In Re: National Prescription Opiate Litigation
(Exhibit B – 3.28.24 hearing transcript)Related document(s)
It is only 160+ pages
Filed under: General Problems | Leave a Comment »
R.I.P. Robert Charles Foster: suicide by cop
Posted on May 3, 2024 by Pharmaciststeve
R.I.P.
Robert Charles Foster
Robert Charles Foster
Robert Charles Foster, a male from Oregon died by suicide. ‘(or as he phrased it, “suicide by cop”). Foster told the police during a previous suicide attempt, “I had been in chronic, constant pain, and was for whatever reason, not able to get the medication he needed for it.” He was 65 years old. He came out of a building with a gun, and would not drop it, on the command from the police. They shot and killed him – this was his intention.’
Filed under: General Problems | 6 Comments »
Pain Management Physician Convicted of Unlawfully Distributing Opioids
Posted on May 3, 2024 by Pharmaciststeve
Notice in this DOJ press release, that they stated that individuals traveled hundreds of miles to obtain prescriptions for opioids and other controlled substances – one of those DEA RED FLAGS. Generally, RED FLAGS are policies that the DEA adopts from observing what many/addicts/diverters do. Let’s look at the simple math. Over a ~ 6-year period of time, Romano prescribed 137,000 doses of three controlled substances to 9 pts. 137,000/6 yrs = 22,833 doses given to 9 pts = 2,537 doses to each pt which equals ~ a total of 7 doses of those three meds daily – on average. That could break down to, 2 opioids a day, 4 muscle relaxants a day, and a benzodiazepine at bedtime for sleep. Not knowing the mgs of each med, this could be appropriate for many pts dealing with intractable chronic pain!
I noticed that there was no mention of any of his pts ODing/dying, and the pts were addicted to these medications. Do they know the difference between addiction and dependency when these categories of meds are appropriately prescribed long-term? It took 3 attorneys from the Criminal Division’s Fraud Section, “gin-up” 24 counts against Romano. Of course, each count could be worth 20 yrs in prison for Romano. Given Romano’s age (73 y/o), one count could end up being a LIFE SENTENCE, let alone the 480 yrs Romano is potentially looking at.
Pain Management Physician Convicted of Unlawfully Distributing Opioids
https://www.justice.gov/opa/pr/pain-management-physician-convicted-unlawfully-distributing-opioids-0
A federal jury in the Southern District of Ohio convicted an Ohio physician today for unlawfully distributing opioids from his clinic.
According to court documents and evidence presented at trial, Thomas Romano, 73, of Wheeling, West Virginia, owned and operated a self-named pain management clinic in Martin’s Ferry to which individuals traveled hundreds of miles to obtain prescriptions for opioids and other controlled substances. Romano charged $750 for an initial visit and $120 for subsequent monthly visits. The prescriptions Romano issued for opioids and other controlled substances greatly exceeded recommended dosages and were in dangerous, life-threatening combinations that fueled the addiction of the individuals to whom he prescribed. Between October 2014 and September 2019, Romano prescribed over 137,000 pills, including opioids, benzodiazepines, and muscle relaxants, to nine individuals.
The jury convicted Romano of 24 counts of unlawful distribution of a controlled substance, outside the usual course of professional practice, and not for a legitimate medical purpose to nine individuals. He faces a maximum penalty of 20 years in prison for each charge. A sentencing date has not yet been set. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
Acting Assistant Attorney General Nicole M. Argentieri of the Justice Department’s Criminal Division, U.S. Attorney Kenneth L. Parker for the Southern District of Ohio, Special Agent in Charge Orville O. Greene of the Drug Enforcement Administration (DEA) Detroit Division, Special Agent in Charge J. William Rivers of the FBI Cincinnati Field Office, and Special Agent in Charge Mario M. Pinto of the Department of Health and Human Service Office of the Inspector General (HHS-OIG) made the announcement.The DEA, FBI, and HHS-OIG, as well as the Ohio Bureau of Worker’s Compensation and Ohio Board of Pharmacy, investigated this case.
Assistant Chief Alexis Gregorian and Trial Attorneys Devon Helfmeyer and Danielle Sakowski of the Criminal Division’s Fraud Section are prosecuting the case.
The Fraud Section leads the Appalachian Regional Prescription Opioid (ARPO) Strike Force. Since its inception in late 2018, ARPO has partnered with federal and state law enforcement agencies and U.S. Attorneys’ Offices throughout Alabama, Kentucky, Ohio, Virginia, Tennessee, and West Virginia to prosecute medical professionals and others involved in the illegal prescription and distribution of opioids. Over the past four years, ARPO has charged over 115 defendants, collectively responsible for issuing prescriptions for over 115 million controlled substance pills. To date, more than 60 ARPO defendants have been convicted. More information can be found at www.justice.gov/criminal-fraud/health-care-fraud-unit.
Filed under: General Problems | 4 Comments »
Equal Protection Clause- another law on the books to protect chronic pain pts
Posted on May 2, 2024 by Pharmaciststeve
Equal Protection Clause
https://en.wikipedia.org/wiki/Equal_Protection_Clause
The Equal Protection Clause is part of the first section of the Fourteenth Amendment to the United States Constitution. The clause, which took effect in 1868, provides “nor shall any State … deny to any person within its jurisdiction the equal protection of the laws.” It mandates that individuals in similar situations be treated equally by the law.[1][2][3]
A primary motivation for this clause was to validate the equality provisions contained in the Civil Rights Act of 1866, which guaranteed that all citizens would have the guaranteed right to equal protection by law. As a whole, the Fourteenth Amendment marked a large shift in American constitutionalism, by applying substantially more constitutional restrictions against the states than had applied before the Civil War.
The meaning of the Equal Protection Clause has been the subject of much debate, and inspired the well-known phrase “Equal Justice Under Law“. This clause was the basis for Brown v. Board of Education (1954), the Supreme Court decision that helped to dismantle racial segregation. The clause has also been the basis for Obergefell v. Hodges which legalized same-sex marriages, along with many other decisions rejecting discrimination against, and bigotry towards, people belonging to various groups.
While the Equal Protection Clause itself applies only to state and local governments, the Supreme Court held in Bolling v. Sharpe (1954) that the Due Process Clause of the Fifth Amendment nonetheless requires equal protection under the laws of the federal government via reverse incorporation.
Filed under: General Problems | 2 Comments »
Warren Blasts United Health CEO for Monopolistic Practices that Harm Patients
Posted on May 2, 2024 by Pharmaciststeve
CVS Health stock price drops nearly 20% in two days
Posted on May 2, 2024 by Pharmaciststeve
This could be the proverbial “canary in the coal mine”. Several major healthcare providers did not renew their contracts with a number of Medicare-C (Advantage) programs for 2025.
All insurance providers of Medicare-C and Medicare-D are FOR PROFIT. CVS stated in this article that it experienced increased Medicare utilization. If you have Medicare-C or Medicare-D insurance, you might want to carefully read the new policy you will be signing up for during open enrollment – October 15th to December 7 2024 for insurance coverage for 2025.
CVS Health drops as medical cost trends prompt guidance cut
CVS Health (NYSE:CVS) shares traded sharply lower in the premarket on Wednesday after the pharmacy chain operator reported lower-than-expected Q1 2024 financials and slashed its full-year outlook below consensus, citing medical cost trends.
While the Woonsocket, Rhode Island-based healthcare giant’s revenue for the quarter rose ~4% YoY to $88.4B, exceeding expectations, its Health Services segment, which includes its PBM unit Caremark, underperformed.
CVS’ Health Services segment added $40.3B to the topline, indicating a ~10% YoY drop due to multiple reasons, including the loss of a major client during the period.
However, the company’s Health Care Benefits segment, which houses its insurance arm Aetna, and CVS’ Pharmacy & Consumer Wellness segment outperformed, bringing in $33.2B and $28.7B in revenue with ~25% YoY and ~3% YoY growth, respectively.
Meanwhile, CVS’ bottom line fell during the quarter, with adjusted earnings per share reaching $1.31 with a ~41% YoY drop as the company’s adjusted operating income slumped ~32% YoY to $3.0B amid declines in the Health Care Benefits and Health Services segments.
In the Health Care Benefits unit, adjusted operating income decreased by ~60% YoY to $732M as the medical benefits ratio, which calculates the share of premiums spent on medical benefits, reached ~90% compared to ~85% a year ago.
CVS attributed the MBR spike to several factors, including increased Medicare utilization and the unfavorable impact of the company’s 2024 Medicare Advantage star ratings.
“We are confident we have a pathway to address our near-term Medicare Advantage challenges,” CEO Karen Lynch remarked ahead of the conference call at 8:00 a.m. EST. “We remain committed to our strategy and believe that we have the right assets in place to deliver value to our customers, members, patients, and shareholders.”
However, expecting the pressure on medical utilization to continue to impact its Health Care Benefits segment throughout the year, the company lowered its 2024 adj. EPS outlook to at least $7.00 from at least $8.30, compared to $8.27 in the consensus.
With CVS citing pressure on medical utilization, shares of other health insurers will be in focus. In January, Humana (HUM) led a selloff among health insurers such as UnitedHealth (UNH), Alignment Healthcare (ALHC), Elevance Health (ELV), and Centene (CNC) after the managed care provider set its 2024 outlook below consensus, expecting a spike in medical costs to continue this year.
Filed under: General Problems | Leave a Comment »
US poised to ease restrictions on marijuana in historic shift, but it’ll remain controlled substance
Posted on May 1, 2024 by Pharmaciststeve
This poses an interesting conundrum. Being de-classified to a C-3, may encourage some pharmas to do some clinical research on some of the components of MJ. MJ being classified as a C-1 prohibited research. I have read that there have been at least 100 different components isolated from MJ and there may be that many or more that have yet to be isolated.
If it is made an Rx-only item, I doubt if any insurance will pay for it, but states will lose a lot of sales tax. Since all Rxs are sales tax-free.
US poised to ease restrictions on marijuana in historic shift, but it’ll remain controlled substance
WASHINGTON (AP) — The U.S. Drug Enforcement Administration will move to reclassify marijuana as a less dangerous drug, The Associated Press has learned, a historic shift to generations of American drug policy that could have wide ripple effects across the country.
The proposal, which still must be reviewed by the White House Office of Management and Budget, would recognize the medical uses of cannabis and acknowledge it has less potential for abuse than some of the nation’s most dangerous drugs. However, it would not legalize marijuana outright for recreational use.
The agency’s move, confirmed to the AP on Tuesday by five people familiar with the matter who spoke on the condition of anonymity to discuss the sensitive regulatory review, clears the last significant regulatory hurdle before the agency’s biggest policy change in more than 50 years can take effect.
Once OMB signs off, the DEA will take public comment on the plan to move marijuana from its current classification as a Schedule I drug, alongside heroin and LSD. It moves pot to Schedule III, alongside ketamine and some anabolic steroids, following a recommendation from the federal Health and Human Services Department. After the public comment period and a review by an administrative judge, the agency would eventually publish the final rule.
The proposal will be formally signed by Attorney General Merrick Garland, whose agency has ultimate oversight of the DEA, according to another person familiar with the process who spoke on the condition of anonymity to discuss internal deliberations. Garland’s signature throws the full weight of the Justice Department behind the move and appears to signal its importance to the Biden administration.
It comes after President Joe Biden called for a review of federal marijuana law in October 2022 and moved to pardon thousands of Americans convicted federally of simple possession of the drug. He has also called on governors and local leaders to take similar steps to erase marijuana convictions.
“Criminal records for marijuana use and possession have imposed needless barriers to employment, housing, and educational opportunities,” Biden said in December. “Too many lives have been upended because of our failed approach to marijuana. It’s time that we right these wrongs.”
The election year announcement could help Biden, a Democrat, boost flagging support, particularly among younger voters.
Biden and a growing number of lawmakers from both major political parties have been pushing for the DEA decision as marijuana has become increasingly decriminalized and accepted, particularly by younger people. A Gallup poll last fall found 70% of adults support legalization, the highest level yet recorded by the polling firm and more than double the roughly 30% who backed it in 2000.
The DEA didn’t respond to repeated requests for comment.
Schedule III drugs are still controlled substances and subject to rules and regulations, and people who traffic in them without permission could still face federal criminal prosecution.
Some critics argue the DEA shouldn’t change course on marijuana, saying rescheduling isn’t necessary and could lead to harmful side effects.
Jack Riley, a former deputy administrator of the DEA, said he had concerns about the proposed change because he thinks marijuana remains a possible “gateway drug,” one that may lead to the use of other drugs.
“But in terms of us getting clear to use our resources to combat other major drugs, that’s a positive,” Riley said, noting that fentanyl alone accounts for more than 100,000 deaths in the U.S. a year.
On the other end of the spectrum, others argue marijuana should be treated the way alcohol is.
Last week, 21 Democrats led by Senate Majority Leader Sen. Chuck Schumer of New York sent a letter to DEA Administrator Anne Milgram and Attorney General Merrick Garland arguing marijuana should be dropped from the controlled-substances list and instead regulated like alcohol.
“It is time for the DEA to act,” the lawmakers wrote. “Right now, the Administration has the opportunity to resolve more than 50 years of failed, racially discriminatory marijuana policy.”
Federal drug policy has lagged behind many states in recent years, with 38 having already legalized medical marijuana and 24 legalizing its recreational use.
That’s helped fuel fast growth in the marijuana industry, with an estimated worth of nearly $30 billion. Easing federal regulations could reduce the tax burden that can be 70% or more for businesses, according to industry groups. It could also make it easier to research marijuana, since it’s very difficult to conduct authorized clinical studies on Schedule I substances.
The immediate effect of rescheduling on the nation’s criminal justice system would likely be more muted, since federal prosecutions for simple possession have been fairly rare in recent years.
But loosening restrictions could carry a host of unintended consequences in the drug war and beyond.
Critics point out that as a Schedule III drug, marijuana would remain regulated by the DEA. That means the roughly 15,000 cannabis dispensaries in the U.S. would have to register with the DEA like regular pharmacies and fulfill strict reporting requirements, something that they are loath to do and that the DEA is ill equipped to handle.
Then there’s the United States’ international treaty obligations, chief among them the 1961 Single Convention on Narcotic Drugs, which requires the criminalization of cannabis. In 2016, during the Obama administration, the DEA cited the U.S.’ international obligations and the findings of a federal court of appeals in Washington in denying a similar request to reschedule marijuana.
Filed under: General Problems | Leave a Comment »
ProPublica Creates a Tool to Hold Payers Accountable
Posted on April 29, 2024 by Pharmaciststeve
ProPublica Creates a Tool to Hold Payers Accountable
https://www.daily-remedy.com/propublica-creates-a-tool-to-hold-payers-accountable/
Series: Uncovered: How the Insurance Industry Denies Coverage to Patients
Health insurers reject millions of claims for treatment every year in America. Corporate insiders, recordings and internal emails expose the system and its harm.
Just outside public view, the American health insurance industry’s algorithms, employees and executives process tens of millions of claims for people seeking medical care.
Sometimes, as ProPublica has reported, insurers base decisions on what’s good for the company’s bottom line rather than what’s good for the patient’s health. Sometimes, insurers make mistakes. In one case we learned about, a company denied a child’s treatment because it based its judgment on adult guidelines instead of pediatric ones. In another, an internal reviewer misread what type of surgery the patient sought and denied coverage based on that error.
At first, these patients had no idea why they were denied treatment. But in each instance, insurance employees left a paper trail — in notes, emails or recordings of phone calls — explaining what happened. Patients and advocates used what they found in those records to craft appeals and ultimately receive the care they needed.
Federal law and regulations require insurers to hand over exactly this sort of information in response to a written request. And they have to do it fast: Most people who get insurance through an employer should get the records, called claim files, within 30 days.
There’s just one catch: Some insurers aren’t turning files over like they’re supposed to. We followed ProPublica readers through the process with five different insurers. Several companies only shared documents with patients after we reached out.
Our team discovered how useful claim files can be after a patient shared internal notes and calculations that a health insurer had made about his case. But few health insurers advertise this service or offer clear instructions for getting these records. To help fill that gap, we published a guide explaining how to submit a claim file request. We also shared resources with health care providers and patient advocates nationwide, including request letter templates.
More than 120 people have told us that they have since requested or intend to request their claim files. Though a handful say they received information that helped them understand why their health insurer denied coverage, many more have been running into challenges. They’ve told us about insurers blowing past deadlines, wrongly requiring subpoenas and — in several cases — misinterpreting their request entirely.
We shared a summary of these examples with Tim Hauser, a deputy assistant secretary with the Department of Labor. His office oversees claim file laws that cover more than 131 million people. He said insurers who fail to provide records are breaking the law. “The claimant really needs to be able to see what the relevant evidence is so that they can respond to it,” he said.
We brought our findings to five insurance companies. We presented them with details about the requests patients had made and how the company had responded, and we asked for an explanation of what happened in each case.
All of the insurers acknowledged that the patients were entitled to the material they’d asked for. Four began sending the files after our inquiry. Two, spokespeople told us, are updating policies to handle future requests. Anthem Blue Cross Blue Shield spokesperson Michael Bowman said the company needed to better train staff on the rules “to close any gaps to prevent this from occurring in the future.” Cigna spokesperson Justine Sessions admitted that patients do not need a subpoena to access their records, contrary to what the insurer had told a member. She said the company would update its “policies and communications to reflect that for future requests. We regret that we did not make these updates sooner and apologize for any frustration or confusion this has caused our customers.”
By crowdsourcing people’s experiences, we identified some patterns in health insurers’ behavior. Here are some of the most common issues people encountered — and what to watch out for if you submit your own request:
Insurers Asking for Unnecessary Subpoenas or Court Orders
Cigna and Anthem told members that they would need to obtain a court order or subpoena to access their claim file records.
“This is completely unheard of,” said Wells Wilkinson, a senior attorney with the nonprofit legal group Public Health Advocates who regularly files these requests. “It also sounds completely illegal. The consumer has the right to any information used by the health plan in the context of the denial.”
On July 12, Lisa Kays, a Maryland resident, asked Cigna for phone call records related to its decision to deny coverage for her 4-year-old son’s speech therapy. “We couldn’t afford to just give up,” Kays said.
In September, Cigna sent her a letter saying she would need to submit a subpoena to get any transcripts or recordings.
After ProPublica inquired, the company sent Kays partial transcripts of the calls. It also reimbursed her for some of the previously denied coverage. She is still waiting for the recordings.
We asked Anthem about a similar case. On July 19, a call center agent told Pamela Tsigdinos she would need a subpoena to receive her claim file records. Tsigdinos had submitted the request 50 days earlier.
Bowman, the Anthem spokesperson, told us the response was an error and apologized. The company compiled the claim file and sent it to Tsigdinos.
Insurers Confusing Claim File Requests With Appeals
At least five people told ProPublica that, after submitting a request for a claim file, their health insurer mistook the request for an appeal.
We brought three cases to UnitedHealthcare. S.J. Farris requested her claim file from the company on May 10. Five days later, she received a response stating that her request for an appeal had been received. Farris sent a clarifying letter but was met with a call from an appeals agent based in Ireland. “I asked her to send the claim files,” Farris said. “She had no idea what I was talking about.”
After ProPublica sent the company questions, Farris received a call from UnitedHealth in October. They told her that the insurer was working on her claim file and that she should expect it soon. In a statement to ProPublica, UnitedHealth spokesperson Maria Gordon Shydlo said: “We take our responsibility to provide members access to their records seriously and have processes in place to comply with the law. We are sorry for any inconvenience.”
After Beth Tolley sent Anthem a claim file request on behalf of her granddaughter, she received a letter from the health insurer stating, “We’ve received a request from Beth Tolley for an appeal.” This left Tolley confused since, in its last communication, Anthem had said all avenues of appeal with its office had been exhausted.
In early October, Anthem sent the Tolley family a check for the amount it had initially declined to cover. Bowman told ProPublica that the company would be sending the records soon.
Insurers Blowing Past the 30-Day Deadline
For most people who get insurance through their employers, insurers are required to send claim files back within 30 days, according to federal law.
Twelve of the people whose requests ProPublica followed did not receive their records within that time frame even though they had these types of plans. Five of those had been waiting for responses from their insurers for more than 70 days before ProPublica contacted the companies with questions.
Isabella Gonzalez submitted a claim file request via certified mail on Aug. 8. When she called Aetna to get an update, a representative told her they did not see it in the system and advised her to upload it onto the insurer’s online portal, which she did. She called back a few days later. A different customer service employee told her Aetna would respond in 45 days.
Alex Kepnes, the executive director of communications for Aetna, said the company at first did not recognize what Gonzalez was asking for and therefore did not respond to it.
Kepnes declined to respond to follow-up questions about why staff failed to correctly identify the request and whether the company would be taking action to ensure this does not happen again.
Other companies that failed to follow the 30-day timeline include UnitedHealth, Anthem and Cigna.
“It’s really important that these responses be timely,” said Hauser, the Department of Labor official. “If that’s not happening, it’s really contrary to the regulation.”
Filed under: General Problems | Leave a Comment »
FTC makes strides to boost competition and hold PBMs accountable
Posted on April 25, 2024 by Pharmaciststeve
FTC makes strides to boost competition and hold PBMs accountable
Two pieces of news about the Federal Trade Commission (FTC) that will affect the health care community. Chair Lina Khan revealed this week that an update into the agency’s investigation of pharmacy benefit managers will be released in the coming months, far sooner than planned, bowing to pressure from Congress and taking into account NCPA’s tireless advocacy efforts. (In March, NCPA co-hosted a Small Business Rising Coalition event with Khan, and earlier this month, Khan participated in a roundtable of community pharmacists in Pennsylvania co-hosted by NCPA—among the first organizations to cheer the FTC when it launched its inquiry into insurer PBM practices in 2022.) The second piece of news will have a broader impact on the health care industry. On Tuesday, the FTC finalized a rule banning noncompete agreements for all American workers—agreements that hospitals have widely used for years to retain their physicians and prevent them from bouncing to another hospital. “Noncompete clauses keep wages low, suppress new ideas, and rob the American economy of dynamism, including from the more than 8,500 new startups that would be created a year once non-competes are banned,” said Khan in an FTC press release. “The FTC’s final rule to ban non-competes will ensure Americans have the freedom to pursue a new job, start a new business, or bring a new idea to market.” To counter, the U.S. Chamber of Commerce and other business groups filed a lawsuit yesterday seeking to block the noncompete ban, as reported by the Wall Street Journal and other outlets. This is an ongoing story and we’ll keep you posted.
Filed under: General Problems | Leave a Comment »
APDF goes to Washington DC to lobby members of Congress -042424
Posted on April 25, 2024 by Pharmaciststeve
Filed under: General Problems | 5 Comments »