amerisouce – not sure if it is a minority or majority interest. Cardinal is the primary wholesaler for CVS and Mc Kesson is the primary wholesaler for Rite Aid. The wholesaler Rochester Drug Cooperative, Inc – that was recently fined by the DEA for failing to report suspicious large pharmacy orders… it was reported that they are a “major wholesaler”, but they are really part of the “secondary wholesaler market” and are really “small potatoes” in the overall wholesaler market place.  In Jan 2017, Mc Kesson paid 150 million fine ( https://www.justice.gov/opa/pr/mckesson-agrees-pay-record-150-million-settlement-failure-report-suspicious-orders ) for the same violation that Rochester Drug Cooperative, Inc was accused of and at least one of Rochester’s exec is facing 10 yrs in jail.  DEA licenses wholesalers and can fabricate charges against wholesalers, fine the crap out of them and suspend the DEA licensed to one or more distribution centers.
  • Prescribers:  We have seen the DEA fabricate charges and raid prescribers offices, close their practice down, use civil asset seizure laws to confiscate all their assets and put them in the DEA’S coffer.  We have also seen the DEA use nothing but the number of Rxs and/or doses to justify a raid on a practice.
  • Pharmacies: Pharmacies are licensed by the DEA, Pharmacists do not have a DEA license.  CVS was recently fined 535 million because the DEA claimed that several stores filled a total of 39 bogus C-II Rxs  https://patch.com/rhode-island/woonsocket/cvs-fined-535-000-filling-fake-opioid-prescriptions
  • Pharmacy & Medical licensing boards:  These boards usually “play along” with the DEA in fining or “busting” providers.  The Medical board is mostly staffed with DEA licensed prescribers and Pharmacy boards are mostly staffed with non-practicing corporate Pharmacists – whose chains that they work for does have DEA licenses in their pharmacies.
  • Then there is that part of the controlled substance act “Corresponding Responsibility”  ( https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm ) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.  Because the DEA’s statutory authority only concerns the diversion of controlled substances for illegitimate uses.. they have no authority – and thus doesn’t have to care – if valid prescription does not get filled and the valid medical need of a pt is met.

So with this revision of the CDC guidelines and the FDA getting on board, the authority and the actions of the DEA against all DEA license holders and chronic pain pts could remain unchanged.

We know that the DEA abt 4 yrs ago “forced” all of the drug wholesalers to RATION controlled substances to pharmacies which is a violation of the Interstate commerce law ( https://www.britannica.com/topic/interstate-commerce-United-States-law ) but when the entity (DOJ) that is suppose to be enforcing this law is the same entity that is causing the law to be violated… who do you turn to ?

You can ask the same question about the Americans with Disability Act and the discrimination against chronic pain pts when they are denied acceptance into a practice, a Rx filled at a pharmacy or some other issue ?

Hypothetical:  FDA/CDC and other oversight agencies implement policies and procedures that legit chronic pain pts are entitled to getting adequate pain therapy, but the DEA has continued to lower the pharma’s annual quota… wholesalers don’t have to forcibly ration controls to pharmacies …there will not be enough production to cover all the needs of acute and chronic pain pts.

Previously, I have been told that some pharmacies made sure that their “regular pts” got their pain meds and others fill controlled meds on a first come … first serve basis… when they ran out of a particular med towards the end of the month… everyone of their regular pts are just OUT OF LUCK ?

We all hear routinely, that the illicit use/abuse of controlled substances has DESTROYED families, but no one talks about how the CDC opiate dosing guidelines and their implementation has destroyed families as chronic pain pts have had their pain management therapy reduced or totally taken away.  

Let’s hope that the changes that are coming out from the CDC and FDA do not end up doing more damage than the original launch of the CDC opiates dosing guidelines has caused over the past three years because of the DEA, DOJ and our politicians being entrenched in believing that opiate prescribing to treat chronic pain is the gateway to people using/abuse illicit drugs and ODing.

They are using laws and breaking laws to deny pain pts their necessary medications… and IMO… the chronic pain community is never going to get justice and their needed medications unless they get their dollars together into a legal defense fund to level the playing field by engaging law firms or lobbyists to help us do that.