For starters, I am rather disappointed with one of the authors of this article  Kate M. Nicholson, she is a chronic pain pt and a civil rights attorney and in this article it is reported that 93,000 drug overdose deaths in 2020- which includes an estimated 15,000/yr deaths from the use/abuse of NSAIDS – mostly from GI bleeds and untold number of other drugs – legal and illegal….. and in the article stated that OD’s were largely due to Fentanyl – not ILLEGAL FENTANYL…according to Wikipedia there is some 400 known fentanyl analogs and ONLY ONE ANALOG is FDA legal for human use.  Historically, bureaucrats have used what they considered “socially unacceptable behavior” as a vehicle to generate tax revenue.  Just look at the sin taxes that have been added to Tobacco, Alcohol, Gambling over the years.  After nearly a half century of damning Marijuana as a DANGEROUS DRUG and ILLEGAL… 40 states have not legalized it use in some form or another. Some states – like Ohio – apparently decided that MJ was going to be a sizeable revenue stream and established taxes and fees on all segments of the MJ growing/distribution system that ONE OUNCE of MJ in Ohio is abt FOUR TIMES what it is in Colorado. BUT… MJ is still ILLEGAL at the Federal level.

I find it interesting that Senator Manchin introduced this bill whose Daughter, Heather Bresch, was CEO of Mylan… at one time a large pharma that produced opiate dosing,  before the company merged with another and the WV plant was closed – 1400 workers lost their job and operations was moved to India and Australia.  One would think that these 11 Senators would take notice what happened when NY implemented a opiate tax… the state of NY largely became a opiate desert.  The taxes and fees were imposed on the pharma and wholesaler and while they could pass those taxes and fees along to the pharmacies, the insurance companies/PBM would not reimburse the pharmacy for those added costs of those opiate to the pharmacies…. so pharmacies stopped ordering and/or filling opiate Rxs for Rxs that were being paid for by the pt’s insurance/PBM.  How many other pts dealing with chronic diseases are being taxed to treat others dealing with a related chronic disease ? Why doesn’t the bureaucrats use the taxes generated from sin taxes on Alcohol, Nicotine, Gambling to help fund the treatment of those dealing with various mental health issues of addictive personalities ?

 

The Opioids Crisis: Don’t Punish Pain Patients To Treat Opioid Addiction

https://washingtonmonthly.com/2021/08/19/the-opioids-crisis-dont-punish-pain-patients-to-treat-opioid-addiction/

Why a sin tax on opioids is not like a sin tax on sugary drinks.

The U.S. is suffering not one epidemic, but two: The opioid crisis continues to rage through the Covid-19 pandemic. In 2020, opioid deaths surged 30 percent to 93,000, the Centers for Disease Control (CDC) just announced, due largely to fentanyl, a potent synthetic opioid trafficked from Mexico and China. Federal action to help Americans combat substance abuse is urgently needed.

But a sin tax imposed in a new bipartisan Senate bill, The Life Budgeting for Opioid Addiction Treatment (LifeBOAT) Act, is sorely misguided, robbing pain patient Peter to treat addiction patient Paul.

Introduced by Senator Joe Manchin (D-West Virginia), along with ten co-sponsors including Senators Mitt Romney (R-Utah), Elizabeth Warren (D-Mass.), and Amy Klobuchar (D-Minn.), the bill would establish a tax on sales of opioids (“stewardship fee”) of one cent per milligram. The revenue would be earmarked to fund drug treatment.

New York State tried an opioid sin tax; the results were not encouraging. In 2019, it imposed taxes and fees on opioid manufacturers and pharmaceutical distributors that deliver opioids to pharmacies and hospitals.  According to Kaiser Health News, “scores of manufacturers and wholesalers stopped selling opioids in New York,” among them Epic Pharma, a manufacturer, and Independent Pharmacy Cooperative, a wholesaler. AvKARE and Lupin Pharmaceuticals no longer ship to New York.

Unable to recover their higher costs from insurers, some pharmacies raised prices, while others ceased carrying the medication altogether. Pain patients who relied on these medications struggled to fill their prescriptions.

A tax of one cent per milligram might not seem prohibitive, but the tax will cost many patients hundreds if not thousands of dollars per year. Roughly one-third of people receiving opioids in the U.S. take a daily dose of 90 mg or higher, according to data from IQVIA. With 5.4 percent of all adults taking opioids for long-term pain, millions of people will pay a surcharge for their care.

Such fees have proved much more effective at reducing access to pain medications than at raising revenue for drug treatment. New York’s anticipated $100 million fell short by seventy percent in 2020. A similar tax imposed by Delaware in 2019 generated $1 million in one year, a slow start to the $8 million projected by 2022.

A sin tax on opioids is different from, say, a sin tax on sugary drinks to subsidize insulin costs for people with diabetes. Ginger ale is not a medical product; Percocet, Vicodin, and morphine are.

Taxing opioids would compound pre-existing barriers that legitimate medical users must surmount to get pain relief. Guidelines issued in 2016 by the CDC were widely misinterpreted by physicians as a federal mandate to reduce opioid medication or cut patients off altogether, as the agency itself has acknowledged. One survey found that 71 percent of patients with chronic pain were getting a lower dose or were cut off completely. Eight out of ten said their pain and quality of life were worse.

The barriers imposed on pain patients have been called a “humanitarian crisis” by Human Rights Watch. The American Medical Association has also raised alarm about the harm to patients who require opioids.

Opioid taxes might even undermine the bill’s goal of fighting addiction by pushing users into the cheaper black market. In a 2021 online survey of nearly 4,000 pain patients, nine percent reported seeking opioids illegally when they were unable to obtain their medication through normal medical channels – risking addiction in the process.

No one can dispute that the aggressive marketing conducted by OxyContin-maker Purdue Pharma did the country significant damage. Nor the harm done when providers routinely prescribed an entire month’s supply of pills for short-term pain. But excessive prescribing declined 60 percent between 2011 and 2020. That didn’t keep the overdose death rate doubling over the same period, driven overwhelmingly by illegally-produced fentanyl. Politicians seem to have conflated the corporate misbehavior of Big Pharma with the problem of pain itself, which afflicts 50 million Americans and disables nearly 20 million.

Some patients who use prescribed opioids might benefit from other forms of pain management, but many alternatives are not widely available and are poorly covered by insurers. Doctors treat patients with the tools they have, not those they wish they had.

Drug treatment for opioid addiction is needed urgently, but Congress can and should fund it from other revenue sources. On July 29, the House passed a 2022 appropriations bill (awaiting Senate action) that would increase by more than 50 percent funding for the Substance Abuse Prevention, Treatment and Recovery Block Grant, and boost funding for other treatment programs. That’s a much better approach. People battling addiction need our help, but pain patients need it, too. The lifeboat is big enough for both.

 

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This is MORE than just getting rid of Medicare Part D. Right now, the FEDS are at fiscal risk for the cost of covered services by Medicare parts A&B. Medicare Part D is provided by FOR PROFIT INSURANCE COMPANIES.  There seems to be nothing mentioned in this to suggest that Medicare ADVANTAGE is going to be changed or eliminated…. and that Medicare prgm is provided by FOR PROFIT INSURANCE COMPANIES and typically provides coverage for medications.

So many pts will have no choice but to move over to a Medicare Advantage prgm, to get their necessary medications covered…. to some degree.

When Obama first proposed Obama Care… Medicare Part D copays were suppose to gradually change until in 2020… it would be a 80%/20% payment schedule- for all medications… SURPRISE… when 2020 Part D info was released for open enrollment for 2020… we got notified that we would have a NEW $435 annual deductible.  For years, – 2006 for Barb – we had Silver Scripts… which is now owned by CVS Health and uses Caremark as the PBM – which CVS Health also owned.

In using the Medicare website to check for other Part D providers… I discovered that Silver Scripts had been financially SCREWING US… Human Part D estimated that our costs would be much lower… in reality, in 2020 our total out of pocket copays – including the $435 deductible that we did not have in 2019  — was MORE THAN HALF than Silver Scripts charged us in 2019 with NO DEDUCTIBLE… Human’s premium was abt $1.00/month more …  We are taking the same meds and using the same independent pharmacy.

Generally with Medicare Advantage prgms, they have limited networks of providers ( prescribers, pharmacies, labs, hospitals ) none could be providers that you prefer to use. You use a “out of network provider” your copay or deductible could be DOUBLE or TRIPLE what you have to pay by using a in network provider or get no coverage at all.

What happens if the reimbursement that the Medicare Advantage program drops the $$$ that they offer a prescriber is “too low” and they claim that >50% of practicing prescribers are 55 + y/o and decide to retire.  All of a sudden mid-level practitioners ( ARNP, NP, PA, PharmD) before the primary care provider….  After all, mid-levels currently get reimbursed at abt 85% of what a MD would get paid for the same/similar service/treatment.

What would happen if/when 10% or so of Medicare folks remain on Part A&B, could Congress just tell them … Medicare Part A&B will cease to exist as of a certain date… chose a Medicare Advantage prgm by a certain date or we will assign you to one.

Then there are Medicaid pts…. most are getting their medications via a Part D prgm.. are the states going to have to reinvent “the wheel” or just go along and put all their Medicaid folks into a Medicare Advantage prgm – and then we would have > 50% of the population covered by Medicare Advantage prgm.

We have, at most. a handful of insurance companies controlling the vast majority of health insurance coverage/policies.

what happens if Congress mandates that everyone MUST HAVE HEALTH INSURANCE and EVERYONE will pay a certain percent of the gross income for a Medicare Advantage prgm… that would make those who think that the RICH SHOULD PAY MORE…  that would be a VERY PROGRESSIVE TAX and another step toward a national health insurance. Do you know these 3 Tips for Driving Through Heavy Construction? Find more about insurance plans here.

The last segment is the companies that are self insured ( ERISA ) prgms… as the FEDS won’t increase what they pay these Medicare Advantage … they may increase what they pay by 2%-3% when overall medical care cost is increasing 6%-8%… so these insurance companies will have to look at their internal overhead costs…  They may have to come to the conclusion that they are going to have to increase their administrative costs to manage self insured programs… or elect to get out of that service all together and give these self funded programs to sign their employees up to a Medicare Advantage type program or tell the large employer to manage their program themselves.

The graphic at the bottom of this post show where the “lion’s share” of the $$$ when a pt gets a Rx filled at their local pharmacy.

We have to remember that all it takes is one earthquake to create a tsunami and one “loose flake” to generate a avalanche.

 

 

Tell Washington To Protect Medicare

https://p2a.co/yK8Vsrd

 

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FDA Warns Again About Robotic Mastectomy, Breaks New Ground

https://www.medscape.com/viewarticle/957002

The US Food and Drug Administration (FDA) today issued a new safety communication about the use of robotically assisted mastectomy, warning patients and physicians that the safety and effectiveness of such devices have not been established in the prevention or treatment of breast cancer.

The agency also called out robotically assisted surgical (RAS) device use in the United States that lacks proper federal oversight.

“The FDA is aware of allegations that clinical studies are being conducted” with RAS devices in breast cancer “without the FDA oversight required for such significant risk studies,” the agency said.

The new advisory comes 4 weeks after a Medscape Medical News exclusive story on a set of clinical trials recently underway using RAS devices for nipple-sparing mastectomy, both prophylactically and as a breast cancer treatment.

The report found that investigators are either not collecting cancer outcomes or not doing so as a primary measure — despite a stiff warning in 2019 from the FDA that those outcomes are important. 

“Congratulations to the press on doing its job well and informing government. I think this [safety communication] is a direct result of Medscape following up on this issue,” said Hooman Noorchashm, MD, PhD, a patient advocate from Philadelphia. He is a former surgeon and faculty member at the University of Pennsylvania.

In reviewing the FDA’s new warning, Noorchasm pointed out that the agency also stated unequivocally — after previously hinting — that any study of robotic mastectomy “must include monitoring of long-term clinical outcomes” such as cancer recurrence, disease-free survival, and overall survival.

That’s a change in approach — previously the FDA has typically approved/cleared RAS devices for use in cancer surgery based on 30-day complication rates (compared with standards of care) and had no requirement for cancer-related outcomes data.

“This [new] advisory reiterates the need for a clear focus on primary oncologic outcomes to, at the very least, demonstrate the noninferiority of robotic assisted surgical devices for performing mastectomy procedures,” said Noorchashm.

In a 2019 warning about robotic mastectomy, the FDA suggested that it would require oncologic measures moving forward, saying that it “anticipates” that any evaluation of new use of robotic devices in women’s cancer “would be supported” by long-term cancer outcomes. But it stopped short of publicly saying so. The new advisory changes that.

Direct Comparison With Traditional Mastectomy Needed

There are safety concerns with robotic mastectomy. Experts question whether a surgeon can easily remove a breast tumor in one piece through the small incision (a selling point of the robot). If the tissue cannot be removed in one piece, cancer fragments may be left behind.

As a result, a randomized trial with traditional open mastectomy as a comparator is needed, Noorchashm stressed. The current batch of clinical trials in the United States are all single-arm studies and as such are “totally inappropriate,” he said last month.

Julie Margenthaler, MD, a breast surgeon at Washington University in St Louis, Missouri, also believes in the importance of a randomized trial.

“I feel strongly that robotic-assisted mastectomy should only be performed in the setting of a well-designed clinical trial and that oncologic outcomes should be a primary or secondary endpoint analysis as part of that trial,” she said in an email.

Intuitive Surgical, a California-based manufacturer of robotic devices in healthcare and a pioneer in robotic-assisted surgery, is funding one of the current clinical trials of robotic mastectomy in the United States — a single-arm, five center trial examining use in the prophylactic setting. The two primary outcomes are conversions to open mastectomy (efficacy measure) and the incidence of adverse events during surgery to 42 days after surgery (safety measure).

Medscape Medical News previously asked the company, which manufactures the market leader da Vinci robotic surgical equipment, if it planned on conducting a randomized trial.

“Any plans for use of da Vinci Xi surgical system in nipple-sparing mastectomy will be based on these [single-arm] study results as well as other data and evidence,” said a spokesperson, who did not confirm use of a randomized trial.

The new FDA requirement for long-term oncologic outcomes also in part arises from “diminished long-term survival” that was associated with robotic surgery and other minimally invasive surgery for hysterectomy related to cervical cancer.

Nick Mulcahy is an  award-winning  senior journalist for Medscape, focusing on oncology, and can be reached at  nmulcahy@medscape.net  and on Twitter:  @MulcahyNick

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Generally speaking, the DEA only wants Psychiatrist to write benzos for pts…  and that other docs should be the ones prescribing opiates – if the pt has a medical necessity for those two meds concurrently.  That is, unless the pt is in rehab for addiction and then it is perfectly OK for the same prescriber to take both for the pt. It would appear that this JAMA study … blows the DEA’s ideas about who should or shouldn’t prescribe these two categories OUT OF THE WATER.  I have repeatedly stated that it would appear that all the RED FLAGS and/or CAN’T DO THAT from the DEA comes from their observations of what substance abusers/addicts typically do.  NO DOUBLE BLIND CLINICAL STUDIES for the DEA to come up what is MEDICALLY APPROPRIATE or INAPPROPRIATE. Apparently, all the DEA’s “FACTS” about what is medically inappropriate, appears to be just observations/opinions by the DEA and they repeat them so many times …  that they somehow MAGICALLY become VALID CLINICAL FACTS.  and the DEA uses those “FACTS” to take prescribers to court, convict them of prescribing controlled substances to people who do not have a VALID MEDICAL NECESSITY.

Association Between Receipt of Overlapping Opioid and Benzodiazepine

Prescriptions From Multiple Prescribers and Overdose Risk

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2782842

Key Points

Question  Is overdose risk increased when overlapping opioid and benzodiazepine prescriptions are written by multiple prescribers vs 1 prescriber?

Findings  In this cohort study of 529 053 patients with private insurance or Medicare Advantage, overdose risk was increased 1.8-fold when opioid-benzodiazepine overlap involved prescriptions from multiple prescribers vs 1 prescriber. This increase remained statistically significant after adjusting for prescribing patterns, demographics, and comorbidities.

Meaning  This study found that observed factors did not fully account for the association between receipt of overlapping opioid and benzodiazepine prescriptions from multiple prescribers and overdose risk. This finding suggests that other factors, such as poor care coordination, may play a role.

Importance  The receipt of overlapping opioid and benzodiazepine prescriptions is associated with increased overdose risk. It is unknown whether this increase in risk varies when overlapping prescriptions are written by multiple prescribers vs 1 prescriber.

Objective  To evaluate the association between receipt of overlapping opioid and benzodiazepine prescriptions from multiple prescribers and overdose risk.

Design, Setting, and Participants  This cohort study was conducted using 2017 to 2018 claims from the Optum deidentified Clinformatics Data Mart. Participants were patients with private insurance or Medicare Advantage aged 12 years or older with overlapping opioid and benzodiazepine prescriptions. Data were analyzed from March through November 2020.

Exposures  For each patient, person-days on which opioid and benzodiazepine prescriptions overlapped were identified. The exposure was whether these prescriptions were written by multiple prescribers vs 1 prescriber.

Main Outcomes and Measures  The outcome was a treated overdose, defined as the occurrence of 1 or more claims containing a diagnosis code for opioid or benzodiazepine poisoning on a person-day of opioid-benzodiazepine overlap. The association between exposure and outcome at the person-day level was estimated using logistic regression, controlling for opioid and benzodiazepine prescribing patterns, demographics, and comorbidities. The average marginal effect (AME) of the exposure, defined as the absolute difference in the probability of a treated overdose if all person-days of overlap involved prescriptions from multiple prescribers vs 1 prescriber, was calculated.

Results  Among 529 053 patients, the mean (SD) age was 61.2 (15.6) years and 350 857 (66.3%) were female patients. Mean (SD) follow-up was 198.7 (249.8) days. During follow-up, overdose occurred on 1 or more person-days of opioid-benzodiazepine overlap for 2288 patients (0.4%, or 1 in 231 patients). There were 52 989 316 person-days of opioid-benzodiazepine overlap. Among 19 895 457 person-days (37.5%) involving prescriptions from multiple prescribers, there were 1390 overdoses (7.0 per 100 000 person-days), and among 33 093 859 person-days (62.5%) involving prescriptions from 1 prescriber, there were 1302 overdoses (3.9 per 100 000 person-days). Overdose risk was increased 1.8-fold (95% CI, 1.6-1.9) on person-days of overlap involving prescriptions from multiple prescribers vs 1 prescriber. The association between multiple prescribers and increased risk of overdose persisted in adjusted analyses (adjusted odds ratio, 1.20; 95% CI, 1.10-1.31; AME, 0.91 per 100 000 person-days of overlap; 95% CI, 0.46-1.37).

Conclusions and Relevance  This study found that among patients already at increased risk of overdose owing to concurrent treatment with opioids and benzodiazepines, overdose risk was increased further when multiple prescribers were responsible for this treatment regimen compared with 1 prescriber. This increased risk was not fully accounted for by differences in prescribing patterns, demographics, or comorbidities. This finding suggests that other factors, such as poor care coordination, may be associated with the increase in risk.

In each month of 2017, approximately one-fifth of US patients with dispensed opioid prescriptions had at least 1 day of overlapping opioid and benzodiazepine exposure.¹ During the first half of 2018, 32.5% of US opioid-related overdose deaths involved benzodiazepines.² The high prevalence of overlapping opioid and benzodiazepine prescriptions, coupled with the potential of this treatment regimen to increase overdose risk,^1–6 highlights the importance of avoiding concurrent treatment with opioids and benzodiazepines when possible and mitigating overdose risk when not possible.

There are several reasons to suspect that the receipt of overlapping opioid and benzodiazepine prescriptions from multiple prescribers may be associated with increased overdose risk compared with the receipt of overlapping prescriptions from 1 prescriber. In 1 study⁷ of patients with overlapping opioid and benzodiazepine prescriptions, those receiving these prescriptions from multiple prescribers had opioid prescriptions with more days supplied, higher daily dosages, and longer periods of overlap with benzodiazepine prescriptions, prescribing patterns that are associated with increased overdose risk. Furthermore, the receipt of overlapping opioid and benzodiazepine prescriptions from multiple prescribers may be associated with poor care coordination, which is a potential risk factor associated with overdose.⁸ Despite these considerations, no study to our knowledge has evaluated the association between the receipt of overlapping opioid and benzodiazepine prescriptions from multiple prescribers and overdose risk. Closing this gap may determine whether patients receiving overlapping prescriptions from multiple prescribers warrant targeted overdose-prevention efforts.

Using national claims databases, we identified patients with private insurance or Medicare Advantage aged 12 years or older who had overlapping opioid and benzodiazepine prescriptions during 2017 to 2018. We assessed whether overdose risk differed when opioid-benzodiazepine overlap involved prescriptions from multiple prescribers vs 1 prescriber.

Because data were deidentified, this cohort study was exempted from review by the institutional review board of the University of Michigan Medical School. The University of Michigan Medical School also determined that informed consent was not required because the data were deidentified. This study follows the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline for cohort studies.

From March to November 2020, we conducted a retrospective cohort analysis using the 2017 to 2018 Optum deidentified Clinformatics Data Mart. This database contains medical and pharmacy claims from 17 million to 19 million patients with private insurance or Medicare Advantage from all 50 states. Data elements include demographics, month of death (but not cause of death), diagnosis codes, prescription information (eg, days supplied and quantity), and unique clinician identifiers constructed by Optum based on known information about clinicians and business intelligence rules. We used 2016 data as a look back for variables requiring a baseline period.

We identified pharmacy claims for opioid and benzodiazepine prescriptions dispensed from 2017 to 2018 and the last quarter of 2016 (see eAppendix 1 in the Supplement for a list of medications). Opioids excluded opioid cough and cold medications. Following prior literature,^6,9 we converted opioid and benzodiazepine pharmacy claims to person-days of exposure that would have occurred if patients took medications as prescribed. This exposure period began on the dispensing date and ended on the dispensing date plus days supplied minus 1 day. Person-days of opioid-benzodiazepine overlap were those on which concurrent exposure to opioids and benzodiazepines occurred.

We included patients aged 12 years or older who had 1 or more person-days of opioid-benzodiazepine overlap from January 1, 2017, to December 31, 2018 (ie, the study period). Prescriptions dispensed in the last quarter of 2016 could contribute to person-days of opioid-benzodiazepine overlap in early 2017. The cohort entry date was the first person-day of opioid-benzodiazepine overlap during the study period. The cohort exit date was the earliest of the following: last person-day of overlap during the study period, first date of disenrollment from health insurance, or last day of the month of death. Analyses included only person-days of overlap between cohort entry and exit. Figure 1 depicts the study design.

To capture baseline comorbidities, we required continuous enrollment 365 days prior to cohort entry. We excluded patients with 1 or more person-days of opioid-benzodiazepine overlap between cohort entry and exit that derived from opioid or benzodiazepine prescriptions with missing or invalid dosing data (defined as quantity <0, days supplied <0, or days supplied >90), patients with 1 or more person-days of overlap between cohort entry and exit that derived from opioid or benzodiazepine prescriptions for which the clinician identifier was missing or mapped to a nonprescriber, patients with missing demographic data, and patients residing in Puerto Rico. For patients who died during follow-up (eg, patients who filled opioid or benzodiazepine prescriptions shortly before death), we excluded person-days of opioid-benzodiazepine overlap after the month of death.

The exposure was an indicator that equaled 1 if the number of unique clinician identifiers across opioid and benzodiazepine prescriptions active on the person-day was 2 or more (ie, there were multiple prescribers). If 3 prescriptions were active on the person-day (eg, 2 opioid prescriptions and 1 benzodiazepine prescription), the exposure variable equaled 1 even if 1 prescriber accounted for 1 of the 2 opioid prescriptions and the benzodiazepine prescription, while another prescriber accounted for the other opioid prescription. In this example, opioid-benzodiazepine overlap still involved prescriptions from multiple prescribers: the opioid prescription from the latter prescriber and the benzodiazepine prescription from the former. Patients could contribute person-days of overlap involving multiple prescribers only, person-days of overlap involving one prescriber only, or a mixture.

The outcome was a treated overdose, defined as the occurrence of 1 or more medical claims containing a diagnosis code for opioid or benzodiazepine poisoning on a person-day of opioid-benzodiazepine overlap (see eTable 1 in the Supplement for a list of codes). We included opioid and benzodiazepine poisoning codes, given that clinicians may use either for overdoses among patients with concurrent opioid and benzodiazepine use. When overdose claims occurred on consecutive person-days (eg, a multiday hospitalization for overdose), we assigned the overdose event to the first person-day. We considered overdose claims separated by 2 or more days to represent distinct overdose events.^6,10

We calculated daily opioid dosage in morphine milligram equivalents (MMEs), a standardized measure of opioid potency, by multiplying strength per dose, quantity, and published MME conversion factors, then dividing by days supplied (see eTable 2 in the Supplement for conversion factors used).^11,12 When multiple opioid prescriptions were active on a person-day, we summed daily MMEs across prescriptions. Following prior literature, we categorized daily MMEs as 0 to 30 MMEs, 30 to 59 MMEs, 60 to 89 MMEs, 90 to 119 MMEs, and 120 MMEs or more.⁶ A 30-MME increment represents the difference between prescribing 1 vs 2 pills containing 5 mg hydrocodone every 4 hours.

We calculated daily benzodiazepine dosage in diazepam milligram equivalents (DMEs) using a similar approach as for daily MMEs, but we used DME conversion factors from previous studies.¹³ Following prior literature,³ we categorized daily DMEs as 0 to 10 DMEs, 11 to 20 DMEs, 21 to 30 DMEs, 31 to 40 DMEs, and 40 or more DMEs.

We created an indicator for use of extended-release, long-acting opioids, defined as having 1 or more active prescriptions for these medications on the person-day. We classified extended-release, long-acting opioids based on master form (eg, extended-release patch) or opioid type (for types with no short-acting form).

We created indicators for comorbidities, including cancer, mental health disorders, substance use disorders, and tobacco use. Additionally, we created a variable for number of Elixhauser comorbidity flags,¹⁴ excluding those for cancer, mental health disorders, and substance use disorders. We defined comorbidities based on the presence of 1 or more claims with a corresponding diagnosis code on or during the 365 days prior to cohort entry (see eAppendix 2 in the Supplement for code list).

We included demographic variables, including age, sex, US Census region, and payer type (ie, Medicare Advantage vs private). We created an indicator for the year during which the person-day occurred (ie, 2018 vs 2017). Except for comorbidities, covariates were time varying.

Using descriptive statistics, we assessed patient characteristics at cohort entry. To describe the prevalence of the exposure, we calculated the proportion of patients who had person-days with the exposure only, had person-days without the exposure only, or had a mixture. Moreover, we calculated the proportion of person-days of overlap with and without the exposure. Using taxonomy codes, we determined which prescriber types most frequently accounted for the opioid exposure and benzodiazepine exposure on person-days of overlap (eAppendix 3 in the Supplement).

We calculated the proportion of patients with 1 or more overdoses between cohort entry and exit, the rate of overdose per 100 000 person-days of opioid-benzodiazepine overlap, the unadjusted risk ratio for overdose among person-days of overlap with and without the exposure, and the prevalence of covariates among person-days of overlap with and without the exposure. In adjusted analyses, we evaluated the association between the exposure and outcome using logistic regression, controlling for covariates. Models employed standard errors clustered at the patient level. This approach is analogous to a discrete-time survival analysis assuming a constant hazard function.¹⁵ Models did not include higher-order terms for continuous covariates, given that they were not statistically significant. To improve interpretability, we calculated the average marginal effect (AME) of the exposure, representing the absolute difference in the probability of overdose if all person-days of overlap involved prescriptions from multiple prescribers vs 1 prescriber, holding covariates at their observed values.¹⁶

We used SAS statistical software version 9.4 (SAS Institute), Stata/MP statistical software version 16 (StataCorp), and R statistical software version 3.6.3 (R Project for Statistical Computing). We conducted 2-sided hypothesis tests with a significance level of α = .05.

We conducted several sensitivity analyses. The main analysis included only overdoses on person-days of opioid-benzodiazepine overlap, given that defining covariates, such as daily opioid dosage, would be difficult on person-days with no opioid exposure. To assess whether conclusions would change if we included overdoses that occurred shortly after periods of opioid-benzodiazepine overlap, we identified person-days associated with overdose that occurred within 7 days and 30 days of the last person-day of a continuous period of opioid-benzodiazepine overlap and that were not included in the main analysis. We calculated unadjusted overdose risk overall and by exposure, assuming these person-days had the same exposure status as the last person-day of the continuous period and assuming the number of person-days of overlap in the sample remained constant.

In additional sensitivity analyses, we excluded person-days of overlap involving prescriptions from pain medicine physicians (in case this indicator was a proxy for unobserved confounders, such as pain severity or differences in treatment practices), excluded person-days involving buprenorphine (owing to controversy over its MME conversion factor), and excluded patients with cancer or substance use disorders. To test sensitivity to regression specification, we controlled for number of days since the beginning of an episode of opioid-benzodiazepine overlap (thus allowing for time-varying risk), used a thin plate smoothing spline function rather than modeling daily MME and daily DME as categorical variables,¹⁷ and did not control for daily MME, daily DME, or use of extended-release, long-acting opioids, given that prescribing patterns may be on the causal pathway between the exposure and outcome. Finally, we modeled the exposure variable as categorical (ie, 1, 2, or ≥3 prescribers).

Among 747 005 patients aged 12 years or older with 1 or more person-days of opioid-benzodiazepine overlap from January 1, 2017, to December 31, 2018, we excluded 207 952 patients (27.8%), leaving 529 053 patients (Figure 2). Table 1 displays sample demographic characteristics at cohort entry. The mean (SD) age was 61.2 (15.6) years, 350 857 (66.3%) were female patients, and 277 280 patients (52.4%) lived in the South. The mean (SD) duration of follow-up from cohort entry to exit was 198.7 (249.8) days.

Among 529 053 patients, 147 081 patients (27.8%) had person-days of opioid-benzodiazepine overlap involving prescriptions from multiple prescribers only, 233 508 patients (44.1%) had person-days of overlap involving prescriptions from 1 prescriber only, and 148 464 patients (28.1%) had a mixture. There were 52 989 316 person-days of opioid-benzodiazepine overlap (mean [SD], 100.2 [163.3] days per patient). Of these, 19 895 457 person-days (37.5%) involved prescriptions from multiple prescribers, while 33 093 859 person-days (62.5%) involved prescriptions from 1 prescriber.

Of 19 895 457 person-days of opioid-benzodiazepine overlap involving prescriptions from multiple prescribers, opioid prescriptions from pain medicine physicians were involved on 5 917 201 person-days (29.7%), compared with 3 765 569 person-days (18.9%) for internists and 3 041 792 person-days (15.3%) for family medicine physicians. Benzodiazepine prescriptions from family medicine physicians were involved on 5 706 768 person-days (28.7%), compared with 5 257 307 person-days (26.4%) for internists and 4 350 732 person-days (21.9%) for psychiatrists. Among 33 093 859 person-days of opioid-benzodiazepine overlap involving prescriptions from 1 prescriber, family medicine physicians accounted for 13 945 036 person-days (42.1%), compared with 11 045 193 person-days (33.4%) for internists and 2 009 865 person-days (6.1%) for nurse practitioners (Table 2).

Among 529 053 patients in the sample, 2288 patients had 1 or more overdoses between cohort entry and exit (0.4%, or approximately 1 in 231) and 404 patients (0.08%) had multiple overdoses. Among 52 989 316 person-days of opioid-benzodiazepine overlap, there were 2692 treated overdoses (5.1 per 100 000 person-days), of which 157 overdoses (5.8%) occurred during the month of death. Among 19 895 457 person-days of opioid-benzodiazepine overlap involving prescriptions from multiple prescribers, there were 1390 overdoses (7.0 per 100 000 person-days). Among 33 093 859 person-days of opioid-benzodiazepine overlap involving prescriptions from 1 prescriber, there were 1302 overdoses (3.9 per 100 000 person-days). The unadjusted overdose risk was increased 1.8-fold (95% CI, 1.6-1.9) for the former compared with the latter.

Table 3 displays the prevalence of covariates on person-days of opioid-benzodiazepine overlap involving prescriptions from multiple prescribers vs 1 prescriber. Person-days involving multiple prescribers, compared with those involving 1 prescriber, were more likely to have high-risk prescribing patterns, including daily MMEs of 90 or more (5 175 658 person-days [26.0%] vs 6 431 666 person-days [19.4%]) daily DMEs of 40 or more (2 657 762 person-days [13.4%] vs 3 157 074 person-days [9.5%]), and extended-release, long-acting opioid use (4 933 599 person-days [24.8%] vs 5 103 225 person-days [15.4%]), and were more likely to involve patients with mental health disorders (18 329 630 person-days [92.1%] vs 28 627 619 person-days [86.5%]) and substance use disorders (4 234 076 person-days [21.3%] vs 5 339 067 person-days [16.1%]).

The receipt of overlapping opioid-benzodiazepine prescriptions from multiple prescribers was associated with 1.20-fold (95% CI, 1.10-1.31) higher adjusted odds of overdose compared with the receipt of overlapping prescriptions from 1 prescriber. The adjusted rates of overdose if all vs no person-days involved prescriptions from multiple prescribers were 5.56 overdoses per 100 000 person-days of overlap and 4.65 overdoses per 100 000 person-days of overlap (AME of exposure, 0.91; 95% CI, 0.46-1.37). See eTable 3 in the Supplement for regression coefficients for covariates.

We identified 465 person-days associated with overdose that occurred within 7 days of the last person-day of a continuous period of opioid-benzodiazepine overlap and that were not included in the main analysis. If these 465 person-days had been included, the unadjusted risk difference between person-days of overlap involving prescriptions from multiple prescribers vs 1 prescriber would have been 3.6 overdoses per 100 000 person-days of overlap compared with 3.1 overdoses in the main analysis. We identified 728 person-days associated overdose that occurred within 30 days of the last person-day of a continuous period of opioid-benzodiazepine overlap and that were not included in the main analysis. If these 728 person-days had been included, the unadjusted risk difference between person-days of overlap involving prescriptions from multiple prescribers vs 1 prescriber would have been 4.1 overdoses per 100,000 person-days of overlap compared with 3.1 overdoses in the main analysis.

The positive association between exposure and outcome remained in all sensitivity analyses (eg, for the analysis excluding person-days of overlap involving prescriptions from a pain medicine physician, the AME was 0.87 [95% CI, 0.39-1.35]). When modeling the exposure as a categorical variable, the AME for 2 prescribers vs 1 prescriber was 0.83 (95% CI, 0.83-1.29), while the AME for 3 subscribers vs 1 prescriber was 2.57 (95% CI, 0.98-4.15) (eTable 4 in the Supplement).

In this national cohort study of more than 500 000 patients with private insurance or Medicare Advantage, the unadjusted risk of overdose was increased 1.8-fold when opioid-benzodiazepine overlap involved prescriptions from multiple prescribers vs 1 prescriber. After controlling for differences in prescribing patterns, demographic characteristics, and comorbidities, the adjusted odds of overdose were 1.2-fold higher when opioid-benzodiazepine overlap involved prescriptions from multiple prescribers. This estimate corresponds to approximately a 20% increase in the risk of overdose, as odds ratios and risk ratios are similar when outcomes are rare. These findings suggest that among patients already at increased risk for overdose owing to concurrent treatment with opioids and benzodiazepines, risk is increased further when multiple prescribers are responsible for this treatment regimen.

Consistent with prior work,⁷ person-days of opioid-benzodiazepine overlap involving prescriptions from multiple prescribers were more likely to be associated with high-risk prescribing patterns, including high daily opioid and benzodiazepine dosages. However, after adjusting for these differences in prescribing patterns, as well as differences in demographic characteristics and comorbidities, the positive association between receipt of overlapping opioid and benzodiazepine prescriptions from multiple prescribers and overdose risk remained. This finding does not imply that the association is causal, given that the involvement of multiple prescribers does not increase the ability of opioids and benzodiazepines to depress respiration. Rather, these findings imply that the association is driven by factors not measured directly in analyses.

Given the lack of clinical details in claims data, we cannot definitively identify these factors. However, we speculate that 1 such factor may be poor care coordination. For example, prescribers of opioids may be unaware that patients have active benzodiazepine prescriptions owing to differing systems for tracking prescription use. Opioid prescribers may therefore miss opportunities to implement strategies to prevent overdose, such as naloxone coprescribing. A 2019 study⁸ found that the dual receipt of opioid prescriptions covered by the Veterans Administration and by Medicare Part D was associated with fatal opioid overdose, potentially consistent with the notion that poor care coordination may be associated with increased overdose risk.

In our study, 1 of 231 patients experienced an overdose during follow-up. This finding suggests the importance of avoiding overlapping opioid and benzodiazepine prescriptions when possible, regardless of whether prescriptions are written by multiple prescribers or 1 prescriber. That said, the greater risk among patients receiving overlapping prescriptions from multiple prescribers suggests that targeted interventions may be warranted for these patients. For example, if electronic health record systems are linked to prescription drug–monitoring program databases, an alert to coprescribe naloxone could be created for clinicians who order opioid prescriptions for patients with an active benzodiazepine prescription from another prescriber (or the reverse). Our findings suggest that such interventions should focus on pain medicine physicians, internists, family medicine physicians, and psychiatrists, given that these clinicians were frequently involved on person-days of opioid-benzodiazepine overlap involving prescriptions from multiple prescribers.

This study has several limitations. First, as noted above, we cannot determine whether the demonstrated association is driven by poor care coordination, owing to data limitations. Second, it is unclear whether results generalize to patients without insurance or to patients covered by Medicaid or traditional Medicare. Third, 157 overdoses occurred during the month of death, but it was unclear whether deaths were due to overdose. Fourth, analyses likely undercounted the number of overdoses. Opioid and benzodiazepine poisoning codes have imperfect sensitivity for detecting overdose, although they are likely highly specific.¹⁸ Moreover, our database captured only treated overdoses resulting in claims. Perhaps most importantly, we counted only overdoses occurring during periods of opioid-benzodiazepine overlap. Our sensitivity analysis, however, suggested that including overdoses that occurred within 7 days and 30 days of the end of a period of opioid-benzodiazepine overlap would have resulted in a greater unadjusted risk difference than that found in the main analysis.

This study found that the receipt of overlapping opioid and benzodiazepine prescriptions from multiple prescribers was associated with increased overdose risk compared with the receipt of overlapping prescriptions from 1 prescriber.

This increased risk was not fully accounted for by differences in prescribing patterns, demographics, and comorbidities. Further studies are needed to determine the mechanism associated with this increased risk.

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This story is so strange… you almost need a road map to follow all the twists and turns ….  Michael DeAngelis is the regular spokesperson for CVS with the media… and his statement seem to be pretty clear that CVS is using GROSS DISPENSING DATA – and not clinical data to make “clinical decisions” that a prescriber is writing too many controlled substances…   “It is alleged in many lawsuits that pharmacies fill too many opioid prescriptions and should operate programs that use data to block prescriptions written by some doctors ”  There is a phrase in the controlled substance act “corresponding responsibility”… which basically means that both the prescriber and the pharmacist are responsible to make sure that prescribed opiates are for valid medical necessity..  The intent of this law is that both prescriber and pharmacist are both responsible to make sure that a pt with a medical need for opiates get the controlled substance that they have a valid medical necessity for.  It would appear to me, that according to Mr DeAngelis statement… the decision to stop filling this pain clinic’s controlled meds prescription was made by CVS Health  THE CORPORATION…. which has neither a pharmacist degree, nor pharmacist license and since one the basics of the practice of medicine is the starting, changing, stopping a pt’s therapy…  so it would also appear that CVS Health THE CORPORATION made a decision to stop the therapy of all of the pts of this clinic…. so apparently they could also be guilty of practicing medicine without a license and intentionally throwing hundreds of pts into cold turkey withdrawal.

According to this quote in this article  …  Kahra Lutkiewicz, director of CVS’ retail pharmacy professional practice, wrote in the letter. “Thus, we are writing to inform you that effective August 5, 2021, CVS/pharmacy stores will no longer be able to fill prescriptions that you write for controlled substances. We take our compliance obligations very seriously, and after careful consideration, find it necessary to take this action.”    According to information on FB and LinkedIN indicates that Ms Lutkiewicz  has been a licensed pharmacist, for about 20 yrs and she is the one who seem to indicate that she is the primary CVS Health employee who made this decision to cut this pain clinic and all its pts off…  Could she also be responsible for practicing medicine without a license ?

It also appears that Dr Hansen was sued 2 yrs ago In 2019, a patient sued him for negligence and fraud for allegedly performing medically unnecessary and excessive injection therapy. The suit claims the patient was required to undergo injection therapy on a continuing basis in order to receive her narcotic pain medication, according to the lawsuit filed in Kenton Circuit Court. The complaint alleges that Hansen made false representations to the patient and to her i nsurers that the injections were necessary for the treatment of the patient’s chronic pain.

I am no attorney but this seems to be a straight forward case of a violation of parts of the Sherman Antitrust act referred to as “Tying Commerce ”  https://en.wikipedia.org/wiki/Tying_(commerce)

that law is basically that a vendor will require a customer to purchase something that they don’t want to be able to purchase something that they do want. According to that lawsuit,  Dr Hansen was requiring pts to get ESI’s in order for Dr Hansen to provide the pt with a Rx for oral opiates and/or other controlled substances.

It is buried somewhere in the Federal Anti -Kickback Statute and/or Stark act, but it is something should be explored.

Everyone seems to be a “HOT MESS” to some degree… except the poor intractable chronic pain pts that were pts of Dr Hansen’s pain clinic.

Doctor Wins Restraining Order Against CVS After Prescription Ban

https://www.medscape.com/viewarticle/956705 

A Kentucky pain specialist has won a temporary restraining order against CVS Pharmacy after the retail chain forbade its pharmacies to fill his prescriptions.

In an August 11 decision, District Court Judge William Bertelsman ordered CVS to stop refusing prescriptions written by Kendall E. Hansen, MD. Judge Bertelsman ruled that Hansen is likely to succeed in his claim that CVS barred his prescriptions without evidence that he violated any law or professional protocol. The restraining order will remain in place while Hansen’s lawsuit against CVS Pharmacy proceeds.

Ronald W. Chapman II, an attorney representing Hansen, said the order is groundbreaking and that to his knowledge, it’s the first time a federal court has overturned a pharmacy’s decision to block a prescriber.

“We believe that CVS’ decision was based solely on algorithms they use to analyze prescriber practices and not an any individual review of patient records,” Chapman said. “In fact, we invited CVS to come out to Dr Hansen’s practice and look at how he was treating patients and ensure things were compliant, but they refused. Instead, they had a phone call with him then cut his patients off.”

Michael DeAngelis, a spokesman for CVS, said the court’s order illustrates the proverbial rock and hard place that pharmacies are placed between in the country’s fight against the misuse of prescription opioids.

“It is alleged in many lawsuits that pharmacies fill too many opioid prescriptions and should operate programs that use data to block prescriptions written by some doctors,” DeAngelis wrote in an email to Medscape Medscape News. “And yet other lawsuits, including this one, argue that we should not operate programs that may block prescriptions. Such contradictions are grossly unfair to the pharmacy profession.”

DeAngelis declined to comment about Hansen’s claims or specify what led CVS to refuse his prescriptions.

Hansen declined to comment for this story through his attorney.

 

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I rode by one the chain pharmacies stores yesterday… you know the one some refer to as the THREE LETTER CHAIN.  On their “road sign” they were advertising “GET YOUR FLU SHOT”…. there is four main influenza viruses exist: A, B, C, and D.  A&B is the most common types that affect humans, but there is A total of 131 sub-types  (mutations) of influenza A have been identified to date.

Our healthcare system pharma system looks for which varieties are circulating south of the equator during our summer period which is there winter period and make flu shots for USA based on what is prevalent “down south”. 

Each year, it is unusual for the same mutation to be prevalent the following winter.  That is why the flu shot has become a annual happening…

Also the flu vaccines and the antibody titters that they create tend to wane over time.  The “peak” of a flu season can vary from Dec thru March on any given year.

People are at risk by getting their flu shot in July or Aug, because their antibody titters will be reduced by the time peak flu season rolls around, but apparently some chain pharmacies are more interested in generating revenue… maybe even be able to get to give a SECOND FLU SHOT if the flu season peaks in March… because those pts who got a shot in July/Aug.. their antibody titters could be TOO LOW and justify them getting a second flu shot…  what the hell … just more revenue for the chain that convinced them to get their ANNUAL FLU VACCINATION way too early.

The CDC estimates that upwards of 60,000 people die every year from the flu and of course, if a person dies from getting their flu shot too early and ends up catching the flu and dying… unlikely that whoever encouraged the pts to get a very early flu shot, will not experiences and financial consequences… Getting the flu shot – even on a timely manner….does not mean that they won’t catch the flu.

Personally, we try to get our annual flu vaccinations the last week of Sept or the first week of Oct.  It takes abt two weeks for antibodies to develop, so even if the flu season is very early – like starting in Nov… we should be covered for the entire flu season.

 

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Guest Opinion: AARP and the triumph of image over skeezy reality

https://www.goerie.com/story/opinion/2021/08/04/guest-opinion-aarp-and-triumph-image-over-skeezy-reality/5468308001/

By Marion Mass

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